First SSc Patient Dosed with Investigational Inhibitor KD025 in Phase 2 Trial

First SSc Patient Dosed with Investigational Inhibitor KD025 in Phase 2 Trial
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KD025 Phase 2 trial

Kadmon Holdings started a Phase 2 clinical trial testing its inhibitor KD025, with the first patient with diffuse cutaneous systemic sclerosis (SSc) being dosed, the company announced.

KD025 is a selective, orally available inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2), an enzyme involved in signals that modulate the inflammatory response.

The Phase 2 study (called KD025-209, NCT03919799) is expected to enroll approximately 60 adults with diffuse cutaneous SSc who will be randomized to receive 200 mg of KD025 once or twice a day, or a matched placebo for 28 weeks.

Following completion of this treatment period, participants will start to receive open-label KD025 therapy for up to a total of 52 weeks. Those who initially received a placebo will be re-randomized to start treatment with one of the two doses of the inhibitor.

The study was designed to assess the safety and efficacy of KD025 by determining changes in skin scarring and disease severity compared to placebo treatment.

Researchers will assess changes in the Modified Rodnan Skin Score (mRSS) and forced vital capacity (FVC), which measure skin thickness and respiratory capacity, respectively. Participants’ quality of life will be evaluated based on the Health Assessment Questionnaire-Disability Index (HAQ-DI).

For more information about this trial, and how to participate, please visit its webpage.

“We are pleased to extend our development of KD025 to systemic sclerosis,” Harlan W. Waksal, MD, president and CEO at Kadmon, said in a press release. “This new study of KD025 further supports our goal to develop therapies for patients with serious unmet medical needs, particularly in inflammatory and fibrotic diseases.”

KD025 was first explored as a potential therapy for chronic graft-versus-host disease (cGVHD), a potentially life-threatening complication following cell transplant. This disease shares features of both autoimmune and fibrotic diseases similar to SSc, including aberrant immune system activation and consequent multi-organ fibrosis.

The investigational inhibitor has received breakthrough therapy and orphan drug designations from the U.S. Food and Drug Administration (FDA) for the treatment of cGVHD.

Results from an ongoing Phase 2 trial (KD025-208, NCT02841995) in adults with cGVHD showed that KD025 is well-tolerated and can significantly alleviate symptoms.

“Based on encouraging results observed with KD025 in cGVHD patients, including responses in hard-to-treat fibrotic manifestations in lung and skin, we believe KD025 is well-suited to treat patients with systemic sclerosis,” Waksal said.

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