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Clinical Trial Data On Suven’s SUVN-502 Alzheimer’s Drug Delayed Till September

The much-awaited results of Suven Life Sciences’ phase 2A proof of concept (PoC) study for a new molecular entity SUVN-502 to treat Alzheimer’s, may not be unveiled till September 2019, sources told Moneycontrol.

Suven had planned to release the study’s top-line data at the Alzheimer’s Association International Conference (AAIC) in Los Angeles on July 17, but this has now been delayed due to technical reasons, the company said.

The company, which is engaged in Contract Research and Manufacturing Services (CRAMS) and Specialty Chemicals, is betting big on SUVN-502, generically called Masupirdine.

Suven has invested more than $100 million on research and development (R&D), a significant portion of which was spent on SUVN-502’s PoC trial that began in 2015.

The study’s success will boost the company’s chances of getting an out-licensing partner, to take the drug into a much larger phase-3 clinical trial.

Suven will be able to monetise the asset through upfront and milestone payments, and if the drug moves beyond clinical and gets approved, the company will get royalties on sales.

Failure, however, would mean the entire clinical trial expenditure would go down the drain, and the drug will be shelved.

As part of the PoC study, Suven tested the drug on 563 patients in the US, aged between 50-80 years, and being treated with Aricept (donepezil) and Namenda (memantine). The trail was multi-centre, randomised, double-blind and placebo-controlled.

This is the first-ever study to evaluate a triple combination therapy for moderate Alzheimer’s patients.

High failure rate

Alzheimer’s is a degenerative brain disease that afflicts 46 million people in the world, with not many treatment options for patients. SUVN-502’s clinical trial data assumed significance as no new Alzheimer’s drug has been approved since Forest Labs’ Namenda 2003.

The development of Alzheimer’s drugs has been marred by a high failure rate. Two previous high-profile failures were in the 5-HT6 antagonist class, in which Suven’s drug also belongs.

A 5-HT6 antagonist works by boosting acetylcholine, a neurotransmitter needed for normal cognition.

Danish biotech firm Lundbeck and US-based biotech startup Axovant had to give up on their molecules in the phase-3 trial as the data failed to show meaningful efficacy on patients.

Venkat Jasti, Suven’s Founder and Chief Executive Officer told Moneycontrol that he is confident of his drug crossing the line, as his molecule is better than others.

Meanwhile, Suven is trying to underplay SUVN-502’s outcome.

The company has reiterated that its future is not dependent on the outcome of SUVN-502, as it has a thriving CRAMS business that is growing at 15-20 percent with healthy operating profit margins. – Money Control

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