Shilpa Medicare Achieves Milestone with Phase 1 Clinical Trial of sRbumin®

Shilpa Medicare Limited has successfully completed its Phase 1 clinical trial for sRbumin® - recombinant human albumin® 20%, making it the first Indian company to reach this milestone. The trial results indicate rHA's potential as a viable alternative to plasma-derived serum albumin, addressing global healthcare gaps. The product shows similar clinical benefits and safety profiles to its European counterparts.

In a significant development, Shilpa Medicare Limited (BSE: 530549) (NSE: SHILPAMED) has announced the successful conclusion of its Phase 1 clinical trial for sRbumin® - recombinant human albumin® 20% (rHA). This milestone makes Shilpa the first Indian company to achieve such a feat, highlighting rHA's promise as a viable alternative to plasma-derived human serum albumin.

The randomized, dose-escalating trial involved 62 healthy volunteers and aimed to evaluate rHA's safety, efficacy, and pharmacokinetics compared to European-sourced human serum albumin. Key findings revealed that rHA showed clinical benefits comparable to human-derived albumin, was generally well-tolerated, and exhibited similar bioavailability and immunogenicity profiles.

Human serum albumin is crucial for many medical treatments but is often in short supply due to reliance on blood donations. Shilpa's rHA, produced through yeast fermentation, offers a structurally and functionally equivalent alternative. With Phase 3 trials slated for Q4 FY25, Shilpa aims for product approval filings by FY26. The company's strategic clinical program targets expedited registration in Europe and emerging markets.

(With inputs from agencies.)