The research team at Centrexion Therapeutics, a Boston-based biotech startup led by ex-Pfizer CEO Jeffrey Kindler, turned up at a scientific conference in Europe to spell out their Phase IIb data for a new pain drug the company is developing for osteoarthritis.
Their lead drug is CNTX-4975, which targets the TRPV1 receptor and is aimed at deactivating pain fibers that send pain signals from the knee straight to the brain. That way a single shot should work for six months out, until the fibers regenerate to start flashing those signals again.
According to investigators, they came up with a clean hit on primary and secondary endpoints on two pain measures that showed a clear separation from a placebo after 12 weeks. One of the endpoints also achieved statistical significance at 24 weeks, though the other scored a p-value of 0.064, which falls short, though the company “predetermined” its statistical significance at with a bar of 0.1.
I’ve asked I asked for a clarification on that and this is what I heard back:
Sometimes, teams will use a larger p value (alpha) to identify what is statically significant, as long as it is pre-specified in the protocol. Of note, Phase 3 trials require a p value of <=0.5, as it is a regulatory requirement for filing. Since this was a relatively small OA pain trial, we pre-specified the alpha of 0.1.
Since the p value of 0.1 was pre-specified, it is statistically and scientifically correct to say we had statistical significance with a p value of 0.067 at week 24. Additionally, this was the MMRM analysis, which was a secondary/sensitivity analysis. The primary analysis was the AUC, which had a p value at 12 weeks of <0.0001, and at 24 weeks was p= 0.0002.
“We start seeing a statistical separation at one week and throughout 12 weeks of the endpoints,” Centrexion CMO Randall Stevens told me late last year when the company reviewed the trial results for the first time. “When you look at 24 weeks, we still see a statistical separation at 24 weeks.”
“With these positive data and the successful End of Phase II meetings with the FDA and the European authorities that we had earlier this year, we look forward to advancing the development of CNTX-4975 with the initiation of a Phase III trial for the treatment of chronic moderate to severe knee osteoarthritis pain later this year,” said Kindler in a statement.
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