| |
NGM Bio Reports Topline Results from 24-Week Phase 2b ALPINE 2/3 Study of Aldafermin in NASH - Will Not Pursue Phase 3
|
| |
| |
May 24, 2021 at 7:00 AM EDT
https://ir.ngmbio.com/news-releases/news-release-details/ngm-bio-reports-topline-results-24-week-phase-2b-alpine-23-study
• Study did not meet primary endpoint of fibrosis improvement by >1 stage with no worsening of NASH versus placebo
• Statistical significance achieved versus placebo on certain secondary endpoints, including NASH resolution (at the 3 mg dose) and multiple non-invasive measures of NASH, including liver fat content reduction by MRI-PDFF, ALT, AST and Pro-C3 (at the 1 mg and 3 mg doses)
• Aldafermin was generally well tolerated with an overall safety profile similar to placebo
• NGM plans not to pursue Phase 3 clinical development of aldafermin in F2/F3 NASH; will focus on its growing ophthalmology and oncology portfolio
• Company to host conference call and webcast today at 8:30 a.m. ET (5:30 a.m. PT)
SOUTH SAN FRANCISCO, Calif., May 24, 2021 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc.
(NGM) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today reported results from the 24-week Phase 2b ALPINE 2/3 study evaluating aldafermin in 171 patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH) with stage 2 or 3 liver fibrosis (F2/F3). The trial was an equally randomized, double-blind, placebo-controlled study that assessed the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of aldafermin once-daily subcutaneous injections compared to placebo. The study did not meet its primary endpoint evaluating a dose response showing improvement in liver fibrosis by >1 stage with no worsening of NASH at week 24 (p=0.55), analyzed using a dose response-driven statistical analysis plan (Multiple Comparison Procedure Modeling, or MCP-Mod). The study did achieve statistical significance versus placebo on certain secondary endpoints, including NASH resolution (at the 3 mg dose) and multiple non-invasive measures of NASH, including liver fat content reduction by MRI-PDFF, ALT, AST and Pro-C3 (at the 1 mg and 3 mg doses).
"These results are certainly disappointing, particularly given the dire unmet need in this patient population. The lack of significant fibrosis improvement was unexpected given the consistency of histology findings previously seen with aldafermin in our adaptive four-cohort Phase 2 study," said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM. "However, in line with the data from that study, ALPINE 2/3 achieved statistical significance on multiple non-invasive measures of NASH at the two higher doses. That said, given the failure to meet the primary endpoint, we have decided to shift resources that had previously been reserved for a Phase 3 F2/F3 NASH development program toward advancing our other programs."
Dr. Woodhouse further commented, "NGM is a markedly different company than when we initiated ALPINE 2/3 in May 2019, when our clinical-stage pipeline consisted primarily of liver and metabolic programs. Over the past two years, we have steadily expanded that pipeline with programs generated from our productive in-house discovery engine, and today we are also an ophthalmology and oncology company with four Phase 2 programs underway. We look forward to advancing our clinical programs and moving additional programs into the clinic, supported by our cash balance that was in excess of $400 million at the end of the first quarter."
NGM's disclosed pipeline includes: NGM621, an anti-complement C3 antibody, currently in Phase 2 development for the treatment of geographic atrophy; NGM120, a GFRAL antagonistic antibody in Phase 2 development for the treatment of metastatic pancreatic cancer and cancer-related cachexia; and NGM707 and NGM438, anti-ILT2/ILT4 and LAIR1 myeloid checkpoint candidates, respectively, both of which are anticipated to begin Phase 1 studies for the treatment of advanced solid tumors this year. Additionally, Merck continues to progress a global Phase 2b study of MK-3655, an FGFR1c/KLB agonistic antibody for the treatment of NASH, which was discovered by NGM under its collaboration with Merck.
| |
| |
| |
|
|
|
