Kashiv BioSciences Reports the First Patient Enrolment of ADL018 (biosimilar, omalizumab) in the P-III Clinical Study for Chronic Spontaneous Urticaria
Shots:
- The first patient has been enrolled in the P-III study of ADL018 vs Xolair in patients with chronic idiopathic/spontaneous urticaria (CSU) who remain symptomatic on H1 antihistamine treatment. Additionally, ~600 patients are expected to enroll globally in sites across the US, EU & India
- The trial focuses on comparing ADL018 & Xolair in terms of efficacy, safety, tolerability & immunogenicity. ADL018, a humanized mAb that inhibits the binding of IgE to the high-affinity IgE receptor (FcεRI) on the surface of mast cells and basophils & is being developed as a biosimilar candidate to Xolair (omalizumab)
- Omalizumab was approved for persistent asthma in patients aged ≥6yrs. & chronic rhinosinusitis with nasal polyps in patients aged ≥18yrs.
Ref: Businesswire | Image: Kashiv
Related Post:- Amneal & Kashiv Receive the US FDA’s Approval for Fylnetra (biosimilar, pegfilgrastim)
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