Mumbai: Once bitten twice shy? Not in the case of Venkat Jasti, chairman and CEO of Suven Life Sciences, who is gearing up to conduct Phase-3 clinical trials of a potential therapy against Alzheimer’s disease despite its partial failure in Phase-2 study.
Masupirdine, or SUVN-502, developed as a potential therapy against Alzheimer’s disease and dementia, failed to meet primary end point after enrolling 564 patients in Phase 2 proof-of-concept trial in the US, as the company announced in November 2019.
But that has not deterred Jasti. He pumped ₹400 crore into Suven Life Sciences in the form of a rights issue in November 2022 to fund the Phase-3 trial of the therapy that “has demonstrated a great safety profile”.
“Based on the promising secondary end point and safety profile and with the discussion with USFDA (US Food and Drug Administration), we will move this compound into Phase-3 clinical trial targeting agitation and aggression in Alzheimer type dementia and are initiating this Phase-3 study in North America and Europe,” Jasti told ET in an interview.
Suven Life Sciences is also backing another molecule, SUVN-G3031 (Samelisant), which is undergoing Phase-2 study on narcolepsy (a chronic sleep disorder) in North America. Trials of this molecule have gained momentum after a temporary slowdown owing to the pandemic, Jasti said.
The funding to keep his drug discovery pursuits alive may not be a problem, as Jasti in December last year sold his profitable contract development and manufacturing services (CDMO) venture Suven Pharmaceuticals to private equity firm Advent International for ₹6,313 crore.
Jasti said developing new therapies for neuro-degenerative diseases like Alzheimer’s and dementia have been challenging.
“In oncology, promising data from an early stage trial could guarantee funding from partners, but it isn’t the same case for Alzheimer’s… So, we have to fund the trials on our own,” he said.
Beyond his drug discovery pursuit, Jasti said he hasn’t yet to make up his mind on what to do with the fortune he made through the sale of CDMO business.
Alzheimer’s drug has been marred by a failure rate as high as 95% in clinical trials.
Credits – Source – https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/suven-life-sciences-breathes-new-life-into-drug-discovery-plans/articleshow/98554309.cms