Little Cara steers through their first positive PhIII with a ‘breakthrough’ drug and a path to the FDA
Cara Therapeutics $CARA has successfully hit a key milestone in its push to get their lead drug across the finish line at the FDA. The biotech says it racked up a set of clearly positive data for their one drug, Korsuva (CR845), in their first Phase III trial readout for a severe itching condition among patients on hemodialysis. And if they can do it again in a confirmatory Phase III due out later in the year, they’ll be ready to beat a trail to regulators in search of an OK.
The data are solidly in its favor this time, with slightly more than half of the patients in the drug arm of the KALM-1 trial reporting an improvement in symptoms getting an injection of the drug, compared to 28% in the control arm. And there were some positive scores in a slate of secondaries that will stand in its favor, including itch scores and a quality of life measure. And researchers reported no significant safety issues that could hamper the drug, a kappa opioid receptor agonist.
That was good for a boost on the stock price, as shares jumped 18% on Wednesday morning.
The biotech is all-in on this one, with a range of clinical trials in the pipeline for Korsuva. Jefferies has pegged peak potential sales at a step up from the $500 million mark, and Jefferies analyst Mark Howerton has offered a few enthusiastic thumbs up along the way, looking past the initial IV formulation to oral drugs he believes has greater market potential for this indication.
CEO Derek Chalmers also said that investigators picked up signs of improvement after the first week, then running through the course of the 12-week program. Investigators recruited 350 patients with moderate to severe pruritis for this study.
Cara bagged bragging rights to the FDA’s breakthrough therapy designation 2 years ago, just days before the biotech took a hit on a failed pain trial they were running for this drug among patients with osteoarthritis. But they’ve successfully refocused investors on other sources of pain and pruritis as they continued to push ahead on this one drug.