Kadmon falls after Phase II IPF data

Kadmon Holdings Inc. (NYSE:KDMN) fell $1.03 (21%) to $3.81 on Tuesday after reporting top-line data from the Phase II KD025-207 trial of KD025 to treat idiopathic pulmonary fibrosis in patients previously treated with or offered Esbriet pirfenidone or Ofev nintedanib.

The company did not disclose p-values from the open-label trial, which may have left investors uncertain as to how the compound will stack up against marketed IPF drugs. Investors may need to wait until May for details, when Kadmon plans to present the data at the American Thoracic Society meeting in San Diego.

In 29 patients who were evaluable on the trial's primary efficacy endpoint, the median decline in forced vital capacity (FVC) from baseline to week 24 was 48 mL in the once-daily 400 mg oral KD025 arm compared to a median decline of 175 mL for best supportive care (BSC). Additionally, the median decline in FVC percent predicted from baseline to week 24 was 1% in patients who received KD025 vs. a median decline of 2% in BSC patients. KD025 also reduced the proportion of patients with IPF progression, defined as a decline in FVC percent predicted of at least 5%, vs. BSC (20% vs. 44%).

On the trial's primary safety endpoint, Kadmon said KD025 was well tolerated with no treatment-related serious adverse events reported. Seven patients withdrew from the KD025 arm due to adverse events, including one treatment-related adverse event of grade 3 liver function test elevations. Other adverse events that led to withdrawal were basal ganglia hemorrhage, carcinoma, congestive heart failure (CHF), dyspnea, hypotension and death due to an unknown cause.

By mid-year, Kadmon plans to start a blinded, placebo-controlled Phase II trial of KD025 in 150 patients with IPF.

KD025 is an oral selective inhibitor of Rho-associated coiled-coil containing protein kinase 2 (ROCK2). The product is also in Phase II testing to treat chronic graft-versus-host disease (GvHD).