Over the last few weeks, tiny LA-based Ritter Pharmaceuticals $RTTR has changed the primary endpoint and recalculated the data for its critical Phase IIb/III study of its sole clinical asset. But on Tuesday evening the cash-strapped nanocap biotech declared a win, triggering a (temporary) surge in its stock price.
If you look at all 368 patients in the study, says Ritter, the top-line results found a 40% response for its lactose intolerance drug RP-G28 and a 31% response for the placebo arm. That was not statistically significant. But…
Ritter says it found “significant irregularities” in one of the trial sites, excluded that group from the statistical analysis and came up with its headline win, claiming that the drug hit the mark at the primary endpoint. And the primary endpoint was changed, as the virtual biotech noted in an SEC filing March 1, after the study was complete.
By addressing the FDA’s recent recommendations, the Company has chosen to modify aspects of its SAP, including modifying its primary endpoint to combine abdominal pain with relevant secondary endpoints to establish an abdominal composite score (abdominal pain, abdominal cramping, abdominal bloating and abdominal gas). The protocol design and the assessment utilized to collect lactose intolerance symptoms remain unchanged.
All it needs now, says Ritter, is a confirmatory Phase III and they should be good to go with a new drug application.
“The results put us one step closer to developing the first FDA approved treatment for lactose intolerance, a significant condition of unmet need suffered by over 40 million in the U.S. and millions more worldwide,” noted company founder Andrew Ritter.
According to the company’s 10-K, Ritter ended 2016 with $7 million in reserves. That’s about half of what it spent on R&D the same year. The company has seven employees, according to the SEC filing, and Ritter earned $931,584 in total compensation.
Ritter started this morning with a market cap of only $22 million. Its shares were on the rise this morning, but dipped into the red by mid-day and ended down 18%. As Ritter’s 10-K also notes, all the companies eggs are in this one basket. The biotech’s success or failure rests on the data.
The best place to read Endpoints News? In your inbox.
Full-text daily reports for those who discover, develop, and market drugs. Join 21,000+ biopharma pros who read Endpoints News by email every day.Free Subscription