Kadmon Initiates Dosing In Study For Systemic Sclerosis Drug

Kadmon Holdings, Inc. (NYSE:KDMN) announced that the first patient has been dosed in a phase II study of KD025 to treat diffuse cutaneous systemic sclerosis (SSc).

The phase II KD025-209 study will randomize 60 adults with SSc to receive KD025 200 mg QD, KD025 200 mg BID or placebo (20 per arm) for 24 weeks, followed by an open-label extension period to allow treatment for up to 52 weeks. The primary endpoint is the Combined Response Index for Systemic Sclerosis (CRISS) score at 24 weeks.

Share price of the company has increased 11% year to date compared with the industry’s growth of 3.4%.

KD025, the company’s advanced product candidate, is an oral small molecule inhibitor of Rho-associated coiledcoil kinase 2 (ROCK2). The company is conducting an open-label registration study of KD025 for the treatment of chronic graft-versus-host disease (cGVHD), a complication arising from allogenic hematopoietic stem cell transplantation.

The company is also conducting a phase II proof-of-concept study of KD025 for the treatment of idiopathic pulmonary fibrosis (IPF). Initial findings from this study demonstrated clinical benefit and tolerability of KD025 in IPF. The company expects data from this study to support the ongoing development of its novel ROCK inhibitors for the treatment of fibrotic diseases, including IPF.

Another company, Corbus Pharmaceuticals Holdings, Inc.’s (NASDAQ:CRBP) lead product, lenabasum, is being developed to treat four life-threatening diseases — systemic sclerosis (SSc), cystic fibrosis (CF), dermatomyositis (DM) and systemic lupus erythematosus (SLE).

Zacks Rank and Other Stocks to Consider

Kadmon currently has a Zacks Rank #1 (Strong Buy).

Some other similar-ranked stocks in the biotech sector are Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) and Applied Genetics Technologies Corp. (NASDAQ:AGTC) . You can see the complete list of today’s Zacks #1 Rank stocks here.

Alnylam’s loss per share estimates have narrowed from $6.90 to $6.43 for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with average beat of 8.93%.

Applied Genetics’ loss per share estimates have narrowed from $2.39 to $2.15 for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with average beat of 83.47%.

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