WOBURN, Mass., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Neurogastrx, Inc. today announced positive topline results from a new study of NG101 (metopimazine mesylate) showing significant reduction of nausea and vomiting side effects caused by a glucagon-like peptide 1 (GLP-1) agonist medication. NG101 is an oral, peripherally restricted dopamine D2 receptor antagonist.
“The randomized, double-blind, placebo-controlled proof-of-concept (POC) safety and efficacy study showed positive effects of NG101 in participants who received double the starting dose of the GLP-1 agonist semaglutide,” said Cyril De Colle, Ph.D., Chief Scientific Officer, Neurogastrx. “Findings from this study suggest NG101 could be an important addition to GLP-1 agonist therapy, helping more patients adhere to treatment as they transition to the higher doses needed to reach weight loss and broader health goals.”
Key efficacy endpoints showed NG101 significantly:
- Reduced the incidence of nausea by 40% (p=0.0343)
- Reduced the frequency of vomiting by 56% (p=0.0412)
NG101 also significantly reduced both the duration of nausea (p=0.0101) and the participant-reported severity of nausea (p=0.0225).
The addition of NG101 to semaglutide dosing was not associated with any new safety findings, including the incidence of other common adverse events (AEs) such as diarrhea or constipation. There were no serious AEs and no discontinuations due to treatment emergent adverse events (TEAEs) in the study.
Gastrointestinal (GI) adverse events, especially nausea and vomiting, are the primary challenge to titration and adherence of GLP-1 therapy. A recent real-world adherence study utilizing an IQVIA database followed over 160,000 new semaglutide weight loss patients and showed a 50% discontinuation rate at six months and 70% at one year. “Our POC study offers hope to patients who cannot tolerate these medicines long enough to realize their benefits,” said James O’Mara, President and Chief Executive Officer, Neurogastrx. “We look forward to discussions with the FDA to initiate a larger Phase 2/3 study in 2025, with the goal to bring this product to patients.”
Study Design
A total of 90 participants aged 18-55 received a single subcutaneous dose of semaglutide (0.5 mg) along with five days of NG101 20 mg twice per day (BID) or placebo. The study evaluated the efficacy of NG101 in reducing the incidence, duration and severity of nausea and vomiting. Efficacy endpoints included:
- Number of days with TEAEs of nausea and/or vomiting within four days (96 hours) following a single subcutaneous GLP-1 agonist injection.
- Moderate and/or severe TEAEs of nausea and/or vomiting within four days (96 hours) following a single subcutaneous GLP-1 agonist injection (as graded by the principal investigator or designee).
- TEAEs of nausea and/or vomiting within four days (96 hours) following a single subcutaneous GLP-1 agonist injection.
The study also evaluated the safety of NG101 (20 mg BID) in participants receiving a single subcutaneous injection of the GLP-1 agonist.
Primary safety endpoints included incidence and severity of TEAEs (other than nausea and vomiting), and standard laboratory assessments. For more details, go to www.clinicaltrials.gov, NCT006500429.
About Neurogastrx, Inc.
Neurogastrx, Inc. is a privately held specialty pharmaceutical company developing transformative therapies to advance the treatment of GI disorders for which meaningful therapeutic innovation is required to satisfy unmet patient need and disease burden.
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