Kadmon Holdings Inc (NASDAQ:KDMN) commenced an open-label phase 2 clinical study of Belumosudil by administering the first patient, who suffers from dcSSC (diffuse cutaneous systemic sclerosis).
Enrolls 15 patients
Kadmon will recruit 15 patients with diffuse cutaneous systemic sclerosis in Phase 2 clinical study (KD025-215). They will receive 200 mg of belumosudil daily two times orally. Its main target is to obtain CRISS (Combined Response Index for Systemic Sclerosis) score. Kadmon will publish the initial trial data by the end of 2021.
Kadmon also enrolls 60 patients with dcSSC in the placebo-controlled, double-blind Phase clinical study of belumosudil (KD025-209). The company will administer the patients randomly with 200 mg of belumosudil once every day.
CEO and President of Kadmon, Harlan W. Waksal, said the company begins the clinical study of belumosudil in patients with dcSSC while awaiting a placebo-controlled trial. The company is excited with robust responses accomplished in all the organs in the clinical study involving belumosudil in cGVHD. The company’s belumosudil received an ODD (orphan drug designation) from the US FDA to cure systemic sclerosis.
Kadmon announces results of phase 2a clinical study of KD025
Kadmon published results of phase 2a clinical study of KD025 (belumosudil) to treat cGVHD (chronic graft-versus-host disease) in the Journal of Clinical Oncology on April 21, 2021.
The US FDA reviews the NDA (New Drug Application) for belumosudil for curing patients with cGVHD.
Harlan said the company demonstrated meaningful results in the first clinical study of belumosudil in treating patients suffering from cGVHD. It also replicated the positive results in the ROCKStar pivotal study of belumosudil. On receipt of the FDA nod, the company can satisfy the urgent need for new therapies.
Kadmon enrolled 54 patients, who are already administered one to three prior lines of therapy, in the Phase 2a clinical trial of KD025-208. The results from this clinical trial showed 65% ORR (pooled Overall Response Rate) in all three patient cohorts. 50% of the respondents in the trial demonstrated improvement in symptoms. It also reduced the need for administering steroid doses in 67% of the patients. Steroid use is completely discontinued in 19% of the patients. The drug showed improved tolerability in all patient cohorts.
