Shilpa Medicare Completes Phase 1 Trial For rHA

Shilpa Medicare Completes Phase 1 Trial For rHA

By, Admin 31 August 2024

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.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!