AltruBio Receives the US FDA’s IND Clearance to Initiate a P-II Clinical Trial of ALTB-268 for Ulcerative Colitis
Shots:
- The US FDA has cleared an IND application to initiate a P-II clinical study that consists of an open-label exploratory biomarker clinical trial of ALTB-268 in patients with ulcerative colitis. The exploratory biomarker study is expected to initiate at the end of 2023 while patient enrolment in the randomized study is expected in 2024
- The P-I study evaluating the safety and tolerability of ALTB-268 in healthy volunteers showed no serious AEs across all cohorts
- ALTB-268, a tetravalent PSGL-1 agonist Ab that acts as an immune checkpoint enhancer. The P-II study results of ALTB-168 for UC, psoriasis, PsA, and SR/TR-aGVHD showed improved patient outcomes and clinically meaningful efficacy
Ref: Globe Newswire | Image: Altrubio
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