Shilpa Medicare completes phase 1 trial for rHA for volume replacement therapy for accidents, burns, and surgeries
Overview
Shilpa Medicare has successfully completed of its phase 1 clinical trial for its flagship product, sRbumin a recombinant human albumin 20% (rHA). Human serum albumin is essential for various medical treatments, such as volume replacement therapy for accidents, burns, and surgeries.
The Raichur-based company offers APIs, formulations, and biologics, with facilities approved by major regulatory agencies. The company is also recognized for providing complete turnkey CDMO solutions for clients globally.
Phase 1 Clinical Study
- The positive results underscore rHA's potential as a viable alternative to plasma-derived human serum albumin, addressing a critical gap in global healthcare.
- The phase 1 clinical study was a randomized, dose-escalating, comparative trial against European-sourced human-derived serum albumin, involving 62 healthy volunteers.
- It aimed to evaluate the safety, efficacy, and pharmacokinetics of rHA at different dose levels.
- In fact the company said that it is the first Indian pharma enterprise to achieve this milestone.
Shilpa Medicare CMD onPhase-3 Studies
- From here we will be starting phase-3 studies and also meantime approach different regulatory agencies for taking opinion on our clinical study protocol.
- It took us more than 5 years to develop this. It will help us qualify at different excipient grade end consumers. The fruitful outcome of the phase I study acts like a testimonial for our company in terms of development of a new biological entity from animal stage to commercial stage and also developing a complex molecule like Albumin. We are hopeful for more new opportunities, Vishnukanth Bhutada, CMD, Shilpa Medicare told Pharmabiz.
Phase I Study Outcomes
- Findings from the phase I indicated that rHA demonstrated clinical benefits comparable to human-derived albumin in surrogate endpoints such as colloidal osmotic pressure and haematocrit ratio.
- In terms of safety it was generally well-tolerated, with no serious adverse events reported.
- There was also no significant difference observed in the incidence of anti-drug antibodies compared to human-derived albumin.
- The bioavailability was comparable to human albumin, said the company.
Shilpa Medicare CMD’s Words
- However, the current supply of rHA is heavily dependent on blood donations, leading to potential shortages.
- Shilpa's rHA, produced using yeast fermentation, offers a highly purified, structurally and functionally equivalent alternative, he added.
- We are thrilled with the positive outcomes of our Phase 1 clinical trial and this success brings us closer to providing a safe and reliable alternative to human serum albumin, easing global supply concerns, said Bhutada.
Shilpa Medicare
- Set up in 1987, Shilpa Medicare is strategically positioned to expedite rHA's development.
- The carefully designed clinical programme, with comparisons to a proven European product, aims to streamline registration processes in Europe and emerging markets, promising a faster path to market for this critical, often-scarce product, said the company.
Initiation of Phase III Trial
- Building on this success, Shilpa Medicare plans to initiate phase 3 clinical trials for rHA by Q4 FY25.
- These trials are expected to be completed within a year, followed by product approval filings in FY26, said Bhutada.
