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Kadmon ROCKs


Shares of Kadmon Holdings Inc. (KDMN) rose 19% in extended trading on Monday, following positive top line results from the Company's phase II study of KD025 in Idiopathic Pulmonary Fibrosis.

Idiopathic pulmonary fibrosis, or IPF, is a serious disease caused by progressive thickening or scarring (fibrosis) of the lungs, which makes breathing difficult and prevents the heart, muscles and vital organs from receiving the oxygen they need. Shortness of breath, a persistent dry cough, and weight loss are some of the symptoms of IPF.

It is estimated that about 100,000 people in the U.S. have IPF. Although there is no cure for this disease, there are two approved treatments to manage the symptoms and slow down its progression - Boehringer Ingelheim Pharmaceuticals' OFEV (nintedanib) and Roche's Esbriet (pirfenidone).

Kadmon's KD025 is an oral, selective ROCK2 inhibitor. Before going into the trial results, let's take a look at what ROCK means.

ROCK (Rho associated coiled-coil containing protein kinase) is an "on" switch in cells. There are two isoforms - ROCK1 and ROCK2. The inhibition of ROCK activity is said to be beneficial for the treatment of a wide range of diseases, say, Autoimmune Diseases, Fibrotic Diseases, and Neurodegenerative Diseases.

In the ongoing phase II trial, for which the top line results were reported yesterday, patients with idiopathic pulmonary fibrosis who were previously treated with OFEV and/or Esbriet are randomized 2:1 to receive KD025 400 mg once a day monotherapy or best supportive care.

According to the Company, KD025 was well tolerated and demonstrated clinical benefit, with a median decline in forced vital capacity, a measure of lung function, of 48 mL at week 24, compared to a median decline of 175 mL in patients treated with best supportive care, or BSC.

A decline in forced vital capacity is associated with an increased risk of IPF progression. Treatment with KD025 reduced the proportion of patients who experienced IPF progression.

Only 20% of patients in the KD025 arm experienced marginal decline in forced vital capacity (FVC % predicted decline of more than and equal to 5%) compared to 44% of BSC patients. A marginal decline in forced vital capacity is associated with a poor outcome in idiopathic pulmonary fibrosis. (Source: European Respiratory Journal).

The study is ongoing, with 90% of patients who received KD025 for 24 weeks continuing the KD025 treatment beyond week 24, noted the Company.

The results from this study are expected to be presented at the American Thoracic Society (ATS) International Conference in May 2018.

When we alerted our premium subscribers to Kadmon Holdings on January 8, 2018 (Report titled "Will it rock?"), it was trading around $3.70. The stock closed yesterday's (Feb.12) trading at $4.84, up 0.94%. In after-hours, the stock was up 19.01% to $5.76.

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