Breakthrough in Recombinant Human Albumin
Shilpa Medicare Limited has announced a landmark achievement with the successful completion of its Phase 1 clinical trial for sRbumin® – recombinant human albumin® 20% (rHA). This accomplishment makes Shilpa Medicare the first Indian company to reach this significant milestone, positioning rHA as a promising alternative to plasma-derived human serum albumin.
Highlights from the Phase 1 Trial Results
The Phase 1 clinical trial was a randomized, dose-escalating, comparative study involving 62 healthy volunteers. The primary goal was to assess the safety, efficacy, and pharmacokinetics of rHA at varying dose levels in comparison to European-sourced human-derived serum albumin.
Findings from the Trial:
- Clinical Benefits: The results demonstrated that rHA provided clinical benefits comparable to human-derived albumin. This was evident in surrogate endpoints such as colloidal osmotic pressure and hematocrit ratio, suggesting that rHA can effectively replicate the functional properties of traditional human serum albumin.
- Safety Profile: rHA was generally well-tolerated among participants, with no serious adverse events reported. This favourable safety profile supports the potential for its use in broader clinical applications.
- Immunogenicity: The incidence of anti-drug antibodies was similar between rHA and human-derived albumin, indicating that rHA does not elicit an immune response that could impair its effectiveness.
- Bioavailability: The bioavailability of rHA was found to be on par with that of human albumin, confirming that the recombinant product performs similarly in the body to its natural counterpart.
Addressing Global Healthcare Challenges
Human serum albumin is a critical component in various medical treatments, including volume replacement therapy for trauma, burns, and surgeries. The current supply heavily depends on blood donations, which can lead to shortages and supply chain issues. Shilpa Medicare’s rHA, produced through advanced yeast fermentation, offers a highly purified and structurally equivalent alternative. This development is crucial for mitigating global supply constraints and ensuring the availability of this essential therapeutic product.
Future Impact and Innovations
The successful trial of rHA is expected to catalyse further innovations in the field of biopharmaceuticals, potentially setting new standards for recombinant protein therapies. Shilpa Medicare’s approach not only addresses a critical supply issue but also paves the way for future advancements in biosimilar products.
The company’s ongoing research aims to explore additional therapeutic applications for rHA beyond volume replacement, potentially extending its use to other areas of critical care. This could include applications in liver diseases and autoimmune conditions, broadening the therapeutic landscape for recombinant albumins.
Furthermore, Shilpa Medicare plans to leverage insights from the Phase 1 trial to optimise future clinical development phases. The data will guide improvements in formulation and administration, ensuring that rHA meets the highest standards of efficacy and safety in diverse patient populations.
Mr. Vishnukant Bhutada, Managing Director of Shilpa Medicare, commented on the success: “We are extremely pleased with the outcomes of our Phase 1 clinical trial of sRbumin® – recombinant human albumin 20%. This milestone is a significant step toward providing a safe and reliable alternative to human serum albumin, addressing critical global supply concerns.”
Next Steps and Future Directions
The success of this trial positions Shilpa Medicare to progress swiftly with the next phases of rHA development. The company’s clinical program is strategically designed to facilitate comparisons with established European products, streamlining the registration process in Europe and emerging markets. This approach is anticipated to expedite the product’s path to market.
Shilpa Medicare aims to commence Phase 3 clinical trials for rHA by the fourth quarter of FY25. These trials are expected to be completed within a year, with product approval filings projected for FY26. This progression marks a pivotal moment in Shilpa Medicare’s mission to expand its product offerings and address global healthcare needs effectively.
