Cara Therapeutics seeks FDA approval for drug for kidney-disease patients

STAMFORD — Biotech firm Cara Therapeutics has submitted its first new drug application to the federal Food & Drug Administration for an injectable treatment for the itch condition pruritus, the Stamford-based company announced Monday.

Korsuva would treat moderate to severe pruritus in patients with chronic kidney disease who are undergoing hemodialysis. Stamford-based Cara has requested a “priority” review for the application — which, if granted, could result in a six-month evaluation process.

A “breakthrough therapy designation” that the FDA gave to the drug in 2017 paved the way for the company to seek the expedited assessment.

“The NDA submission for Korsuva injection marks a significant milestone for Cara and for hemodialysis patients who suffer from intractable pruritus,” Cara CEO and President Derek Chalmers said in a statement. “I’d like to thank the entire Cara team for working tirelessly to bring this first-in-class therapeutic from in-house discovery, through development to the completion of NDA submission, as well as the patients, investigators and site personnel who participated in the clinical trials.”

The FDA has 60 days to determine whether the submission is complete and acceptable for filing, the company said in an announcement.

If it gains FDA approval, Korsuva’s injectable form would be Cara’s first drug to go on the market.

Cara officials have said that they are aiming for a 2021 commercial launch.

An oral form of Korsuva is also in the pipeline, with phase-three clinical trials scheduled for next year.

Between 23 million and 38 million Americans are estimated to suffer from chronic pruritus, according to a 2015 study.

In preparation for the Korsuva injection’s rollout, Cara recently signed a deal with Vifor Pharma for its commercialization across the entire U.S. dialysis market.

Through the agreement, Cara will receive a 60 percent share of the medicine’s profits, an upfront payment of $100 million and an equity investment of $50 million.

For Cara, the new agreement built on a 2018 international licensing deal for the Korsuva injection that Cara signed with Vifor Fresenius Medical Care Renal Pharma Ltd., a joint company of Vifor and Fresenius Medical Care that specializes in treatments for chronic kidney disease.

“This (deal) will support our long-term strategy of developing the oral tablet form of Korsuva, which is designed to treat pruritus across a broad range of patients where chronic pruritus is still a significant unmet need,” Chalmers said in a recent interview. “That includes dermatological patient populations such as (those with) atopic dermatitis, as well as earlystage chronic kidney disease-associated pruritus. Those are all very large patient populations.”

In the past few years, Cara had several hundred million dollars to support its research and development.

Last year, Cara issued about $146 million of stock, following offerings of $98 million in 2018 and $92 million in 2017. The company held its initial public offering in 2014.

“As a biotech company, we’re always looking for effective ways to build capital and bolster our balance sheets, so we can support all of our development programs,” Chalmers said. “This new license agreement does that … and extends our cash ‘runway’ all the way to 2023, which is well into when we expect profit-sharing revenue from this particular license agreement.”

Cara employs about 75 workers. Its main offices are located at 107 Elm St. in downtown Stamford.