June 5, 2019 at 7:00 AM EDT

NGM Bio to Present New Data from Phase 1b Study of NGM313 at 79th Scientific Sessions of the American Diabetes Association

SOUTH SAN FRANCISCO, Calif., June 05, 2019 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (Nasdaq: NGM), a clinical stage biotechnology company focused on developing transformative therapeutics for patients, today announced that it will present new data from a Phase 1b study of NGM313 at the 79th Scientific Sessions of the American Diabetes Association (ADA) taking place in San Francisco June 7 - 11, 2019. 

As part of their ongoing strategic collaboration, NGM and Merck, known as MSD outside the United States and Canada, announced in January 2019 that Merck exercised its option to license NGM313, now renamed MK-3655. Merck intends to advance MK-3655 into a Phase 2b study to evaluate the effect of MK-3655 on liver histology and glucose control in NASH patients with or without diabetes. NGM313 (MK-3655) is an investigational agonistic antibody that selectively activates the β-Klotho/FGFR1c receptor complex. The Phase 1b randomized, open-label, active-controlled parallel group study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of NGM313 in obese, insulin resistant subjects with non-alcoholic fatty liver disease (NAFLD). NGM presented data from the Phase 1b study at the European Association for the Study of the Liver’s (EASL) The International Liver Congress™ (ILC) in April 2019 and the AASLD’s The Liver Meeting® in November 2018.

The new data to be presented at a late breaker poster presentation at the ADA meeting include the evaluation of whole-body insulin sensitivity of a single dose of NGM313 compared to daily dosing of pioglitazone (45 mg), as determined by a two-step hyperinsulinemic, euglycemic clamp.

As previously presented, the Phase 1b data demonstrated that a single dose of NGM313 resulted in a statistically significant reduction in liver fat content, and improvements in multiple metabolic parameters, including improved insulin sensitivity, reduced HbA1c and fasting glucose levels, lowered triglycerides and LDL-C, and raised levels of HDL-C. NGM313 was well-tolerated, with no serious adverse events. All adverse events observed during the course of the study were deemed mild, with increased appetite and injection site reactions being the only adverse events reported in at least 10% of the NGM313-treated subjects (n=17). 

Late Breaker Poster Presentation Details:

Title:  NGM313, a novel activator of β-klotho/FGFR1c, improves insulin resistance and reduces hepatic fat in obese, non-diabetic subjects
Poster number: 140-LB
Presenter:  Alex DePaoli, M.D., Senior Vice President, Chief Translational Officer, NGM Bio
Session:  12-F Clinical Therapeutics/New Technology–Other Therapeutic Agents
Date:  Sunday, June 9, 2019 from 12:00 – 1:00 p.m.
Location:  Poster Hall

A copy of the poster will be posted on the investor relations portion of NGM’s website at ir.ngmbio.com/events-presentations.

About NGM313 (MK-3655)

NGM313 (MK-3655) is a proprietary investigational agonistic antibody that selectively activates the β-Klotho/FGFR1c receptor complex. NGM313 (MK-3655) binds to a unique epitope of β-Klotho, resulting in the selective activation of FGFR1c signaling through one of the metabolic pathways utilized by FGF21-based ligand therapies. It does not trigger signaling through other FGF receptors, such as FGFR2c, FGFR3c or FGFR4. In Phase 1 studies, NGM313 demonstrated potential as a once-monthly injectable insulin sensitizer.    

About NGM Biopharmaceuticals, Inc.
NGM is a clinical stage biopharmaceutical company focused on developing novel therapeutics based on scientific understanding of key biological pathways underlying cardio-metabolic, liver, oncologic and ophthalmic diseases. The company leverages its biology-centric drug discovery approach to uncover novel mechanisms of action and generate proprietary insights that enable it to move rapidly into proof-of-concept studies and deliver potential first-in-class medicines to patients. NGM aspires to operate one of the most productive research and development engines in the biopharmaceutical industry, with multiple programs in clinical development. Visit http://www.ngmbio.com for more information.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to NGM’s advancement of its clinical and preclinical pipeline and NGM’s expectation that Merck intends to advance the MK-3655 program into a Phase 2b study to evaluate the effect of MK-3655 on liver histology and glucose control in NASH patients with or without diabetes. Because such statements deal with future events and are based on NGM’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of NGM could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including those discussed in the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our quarterly report on Form 10-Q for the quarter ended March 31, 2019 and other filings that we make from time to time with the SEC. Except as required by law, NGM assumes no obligation to update these forward-looking statements, or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.

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