Shares of Shilpa Medicare soared up to 7.96 per cent at Rs 718.90 per share on the BSE in Wednesday’s intraday deals. This came after the company announced that it has successfully completed its phase one clinical trial for recombinant human albumin 20 per cent (rHA).
“The positive results from this trial mark a significant milestone in the development of rHA, demonstrating its potential as a viable alternative to plasma derived human serum albumin,” the company said in an exchange filing.
The randomised phase 1 clinical study involved 62 healthy volunteers. The trial aimed to evaluate the safety, efficacy, and pharmacokinetics of rHA at different dose levels.
Among the key findings of the phase one trial was that rHA demonstrated clinical benefits through surrogate endpoints such as colloidal osmotic pressure and hematocrit ratio, comparable to human-derived albumin.
Further, the safety profile of rHA was favourable, with no serious adverse events reported. Additionally, the incidence of anti-drug antibodies was similar to that seen with human-derived albumin, indicating no significant immunogenicity concerns. rHA also showed comparable bioavailability to human albumin, further supporting its potential as a viable alternative, the company said.
Albumin is in high demand for various medical treatments, including restoring blood volume and replacing lost fluids during accidents, serious burn injuries, foetal erythroblastosis, hypoproteinemia, and surgeries.
Albumins are transport proteins that carry various substances in the body. Human serum albumin, the main protein in human blood plasma, makes up about 50 per cent of plasma proteins. It helps transport water, minerals (like calcium, sodium, and potassium), fatty acids, hormones, bilirubin, thyroid hormone (T4), and certain medicines (including barbiturates).
The market capitalisation of Shilpa Medicare is Rs 6,950 crore, according to the BSE. At 12:57 PM; the shares of the company were trading 6.74 per cent higher at Rs 710.75 a piece. By comparison, the BSE Sensex surged by 0.77 per cent to 79,200 levels.
Shilpa Medicare is a manufacturer of APIs and formulations, with significant expertise in oncology. It supplies over 30 oncology APIs to various regulated markets, including the USA, Europe, Japan, South Korea, Russia, Mexico, Brazil, and other emerging markets.
First Published: Aug 07 2024 | 2:19 PM IST
