On a day when world financial markets traded lower across the board, shares of biotechnology company NGM Biopharmaceuticals Inc. (NGM:NASDAQ) traded more than 35% higher at times reaching a new 52-week high stock price. Earlier today, the firm which is engaged in developing transformative therapeutics for patients, announced positive preliminary topline results from Cohort 4 of its Phase 2 study of aldafermin in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH) with stage 2 or 3 liver fibrosis (F2-F3).
Aldafermin is NGM's leading wholly owned drug candidate which the company describes as "an engineered variant of the human hormone FGF19 being developed as a once-daily subcutaneous injection for treatment for patients with NASH."
The firm indicated that Cohort 4 of the Phase 2 study was modeled to demonstrate the effect of aldafermin treatment versus placebo on the primary endpoint of change in absolute liver fat content. The firm noted that aldafermin achieved statistical significance in the primary endpoint as well as in several secondary endpoints of liver histology and biomarkers of disease activity.
Stephen A. Harrison, M.D., medical director at Pinnacle Clinical Research, visiting professor of hepatology at University of Oxford, and principal investigator on the study, commented, "To my knowledge, aldafermin is the first drug to demonstrate a robust, statistically significant effect of greater than 20% of patients achieving the FDA composite regulatory endpoint of fibrosis improvement and resolution of NASH versus placebo, as well as show an impressive impact on both of these endpoints independently...These preliminary results are remarkable and show that aldafermin's rapid and profound effect across all histological measures of NASH previously seen at 12 weeks is sustained, and also suggest that extended treatment may lead to further improvement in liver health. Moreover, these data further strengthen aldafermin's potential as a transformative monotherapy for NASH patients with established fibrosis."
The company's SVP and Chief Medical Officer Hsiao D. Lieu, M.D., added, "We're very pleased with these data, as they are consistent with the comprehensive body of efficacy and tolerability data generated in over 200 aldafermin-treated NASH patients across our multi-cohort Phase 2 aldafermin program. Given that aldafermin has a promising effect on fibrosis and NASH resolution and is well tolerated, we believe this drug could be a central tool in the future treatment landscape of NASH. We look forward to furthering our Phase 2b clinical development program and advancing aldafermin into pivotal studies."
NGM Biopharmaceuticals' CEO David J. Woodhouse, Ph.D., remarked, "We are committed to delivering powerful new therapies to address some of today's most widespread and difficult medical challenges. The successful completion of this Phase 2 study brings us a critical step closer to achieving that goal for NASH patients."
NGM Biopharmaceuticals is based in South San Francisco, Calif., and states that "it is focused on developing novel therapeutics based on a scientific understanding of key biological pathways underlying cardio-metabolic, liver, oncologic and ophthalmic diseases."
NGM Biopharmaceuticals began the day with a market capitalization of around $1.1 billion with approximately 66.66 million shares outstanding and a short interest of about 2.5%. NGM shares opened nearly 36% higher today at $22.00 (+$5.81, +35.89%) over Friday's $16.19 closing price and reached a new 52-week high price this morning of $22.95. The stock has traded today between $18.38 to $22.95 per share and is presently trading at $19.46 (+$3.27, +20.20%).
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