Cara Therapeutics tried to spin the data in its favor, but all three doses of its lead drug CR845 flopped against a key endpoint on pain for osteoarthritis, including the high dose, leaving investigators trying to polish up other data sets as an indication of success.
The important data set that did work out was for patients with osteoarthritis of the hip who completed an 8-week course of the high 5 mg dose. But even that was not a home run, with a p-value on pain reduction of 0.043 compared to the placebo arm. For all OA hip and knee patients who completed high-dose therapy there was a failed p-value of 0.111.
Neither the 1 mg or 2.5 mg doses proved effective in significantly reducing pain.
Stamford, CT-based Cara’s shares $CARA plunged 30% on the news on the Phase IIb catalyst — which recruited 476 patients — despite some heavy lifting in the spin zone.
For patients maintained on the 5 mg dose, the company said, “there was a statistically significant increase in the proportion of patients whose OA was “very much improved” or “much improved” as indicated by Patient Global Assessment score in both the total patient group (p <0.005 vs. placebo) and in patients with primary OA of the hip (p<0.006 vs. placebo).” And investigators vowed that they had learned plenty in preparation for their next study of this drug.
“Developing effective analgesics that lack the high abuse potential and serious side effects of currently available drug classes remains the most pressing need in chronic pain,” said Dr. Ajay D. Wasan, University of Pittsburgh Medical Center (UPMC). “The magnitude of the reduction in mean joint pain scores observed in all patients in this trial together with an encouraging safety profile underscores the significant potential of CR845 as a new therapeutic approach for the treatment of chronic inflammatory pain.”
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