It’s incredibly difficult to bring a new pharmaceutical drug to market: about 95% of drugs in clinical trials never get approval. For Alzheimer’s disease, that percentage changes to 99%.
But Vivek Ramaswamy, a 29-year-old former Wall Street hedge fund manager, told investors at a meeting Wednesday that his company Axovant is “a single confirmatory study away” from getting FDA approval for his mild-to-moderate Alzheimer’s disease treatment, currently called RVT-101.
Pharmaceutical giant GlaxoSmithKline started developing the drug, but couldn’t get it off their hands fast enough — it had done poorly on its own in clinical trials. That is, except one, which combined the drug with Aricept, a widely used drug already available on the market and used to treat Alzheimer’s symptoms like memory loss and confusion. Together, the two together slowed the loss of cognition and ability to perform daily tasks than when Aricept was taken alone.
Ramswamy latched on to that one study. Axovant got the rights to the compound in December 2014, paying only $US5 million for it. Since then, the company had its initial public offering in June — the biggest in biotech history at $US1.4 billion, according to Forbes.
It plans to launch the phase 3 trial by the end of the year, building off the results of its recent phase 2b study which were announced earlier this week.
Axovant is in the business of late-stage drug development, which means they don’t research and develop their own drugs from scratch. This cuts years off the costly drug development process.
The phase 3 study will again use Aricept, generically known donepezil. The hope is to make RVT-101 a pill that’s taken once a day.
But it’s not out of the woods yet. Just because a study has success up through phase 2b does not mean the FDA is ready to hand over approval. But doctors have shown support for the drug. It’s not a huge medical advance, but it is a step in the right direction. Ramswamy said in a meeting with investors they hope to file for FDA approval by 2017.
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