Shilpa Medicare's US Customer Gets Fast Track Approval For Glioblastoma Drug
Shilpa Medicare's drug is presently undergoing a Phase 1A clinical trial to test its safety and how well it is tolerated in various solid tumors, including GBM.
Shilpa Medicare Ltd.'s US-based CDMO customer has received fast track designation for its drug to treat Glioblastoma or GBM by the US FDA.
The drug is presently undergoing a Phase 1A clinical trial to test its safety and how well it is tolerated in various solid tumours, including GBM, according to an exchange filing on Wednesday. They also plan to start its phase 1b/2a trial for recurrent GBM in late 2024 or early 2025.
GBM affects approximately 13,000 people each year in the US and around 3,00,000 worldwide, with a very high mortality rate of 94%, the filing said.
The usual treatments for GBM only extends the life expectancy to less than 15 months.
One big challenge in developing new drugs for GBM is that they must be able to cross the blood-brain barrier and also overcome the natural resistance of GBM cancer cells to existing treatments, according to the filing.
Shilpa Medicare has partnered with its CDMO customer to offer a solution for developing the active pharmaceutical ingredient or API and formulation for this challenging drug, which hasn’t had a new treatment option in over 20 years.
The pharma firm, along with its wholly owned subsidiary Shilpa Pharma Lifesciences Ltd., has already produced the developmental quantities and is now focused on GMP-grade material, said the filing.
Shares of Shilpa Medicare closed 0.17% higher at Rs 887.30 apiece, compared to a 0.34% fall in the benchmark NSE Nifty.
The stock has risen 162.17% in the last 12 months and 168.63% year-to-date.
The two analysts tracking the company suggest a 'buy', according to Bloomberg data. The average 12-month analysts' consensus price target implies an upside of 23.5%.
