Suven Life Sciences, on November 30, said its drug candidate SUVN-502 targeting Alzheimer's Disease (AD) failed to meet its pre-specified primary endpoint in proof of concept (PoC) phase two study.
As part of the PoC study, Suven tested the drug as triple combination with Aricept (donepezil) and Namenda (memantine) on 563 patients in the US, aged between 50 and 80 years. The trial 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.
"We are very disappointed with the outcome of this trial," Venkat Jasti, CEO of Suven, said.
"But the findings present an important step forward in further exploration of the potential therapeutic effects of Masupirdine (SUVN-502) in Alzheimer's Disease (AD) and Behavioral & Psychological Symptoms in Dementia (BPSD)," Jasti added.
Jasti said the company will work with regulators and potential partnering companies in the design and conduct of future studies for further exploration of the potential of Masupirdine (SUVN-502).
The unique triple-therapy (Masupirdine + Donepezil + Memantine) design was based on efficacy results in pre-clinical cognition models in which masupirdine enhances the effects of combined treatment with Donepezil and Memantine.
The PoC trial also established that Masupirdine (SUVN-502) is safe and well tolerated without significant adverse events.
Subgroup analyses on cognition, function, behavioural, neuropsychiatric inventory and secondary endpoints revealed interesting, statistically significant and potentially beneficial data sets, the company said.
The study findings will be presented at Clinical Trials on Alzheimer's Disease (CTAD) being held at San Diego from December 4-7.
Huge setback
For Suven, with revenues of Rs 687.7 crore (less than $100 million) in FY19, that is engaged in Contract Research and Manufacturing Services (CRAMS) and Specialty Chemicals, SUVN-502, was a huge bet.
The company had spent about $100 million on research and development (R&D), of which around one-fourth was on SUVN-502's PoC trial that began in 2015.
The success of the PoC trial would have boosted the company’s chances of monetising the drug by out-licensing it to a partner, who would have shared the risk of taking the drug into a much larger phase-three clinical trial.
Alzheimer's is a degenerative brain disease that afflicts 46 million people in the world, with not many treatment options available for patients.
SUVN-502's clinical trial data assumed significance as no new Alzheimer's drug has been approved since Forest Labs' Namenda in 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-three trial as the data failed to show meaningful efficacy on patients.
Meanwhile, Suven is underplaying SUVN-502's outcome. The company had earlier said 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.
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