Stamford Advocate

‘A very important drug’

Cara Therapeuti­cs gains FDA approval for itching treatment

- By Paul Schott

STAMFORD — Biotech firm Cara Therapeuti­cs announced this week it had gained the Food & Drug Administra­tion’s approval for an injectable treatment for moderate to severe forms of the itch condition pruritus in chronic kidney disease patients — paving the way for the Stamfordba­sed company’s first drug to go on the market.

Officials at Stamfordba­sed Cara hailed the green light for the Korsuva injection, which they describe as the first and only therapy approved by the FDA for pruritus associated with chronic kidney disease in adults undergoing hemodialys­is. Having secured the agency’s backing, Cara officials are anticipati­ng the drug’s promotiona­l launch in the U.S. in the first quarter of 2022.

“I think the FDA has recognized this is a very important drug,” Cara CEO and President Derek Chalmers said in an interview Tuesday. “We’re very pleased.”

Extremely itchy skin is a common symptom of advanced kidney disease, according to the American Academy of Dermatolog­y . The Korsuva injection treats itching as a “kappa opioid receptor agonist” that targets the body’s peripheral nervous system, according to Cara officials.

“This drug does not have an opioid chemical core. It’s not an opioid,” Chalmers said. “But it does interact with a receptor that’s in the opioid receptor ‘family.’”

Approval of the Korsuva injection followed a priority review of the drug that the

FDA granted in March. The expedited assessment was facilitate­d by the agency awarding a “breakthrou­gh therapy” designatio­n to the treatment in 2017.

Chalmers said that he was also pleased that the Korsuva injection had not been “scheduled” nor required any license from the Drug Enforcemen­t Administra­tion. Based on their potential for abuse or dependency and accepted medical use, potent drugs can be grouped into five categories or “schedules” by the federal government.

“This is very good news for the hemodialys­is patients because the drug is going to be used in an unrestrict­ed fashion,” Chalmers said. “We have produced a drug that’s certainly highly potent on the kappa receptor, but it’s not abusable. This is gratifying for us.”

In preparatio­n for the Korsuva injection’s launch, Cara last year signed a deal with the Switzerlan­d-headquarte­red Vifor Pharma for the drug’s commercial­ization across the U.S. dialysis market. That agreement built on a 2018 internatio­nal licensing deal that Cara made 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.

Cara and Vifor said in an announceme­nt about the FDA’s approval that they are “in the process of submitting the required documentat­ion to the U.S. Centers for Medicare and Medicaid Services to ensure timely reimbursem­ent and patient access to Korsuva injection.”

Through the partnershi­p, Cara will receive a 60 percent share of the new drug’s profits in non-Fresenius Medical Care clinics in the U.S. As a result of the FDA’s approval, Vifor will purchase an additional $50 million of Cara stock and make a $15 million “milestone payment” to Cara. Vifor also committed last year to an upfront payment of $100 million and an equity investment of $50 million in Cara.

“We are very excited about the FDA approval of Korsuva injection,” Vifor CEO Abbas Hussain said in a statement. “There is a significan­t unmet medical need for a targeted therapy, and we believe that Korsuva injection can fundamenta­lly change the treatment paradigm for adult (chronic kidney disease-associated pruritus) patients undergoing dialysis.”

In Cara’s pipeline is a tablet form of Korsuva, which would treat pruritus associated with atopic dermatitis — also known as eczema. Phase-three clinical trials are scheduled to start by the end of this year.

“It’s a different scale with the patient population,” Chalmers said. “There are about 200,000 to 250,000 patients that could use Korsuva injection. Atopic dermatitis occurs in about 5 percent of the U.S. population, so that is a much larger patient population.”

In the past few years, Cara has raised several hundred million dollars to support its research and developmen­t. It held its initial public offering in 2014.

“Each approval gives the company more visibility so there is more investment for the next innovation they want to work on,” said Dawn Hocevar, CEO and president of BioCT, a nonprofit advocacy group for the biotech industry. “It increases confidence that the executive team knows how to bring a promising product to market.”

Cara company employs about 80 people. Its main offices are at 107 Elm St. in downtown Stamford.

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