Oral CR845 for treating chronic kidney disease–associated pruritus
In July 2017, Cara Therapeutics (CARA) announced the results from a Phase 1 safety and pharmacokinetics study of oral CR845 in patients with chronic kidney disease (or CKD) undergoing hemodialysis. The results showed that the four dosage strengths evaluated in the study were well tolerated.
In October 2017, the company initiated a Phase 1 trial of oral CR845 in patients with Stage 3–5 CKD. The trial is designed to examine the pharmacokinetics and safety of three dosage strengths of oral CR845. The company hopes that the data from this trial will help in the dose selection and design of a placebo-controlled Phase 2 trial of oral CR845 in patients with Stage 3 CKD, which Cara Therapeutics plans to begin in 1Q18.
Oral CR845 for the treatment of chronic liver disease–associated pruritus
Cara Therapeutics plans to submit an investigational new drug application for oral CR845 for the relief of CLD-aP (chronic liver disease–associated pruritis) symptoms in 4Q17. CLD-aP manifests as cholestasis symptoms causing severe whole-body itch. This condition disrupts patients’ daily activities and sleep, affecting their quality of life.
Cara Therapeutics entered into an agreement with Maruishi Pharmaceutical in April 2013, under which the former granted the latter an exclusive license to develop, manufacture, and commercialize products containing CR845 for acute pain and uremic pruritus in Japan.
In March 2017, Maruishi sub-licensed CR845 development and sales to Kissei Pharmaceutical for treating uremic pruritus in dialysis patients in Japan. Consequently, Cara Therapeutics recorded revenue of $843,000 from Maruishi.
For a clinical stage company, the availability of sufficient cash is paramount. While Cara Therapeutics’ cash-per-share ratio stands at 3.3, peers Aquinox Pharmaceuticals (AQXP), Flexion Therapeutics (FLXN), and Neurocrine Biosciences (NBIX) have ratios of 5.1, 9.2, and 5.8, respectively. Cara Therapeutics makes up ~0.02% of the iShares Russell 2000 ETF (IWM).