PharmaShots' Key Highlights of Fourth Quarter 2022

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PharmaShots' Key Highlights of Fourth Quarter 2022


  • The fourth quarter of 2022 highlights approvals, multiple clinical trial results, and numerous deals. There are major alliances in this quarter which include Johnson & Johnson acquired Abiomed for ~$16.6B, Takeda entered into an agreement to acquire NDI-034858 from Nimbus Therapeutics for ~$6B
  • In the fourth quarter of the year, BeiGene’s Brukinsa received EC’s approval for MZL while Exelixis collaborated with Sairopa to develop ADU-1805 for cancer. Meanwhile, Bayer’s Aflibercept met its primary endpoint to treat neovascular age-related macular degeneration and diabetic macular edema
  • Our team at PharmaShots has summarized and complied with the insights of Q4'22

1. Janssen Presents P-I/II (MGT009) and P-I Study Results of Two Gene Therapy Programs for X-Linked Retinitis Pigmentosa and Dry AMD at AAO 2022

Date - Oct 03, 2022                                                  

Product - botaretigene sparoparvovec                                               

  • The P-I/II (MGT009) dose-escalation study evaluated botaretigene sparoparvovec in 49 patients aged ≥5yrs. with XLRP associated with RPGR gene
  • The results showed an acceptable safety profile & efficacy, improvement in retinal sensitivity, visual function & functional vision, and improvement in walk time @26wk. b/w the treated eyes in low & intermediate dose cohorts & untreated eyes in the randomized concurrent control arm at low illumination levels. The safety profile was consistent with prior reports, AE was anticipated & manageable with no dose-limiting events
  • The company also presented the results from the P-I study of 3 doses of JNJ-1887 for dry AMD with GA which met the 1EPs of safety over 2yr. follow-up period & continual decline in lesion growth over 6mos.

2. Sanofi Entered into an Exclusive License Agreement with miRecule to Advance Antibody-RNA Conjugate for Facioscapulohumeral Muscular Dystrophy

Date - Oct 04, 2022                                                  

Product - N/A

  • miRecule to receive ~$30M up front incl. near-term milestones & is also eligible to receive ~$400M in development, regulatory, and commercial milestones to advance FSHD drug candidate along with royalties on global net sales of the approved product. Both companies collaborated on research activities through lead candidate selection 
  • Sanofi gets an exclusive license to IP rights globally for FSHD therapy (developed and commercialized by Sanofi) & will be responsible for IND enabling studies along with development and commercialization activities globally
  • The collaboration combines miRecule’s anti-DUX4 RNA therapy with Sanofi’s NANOBODY technology for Ab-RNA conjugate (ARC) to treat FSHD by using NAVIgGator conjugation and formulation chemistry

3. Roche’s CDx Test Receives the US FDA’s Approval for HER2 Low Metastatic Breast Cancer

Date - Oct 06, 2022                                                  

Product - Enhertu

  • The US FDA has approved the PATHWAY anti-HER2/neu (4B5) Rabbit monoclonal primary Ab as CDx to identify patients with mBC with low HER2 expression who may be eligible for Enhertu
  • The test can be used to standardize immuno-histochemistry (IHC) processes & decrease human error in the laboratory setting. It also includes an algorithm that allows pathologists to score HER2 expression & identify the low expression
  • Enhertu will be commercialized by AstraZeneca & Daiichi Sankyo, based on the results of the P-III (DESTINY-Breast04) trial. The results showed a 50% reduction in risk of disease recurrence or death and an overall gain of 6mos. over SoC in low-expression HER2 patients treated with Enhertu

4. Eli Lilly’s Tirzepatide Receives the US FDA’s Fast Track Designation for the Treatment of Obesity

Date - Oct 06, 2022                                                  

Product - Tirzepatide

  • The US FDA has granted FTD to tirzepatide for obesity, or overweight with weight-related comorbidities. The P-III (SURMOUNT-1) trial evaluates tirzepatide (5/10/15mg) vs PBO in a ratio (1:1:1:1) in 2539 adult patients without T2D across the US, Argentina, Brazil, China, India & other countries
  • The co-primary objectives of the study showed that tirzepatide (10/15mg) was superior in the percentage of body weight reductions from baseline and patients achieved ≥5% body weight reduction @72wk. The P-III (SURMOUNT-2) are expected to complete at the end of April 2023
  • The company plans to initiate a rolling submission of NDA for tirzepatide for obesity or overweight in 2022, based on 2 P-III (SURMOUNT-1 & 2) trial results

5. Merck and Ridgeback Report Results for Lagevrio in P-II Studies for the Treatment of COVID-19

Date - Oct 07, 2022                                                  

Product - Lagevrio

  • The (PANORAMIC) trial evaluates the safety & efficacy of Lagevrio (800mg, BID) + usual care vs usual care in patients (n=25,783) aged ≥50yrs. with COVID-19. The study showed no reduction in hospitalizations & death @28days of randomization whereas the 2EPs was 6days shorter with usual care vs without usual care
  • The (Clalit) trial evaluates the real-world effectiveness of Lagevrio in patients (n=19,868) aged ≥65yrs. for the prevention of COVID-19 with results showing a reduction in hospitalization & mortality in patients aged ≥65yrs. along with no evidence of benefit found in patients aged 40-64yrs.
  • The (Tg RasH2) study evaluating the carcinogenicity of Lagevrio in transgenic mice receiving molnupiravir (30/100/300mg/kg/day) for 6mos. showed that Lagevrio was not carcinogenic

6. Abbott Reports New (FLASH-UK) Trial Results of FreeStyle Libre 2 System for Type 1 Diabetes and Sub-Optimal Glycemic Control

Date - Oct 07, 2022                                                  

Product - FreeStyle Libre 2 System

  • The (FLASH-UK) trial evaluates the FreeStyle Libre 2 system vs self-monitoring of blood glucose (SMBG) in a ratio (1:1) in 156 patients aged ≥16yrs. with T1D. The trial was led by a team at The University of Manchester together with investigators from 8 centers in the UK & funded by Diabetes UK
  • The results showed reductions in HbA1c levels @24wks., improvements in patients-reported QoL outcomes incl. overall satisfaction & reduction in burden associated with glucose monitoring. The results were published in the NEJM
  • Patients who used FreeStyle Libre 2 system achieved a reduction in HbA1c levels by an avg. of 0.8% (8.7% to 7.9%) after 6mos. over 0.2% (8.5% to 8.3%) in SMBG, avg. HbA1c level was 0.3% lower @12wks. & 0.5% lower @24wks. than those using SMBG

7. Lilly to Acquire Akouos for ~$610M

Date - Oct 13, 2022                                                  

Product – N/A

  • Lilly to acquire all outstanding shares of Akouos for a purchase price of $12.50/share (~ $487M) represents a premium of ~121% to the 30-day volume-weighted avg. price of Akouos's common stock ended on Oct 2022 & non-tradeable CVR per share of ~$3.00 in cash for a total consideration of ~$15.50/share (~$610M). The transaction is expected to close in Q4’22
  • CVR holders will receive $1.00 for the 5th participant treated with AK-OTOF in P-I or P-I/II trial for hearing loss due to mutations in the otoferlin gene
  • $1.00 with Akouos gene therapy for 2nd monogenic form of sensorineural hearing loss (excl. AK-OTOF & AK-antiVEGF) & $1.00 with gene therapy product (excl. AK-antiVEGF) in the P-III trial. Akouos stockholders will hold ~26% of Akouos's outstanding common stock

8. AUM Biosciences to Go Public through Reverse Merger with Mountain Crest for Oncology Therapeutics

Date - Oct 21, 2022                                                  

Product - AUM001 & AUM601

  • The combined company will receive ~$69M in cash, AUM stakeholders will receive $40M shares of the combined company in exchange for AUM stocks at $10/share whereas each Mountain Crest's unredeemed outstanding share & every 10 SPAC rights will be converted into 1 share of the combined company
  • The merger is expected to close in Q1’23 & the combined company will be listed on Nasdaq under the ticker symbol, AUMB
  • AUM’s AUM001 & AUM601 are being evaluated in the P-II study for cancer indications out of which the study evaluating AUM001 expects to begin enrolment of patients by Q4’22 whereas AUM302 is designed to combine pan-PIM kinase, pan-PI3K, and mTOR inhibition in a single agent to treat the same indication

9. LEO’s Adtralza Receives EC's Approval for the Treatment of Moderate to Severe Atopic Dermatitis

Date - Oct 21, 2022                                                  

Product - Adtralza

  • The approval was based on the P-III (ECZTRA 6) trial evaluating the safety & efficacy of Adtralza monothx. (150/300mg) vs PBO in adolescents (n=289) aged 12-17yrs. with moderate-to-severe AD who were candidates for systemic therapy
  • Post washout period patients were given Adtralza (Q2W) or PBO initially for 16wks. & dosing of Adtralza started with 300 or 600mg on day 0 for patients receiving 150/300mg, Q2W. Patients responding to Adtralza @16wks. with an IGA score of 0/1 and/or 75% EASI change from baseline were randomized to Adtralza (Q2W/Q4W) for an additional 36wks.
  • Adtralza is a high-affinity human mAb that binds to & inhibits the IL-13 cytokine responsible for the immune & inflammatory processes underlying AD, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits

10. Sumitovant and Sumitomo to Acquire Myovant Sciences for ~$1.7B

Date - Oct 25, 2022                                                   

Product – N/A

  • Sumitovant will acquire all outstanding shares of Myovant for $27.00/share in cash representing a premium of ~50% to Myovant’s closing share price with a total deal value of $1.7B on a fully diluted basis, and a total company value of $2.9B. The transaction is expected to close in Q1’23
  • The agreement combines expertise, platforms & resources to commercialize products in Myovant’s program & advance the development of a robust pipeline for prostate cancer
  • The agreement offers Sumitomo access to Myovant's clinical assets and treating infertility in women along with the US FDA-approved drugs for prostate cancer & menstrual bleeding. Myovant will become a wholly owned subsidiary of Sumitovant, Sumitovant will own ~52% of the outstanding shares of the Myovant

11. Johnson & Johnson to Acquire Abiomed for ~$16.6B

Date - Nov 2, 2022                                                  

Product – N/A

  • J&J to acquire all outstanding shares of Abiomed for an up front of $380.00/share representing a 50.7% premium over its closing price of $252.08 at an enterprise value of ~ $16.6B. Abiomed shareholders will receive a non-tradeable CVR of ~$35.00/share upon milestones achievement & the transaction is expected to be close in Q1’23
  • The milestones fees incl. $17.50/share, if net sales for Abiomed products exceed ~$3.7B at J&J’s fiscal Q2’27 through fiscal Q1’28, $7.50/share upon FDA premarket application approval of Impella products, $10.00/share in 1st publication of a Class I recommendation for Impella products
  • The acquisition expands JJMT’s portfolio with a leading platform in HF, SoC, market opportunity through a robust pipeline of technologies & clinical studies, near & long-term sales, and earnings growth

12. Exelixis Entered into an Exclusive Clinical Development Collaboration and Option Agreement with Sairopa to Develop ADU-1805 for Cancer

Date - Nov 2, 2022                                                  

Product – ADU-1805

  • Sairopa to receive ~$40M and an additional $70M in near-term milestones for an option to obtain an exclusive license globally for ADU-1805 and other anti-SIRPα antibodies, ~$97.5M in success-based development milestone during the option period & an additional $465.0M upon achievement of specified clinical, commercial and net sales milestones along with royalties on net sales globally
  • Upon the completion of the clinical studies, Exelixis get the right to exercise its option for an option exercise fee of $225M based upon an evaluation of a pre-specified clinical data package to be delivered by Sairopa
  • The acquisition expands Exelixis’ clinical pipeline & also expands the potential clinical and commercial value of ADU-1805

13. BeiGene’s Brukinsa (zanubrutinib) Receives EC’s Approval for the Treatment of Adults with Marginal Zone Lymphoma

Date - Nov 2, 2022                                                   

Product – Brukinsa

  • The EC has granted marketing authorization of Brukinsa for r/r MZL who have received one prior anti-CD20-based therapy
  • The approval was based on results from the P-II (AGNOLIA) trial which showed a high ORR of 68% with 26% of patients achieving CR as assessed by IRC, responses were observed in all patients regardless of MZL subtypes along with a rapid and durable disease control with a median time to response of 2.8mos., was well-tolerated and safety was consistent with its established profile, low rates of discontinuation due to AEs (3.5%)
  • The EC’s approval will apply to all 27 member states of the EU, Iceland, and Norway. Brukinsa has been approved in the EU for adult patients with WM

14. Bayer Reports P-III (PULSAR) and P-II/III (PHOTON) Trial Results of Aflibercept for Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema

Date - Nov 07, 2022                                                  

Product – Aflibercept

  • The P-III (PULSAR) trial in nAMD & P-II/III (PHOTON) trial in DME evaluated aflibercept (8mg) with 12 and 16wk. dosing regimens vs Eylea (2 mg, q8w)
  • The trial met its 1EPs of non-inferiority of aflibercept for BCVA @48wk., following initial monthly doses, 77% of nAMD & 89% of DME patients maintained q16w dosing intervals while 83% & 93% at ≥12wks. @48wk. in the pooled analysis & showed sustained visual acuity. The safety was consistent with the well-established safety profile of Eylea
  • Rates of intraocular inflammation (0.7% vs 0.6%) & (0.8% vs 0.6%) in both trials; patients with IOP ≥35mmHg pre or post-inj. (0.6% vs 0.3%) & (0.2% vs 1.2%), no cases of occlusive retinal vasculitis or endophthalmitis were seen & non-ocular events were balanced with no new signals

15. Sanofi Entered into a Research Collaboration with Insilico Medicine for ~$1.2B

Date - Nov 09, 2022                                                   

Product – N/A

  • Insilico Medicine to receive ~$21.5M up front and target nomination fees for ~6 targets & is also eligible to receive ~$1.2B upon achievement of research, development, and sales milestones along with royalties
  • In return, Sanofi gets the benefit from Insilico’s end-to-end Pharma.AI platform & will receive access to the company’s scientific team to identify, synthesize, and advance high-quality lead therapeutic compounds up to development candidate stage
  • The collaboration helps to advance the development candidates for ~6 new targets by using Insilico Medicine’s AI platform, Pharma.AI & Sanofi’s strong drug research, and development expertise

16. AstraZeneca Reports P-III (DELIVER) Trial Results of Farxiga (dapagliflozin) for Heart Failure Associated with Mildly Reduced or Preserved Ejection Fraction

Date - Nov 09, 2022                                                  

Product – Farxiga

  • The P-III (DELIVER) trial evaluating Farxiga (qd) + SoC vs PBO in 6263 patients with HF with LVEF ≥40% with/out T2D
  • The results showed an improvement in symptom burden and health-related QoL in patients with HF and mildly reduced or preserved EF, clinical benefits were observed, and benefits were sustained @8mos. with a mean improvement in total symptom score. The results were presented at AHA 2022 & published in the JACC
  • Patients achieved a significant deterioration, improvements in health status across evaluated KCCQ domains, and benefits of Farxiga on CV death & worsening HF. The safety & tolerability profiles were consistent with the well-established safety profile of the therapy

17. Pfizer and BioNTech Receive EMA’s CHMP Positive Opinion Recommending Marketing Authorization for Omicron BA.4/BA.5- Bivalent Booster Vaccine

Date - Nov 11, 2022                                                  

Product – COVID-19 Vaccine

  • The EMA’s CHMP has adopted the positive opinion recommending marketing authorization for a booster dose of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children aged 5-11yrs. The EC’s final decision is expected shortly
  • The recommendation was based on safety & immunogenicity data from the Omicron BA.1-adapted bivalent vaccine in individuals aged ≥12yrs., initially approved 10µg pediatric formulations of the COVID-19 vaccine, manufacturing data from pediatric formulation & preclinical data from Omicron BA.4/BA.5-adapted bivalent vaccine
  • The P-II/III trial results showed that booster vaccine in adults aged ≥18yrs. elicited a strong immune response against BA.4 & BA.5 sublineages, safety & tolerability profile similar to the COVID-19 vaccine

18. Janssen Reports Post-Hoc Analysis of Tremfya (guselkumab) in P-III (DISCOVER-2) Study for Active Psoriatic Arthritis

Date - Nov 11, 2022                                                  

Product – Tremfya

  • The P-III (DISCOVER-2) study evaluating Tremfya (SC) vs PBO in 739 biologic-naïve patients with active PsA
  • The results showed clinical improvements in most measures, improvements in overall & physical HRQoL from 1-2yrs. in early clinical responders over patients without early response while long-term HRQoL benefits were also observed in non-early responders treated with Tremfya
  • Additionally, a significant benefit for reducing fatigue as early as 8wk. was observed over PBO. In a separate post-hoc analysis, improvements in fatigue @1yr. resulted in greater proportions of patients achieving normative FACIT-F levels, improvement of ≥2 points in FACIT-F by 8wk. that predicted an improvement of ≥4 points @100wk.

19. Merck Entered into a Definitive Agreement to Acquire Imago BioSciences for ~$1.35B

Date - Nov 22, 2022                                                  

Product – IMG-7289

  • Merck to acquire Imago for $36.00/share in cash for a total equity value of $1.35B. The transaction is expected to close in Q1’23
  • The acquisition will use Merck’s industry-leading clinical development expertise to maximize the therapeutic potential of bomedemstat for patients with myeloproliferative neoplasms. The acquisition also strengthens Merck’s growing hematology portfolio
  • Additionally, Imago’s bomedemstat (IMG-7289) is an orally available LSD1 inhibitor & is currently being studied in multiple P-II clinical trials for essential thrombocythemia (ET), MF, and PV along with other indications

20. Daiichi Sankyo’ Enhertu (trastuzumab deruxtecan) Receives the MHLW Approval for the Treatment of HER2 Positive Metastatic Breast Cancer

Date - Nov 25, 2022                                                  

Product – Enhertu

  • MHLW has approved Enhertu for the treatment of HER2+ unresectable or recurrent breast cancer after prior CT incl. trastuzumab and a taxane
  • The approval was based on the P-III (DESTINY-Breast03) trial evaluating the efficacy & safety of Enhertu (5.4mg/kg) vs T-DM1 in 524 patients at multiple sites in Asia, EU, North America, Oceania & South America. The results showed a 72% reduction in risk of disease progression or death, m-PFS (not reached vs 6.8mos.) & the safety profile was consistent with prior trials with no new safety concerns
  • Enhertu (5.4mg/kg) was approved in 35+ countries for unresectable or metastatic HER2+ breast cancer, based on the results from the (DESTINY-Breast03) trial

21. Boehringer Ingelheim Reports P-III (VOLTAIRE-X) Trial Results of BI 695501 (biosimilar, adalimumab) for Chronic Plaque Psoriasis

Date - Nov 26, 2022                                                   

Product – BI 695501

  • The P-III (VOLTAIRE-X) trial evaluates BI 695501 vs Humira in 259 patients at 49 sites across EU & North America
  • PK equivalence was demonstrated with highly similar efficacy, clinical outcomes, and immunogenicity, comparable safety was observed who received adalimumab RP continuously or who switched b/w adalimumab RP and BI 695501
  • At 32wk., 85% & 79% of patients in switching & continuous groups had a 75% reduction in PASI scores; 70% & 65% had a static sPGA response of 1 or lower (clear or almost clear); 90% & 95% developed anti-drug Abs; 41% & 42% neutralizing Abs; TEAEs related to study treatment (12% & 18%); treatment discontinuation due to TEAEs in 0.8% & 1.7%, PASI scores were highly similar across the entire trial period, respectively

22. BMS’ Opdivo (nivolumab) Receives NICE Recommendation as 1L Treatment for Rare Gastroesophageal Cancers

Date - Nov 28, 2022                                                 

Product – Opdivo

  • The NICE has issued a final draft guidance recommending BMS’ Opdivo + CT as a treatment option for untreated HER2-, advanced or metastatic gastric, GEJ, or oesophageal adenocarcinoma in patients whose tumors express PD-L1 with a CPS of ≥5
  • The decision was based on the P-III (Checkmate-649) trial evaluating Opdivo (360mg, q3w or 240mg, q2w) + CT vs CT alone in patients which showed an improvement in OS & PFS, m-OS (14.4mos. vs 11.1mos.), m-PFS (8.31mos. vs 6.05mos.), significant OS benefit was also observed in PD-L1+ patients with CPS ≥1 & in the all-randomized population
  • The safety profile was consistent with the known safety profiles of the individual treatments & no new safety signals were reported

23. Immutep Enters into a Clinical Trial Collaboration with Merck KGaA and Pfizer to Evaluate Eftilagimod Alpha (Efti) for Urothelial Cancer

Date - Nov 30, 2022                                                 

Product – Eftilagimod

  • Under the terms of the agreement, Immutep & Merck KGaA will jointly fund the clinical trial (INSIGHT-005) whereas the Institute of Clinical Cancer Research will conduct the study as part of the INSIGHT platform that consists 5 arms from stratum A to E
  • The stratum E arm, clinical trial (INSIGHT-005) is expected to evaluate the safety & efficacy of efti + avelumab in patients (n=30) with metastatic urothelial cancer with the 1st patient expected to be enrolled & dosed in H1’23 & study to be held in Germany
  • Efti is a soluble LAG-3 candidate that is a first-in-class APC activator for the treatment of cancer. Additionally, efti was previously evaluated in the clinical trial (INSIGHT-004) in solid tumor patients

24. Akeso Out Licenses its Ivonescimab to Summit for ~$5B

Date - Dec 07, 2022                                                 

Product – Ivonescimab

  • Akeso to receive $500M up front, ~$4.5B in regulatory & commercial milestones making a total deal value of $5.0B along with royalties. Ivonescimab, known as AK112 in China & Australia and as SMT112 in the License Territories
  • Summit gets an exclusive right to develop & commercialize SMT112 in the US, Canada, EU, and Japan while Akeso gets the rights in the rest of the regions incl. China, leading the R&D expenses relating to Ivonescimab, incl. pre-clinical, safety & efficacy trials in non-licensed territories
  • Akeso is conducting 2 P-III trials of ivonescimab, one for NSCLC & second for EGFR-mutated advanced non-sq. NSCLC. Summit plans to start its clinical program in Q2’23 & announced a $500M rights offering & issuance of $520M in promissory notes

25. Janssen Presents P-III study (GLOW) Results of Imbruvica (ibrutinib) + Venetoclax for Chronic Lymphocytic Leukemia at ASH 2022

Date - Dec 12, 2022                                                 

Product – Imbruvica

  • The P-III study (GLOW) evaluating Imbruvica + venetoclax (I+V) vs chlorambucil + obinutuzumab (Clb+O) in a ratio (1:1) in 211 patients aged ≥65yrs. with CLL/SLL
  • The results showed a 79% reduction in risk of progression or death with a median follow-up of 46mos. & OS benefits were observed, 74.6% vs 24.8% were alive & progression-free before untreated older & comorbid @3.5yrs.; PFS was higher for uIGHV & mIGHV CLL & was sustained regardless of MRD status @3mos. along with robust efficacy with a superior & sustained PFS benefit
  • ≥90% estimated PFS for mIGHV CLL, independent of MRD status & 60% with uIGHV CLL who achieved undetectable MRD. The safety profile was consistent with known safety profiles of I+V

26. Takeda Entered into an Agreement to Acquire NDI-034858 from Nimbus Therapeutics for ~$6B

Date - Dec 14, 2022                                                  

Product – NDI-034858

  • Nimbus will receive $4B up front, ~$2B in commercial-related milestones upon achievement of annual net sales of $4B & $5B. The transaction is expected to be close before the end of 2022
  • The acquisition expands Takeda’s late-stage pipeline & therapeutic expertise in immune-mediated diseases. Nimbus will retain ownership of its other R&D subsidiaries
  • Takeda will lead the future development & commercialization of NDI-034858, an allosteric Tyk2 inhibitor that was developed by Nimbus & is being evaluated in P-IIb trials for multiple autoimmune diseases & other Tyk2 inhibitors. The P-IIb results are expected to present in early 2023 for PsO & the P-III trial of NDI-034858 is expected to be initiated in 2023 for psoriasis

27. Moderna and Merck Report P-IIb Study (KEYNOTE-942/mRNA-4157-P201) Results of mRNA-4157/V940 + Keytruda for Stage III/IV Melanoma

Date - Dec 14, 2022                                                 

Product – Keytruda

  • The P-IIb trial (KEYNOTE-942/mRNA-4157-P201) evaluates mRNA-4157/V940 + Keytruda (200mg, q3w for ~18 cycles) vs Keytruda alone in 157 patients with stage III/IV melanoma
  • The results showed a significant & clinical improvement in the 1EPs of RFS, 44% reduction in risk of recurrence or death. The AEs & safety profile was consistent with prior reported studies, and serious TRAEs were reported in (14.4% vs 10%)
  • The companies plan to discuss the results with regulatory authorities and also plan to initiate a P-III study in 2023. Under an agreement with Moderna, Merck had exercised its option to develop & commercialize mRNA-4157/V940 & both companies will share equal costs and profits

28. Dr. Reddy's Subsidiary Aurigene Stops Clinical Development of AUR-101 for the Treatment of Psoriasis

Date - Dec 19, 2022                                                  

Product - AUR-101                                                 

  • Dr. Reddy's subsidiary Aurigene decided to stop the clinical development of AUR-101 in the P-IIb trial (INDUS-3) in patients with mod. to sev. Psoriasis in the US
  • The decision was based on the P-IIb trial (INDUS-3) results which showed no desirable benefit to patients & the trial also failed to meet its 1EPs of PASI-75 @12wks. at 200mg, BID and the 400mg, QD while 1EPs was met at 400mg BID dose @12wks. over PBO
  • AUR-101 is a potent, oral RORϒt inverse agonist with high selectivity across other ROR isoforms & nuclear hormone receptors. Preclinical toxicology assessments of AUR-101 found it to be safe at several folds of effective human exposures & earlier clinical trials also demonstrated positive pharmacodynamic modulation

29. Anzac Animal Health’s Zycosan Receives the US FDA’s Approval as First Injectable

Date - Dec 21, 2022                                                  

Product - Zycosan                

  • The US FDA has approved Zycosan (pentosan polysulfate sodium inj.) that can help control the clinical signs & improve equine QoL for osteoarthritis in horses. Zycosan is sponsored by Anzac Animal Health
  • The sponsor of Zycosan conducted a field study on horses who had lameness in one leg and were found to have osteoarthritis in the lame leg. On Day 28, more horses in the Zycosan treated group had improved lameness grades over the control group and the study results indicated that treatment with Zycosan at the labeled dose benefited horses with single limb lameness due to osteoarthritis
  • Zycosan can be administered at a dose of 3mg/kg (1.4mg/lb) via intramuscular inj., qw for 4wks. in horses & is not for human use. The product is supplied in a 7.5ml single-use vial  

30. Everest Medicines Licensing Partner Pfizer Reports the US FDA and EMA’s Acceptance of NDA and MAA for Etrasimod in Ulcerative Colitis

Date - Dec 22, 2022                                                  

Product - Etrasimod              

  • The US FDA has accepted an NDA for review of etrasimod & EMA also accepted the MAA for active UC. The US FDA & EMA decision are expected in H2’23 & H1’24
  • The submissions were based on the P-III (ELEVATE UC 52 & 12) trials evaluating etrasimod (2mg, qd) vs PBO. Both trials met their 1EPs & 2EPs i.e., clinical remission (27.0% & 24.8% vs 7.4% & 15.2%) @12wks.; 32.1% vs 6.7% @52wk. in (ELEVATE UC 52) along with corticosteroid-free remission & sustained clinical remission @52wk.
  • Improvements in 2EPs incl. endoscopic improvement, symptomatic remission & mucosal healing @12 & 52wk. in (ELEVATE UC 52) & @12wk. in (ELEVATE UC 12) & the safety profile was consistent with prior studies. In (ELEVATE UC 12), similar patients experienced TEAEs while in (ELEVATE UC 52) it was higher in etrasimod

Related Post: PharmaShots' Key Highlights of Third Quarter 2022


Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at [email protected]

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