Two months ago shares of Cara Therapeutics tanked on the news that the FDA had slapped a clinical hold on its late-stage study of a new painkiller. And today the stock bounced back up after the agency took its foot off the brakes, satisfied that the trial can safely resume.
The safety scare was prompted by signs of high sodium levels in the blood of the first 90 patients participating in the study. Those levels, the Shelton, CT-based biotech found, “were dose-dependent and asymptomatic with the lowest frequency of events found in the 1 ug/kg I.V. CR845 group. Based on this safety review and an analysis of efficacy trends, the study will continue as a three-arm trial testing two doses of CR845 (1 ug/kg and 0.5 ug/kg) versus placebo.”
And the biotech’s CEO says that they also have some efficacy data to back up its dose selections.
"Our unblinded analysis of the initial cohort of patients has identified interim efficacy signals for pain, supplemental opioid use and opioid-related side effects that support our dose selections,” said Cara CEO said Derek Chalmers. “We look forward to continuing patient recruitment next month and to providing further updates on our progress later this year.”
Cara’s stock jumped 8% on the news in premarket trading Wednesday morning.
Cara pulled off a $55 million IPO back in 2014 largely on the promise of CR845, a "peripherally active" kappa opioid analgesic that bypasses the central nervous system, binding to nerve cells in a way that is designed to block pain at the source without the drug high--or other side effects like vomiting--that has spurred legions of abuse cases for mu opioid drugs such as morphine, fentanyl and hydromorphone.
The trial will enroll up to 450 patients.
- here's the release