FDA, Results

PhIII-focused Cara sees shares spike on its new ‘breakthrough’ status at the FDA

Derek Chalmers, CEO, Cara

Cara Therapeutics $CARA has been through it all with their leading, late-stage program for IV CR845, a pain therapy that inspired an IPO, a swooning stock price when the IPO bubble burst and then a short, painful crash when the FDA dropped a clinical hold on it in early 2016.

That hold, though, was lifted two months later and this morning Cara saw its share price spike 16% on the FDA’s award of its breakthrough therapy designation for a painful itching condition called uremic pruritis in chronic kidney disease patients.

The drug scored a 68% drop in average itching scores in the first part of its Phase II/III study, which regulators felt justified an open door invitation to help the company through Phase III. The secondary on that saw a 100% improvement in quality of life scores, which also attracted the FDA’s attention.

Regulators should now be on hand as Cara completes the recruitment of 240 patients for the Phase III portion of the trial.

“The FDA’s decision to grant Breakthrough Therapy designation is recognition of both the significant unmet medical need among CKD patients with UP and the potential of I.V. CR845 to address it,” said Cara CEO Derek Chalmers in a prepared statement. “We have already initiated our Phase III program and look forward to working closely with the FDA to bring this potential new treatment option to hemodialysis patients as quickly as possible.”


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