Pain Drug Company Cara Therapeutics Poised to Have a Big Launch… Maybe
December 21, 2016
By Mark Terry, BioSpace.com Breaking News Staff
With 2016 being a relatively down year for biotech stocks, many investors and analysts are scanning around for the occasional bright light or undervalued company likely to take off in the upcoming year. Jim Crumly, writing for The Motley Fool, takes a look at Cara Therapeutics , which has taken a battering, but seems to be poised on the launching pad for a terrific takeoff.
Cara Therapeutics focuses on developing therapeutics for pain, inflammation and pruritus. It is also one of only a handful of companies in the U.S. developing Cannabinoid-based drugs, although its lead product is not a Cannabinoid-based therapeutic.
The company’s lead drug is CR845, which is in clinical trials for three different indications. It is being evaluated intravenously for post-operative pain, orally for chronic pain, and for pruritus, a chronic systematic itching that affects patients with chronic kidney disease. There are no approved therapies for pruritis in the U.S.
On November 29, Cara announced that it had completed patient enrollment for its multi-dose adaptive Phase II/III clinical trial of IV CR845 in dialysis patients with moderate-to-severe uremic pruritus (UP). It expects to announce topline data from Part A of the trial in the first quarter of 2017, and hopes to start a registration phase later in the year.
All three indications have large markets. For the post-operative pain indication, there are 46 million inpatient and 53 million outpatient surgeries performed each year in the U.S. that require treatment. For the chronic pain market, in the U.S. alone there are about 100 million prescriptions made annually. For pruritus, about 60 percent of dialysis patients report it, an estimated market of about 20 million patients in the U.S.
Crumly writes, “Despite the significant progress, the market capitalization of the company stands at $251 million today, down 11 percent since its IPO. The market has been wary of biotech stocks in general in 2016, but there was a specific concern about Cara early in the year when the trial of IV CR845 for pain was halted due to elevated blood sodium levels in some subjects. It turned out the condition was not severe enough to be dangerous and could easily be prevented by lowering the dosage. But the stock remains less than half of what it was at the peak around the first successful Phase II trial last year.”
Nonetheless, if there’s a positive readout for any of these indications, the stock could take off. The part A of the pruritis trial will be in the next three months or so, the data from the Phase IIb of oral CR845 is expected in the first half of 2017, and the IV CR845 for post-operative pain is expected by the end of next year.
At this point, CR845 is the only drug Cara has in the clinic, so it’s a big bet. And the company is fighting the clock. Its cash burn is typically under $15 million per quarter, and it has $71 million in cash and cash equivalents, but money goes fast in late-stage trials because they typically increase the number of patients in the trial. The company has indicated it only has enough money to carry it through the first quarter of 2018.
Crumly writes, “Cara Therapeutics is a one-trick pony at this point, but that horse appears to be a thoroughbred in a race for a huge purse. With significant late-stage trial results coming out in 2017, this next year is pivotal for the company.”
