Kadmon Begins Phase 2 Clinical Trial Assessing IPF Treatment KD025, a ROCK2 Inhibitor

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by Kara Elam |

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New York City-based Kadmon Corp., a biopharma focused on developing therapies for significant unmet medical needs, recently announced the start of the first dosing regimen in a patient in its Phase 2 clinical trial assessing the drug KD025, the company’s rho-associated coiled-coil kinase 2 (ROCK2) inhibitor, for the treatment of idiopathic pulmonary fibrosis (IPF).

The therapeutic mechanism of action of KD025 involves controlling the signaling pathways within the immune system that are linked to diseases associated with inflammation and inflammatory mediators, such as those involved in the scarring of the lungs, which occurs in conditions like IPF.

The Phase 2 clinical trial is a randomized 24-week open-label study which aims to evaluate the safety, tolerability, and activity of KD025 in IPF patients in the U.S. who have received or been offered pirfenidone (Esbriet) and/or nintedanib (Ofev).

The clinical trial is expected to enroll 36 patients who will be randomly selected into one of two treatment groups:

  • One cohort of 24 patients treated with KD025 at 400 mg;
  • One cohort of 12 patients treated with standard of care.

“This study marks Kadmon’s entry into the field of fibrosis, a disease area where we believe ROCK2 inhibition represents a promising new therapeutic approach,” Kadmon President and CEO Dr. Harlan W. Waksal, M.D., said in a company press release. “Based on our preclinical studies demonstrating the potential anti-fibrotic effects of KD025, we believe our drug may have clinical utility in IPF, a significant unmet medical need.”

In a previous release about the clinical potential of ROCK2, John L. Ryan, Ph.D., M.D., Kadmon’s executive vice president and chief medical officer, explained, “Kadmon has demonstrated the importance of ROCK2 signaling across a variety of disease settings, including in lupus. These data support our continued clinical development of KD025 for the treatment of autoimmune and fibrotic diseases.”

“These data demonstrate the cellular mechanism by which selective ROCK2 inhibition regulates the balance between pro- and anti-inflammatory immune cell responses …” added Dr. Alexandra Zanin-Zhorov, Ph.D., Kadmon’s senior director of immunology. “ROCK2 contributes to regulation of Tfh cells in the disease state, supporting the therapeutic potential of selective ROCK2 inhibition for the treatment of autoimmunity.”