Neurogastrx Reports Positive Data for NG101 in Reducing GLP-1 Agonist-Induced Nausea and Vomiting

Neurogastrx, Inc. has announced promising top-line results from a new study involving NG101 (metopimazine mesylate), which shows a significant reduction in the side effects of nausea and vomiting caused by glucagon-like peptide 1 (GLP-1) agonist medication. NG101 is an oral dopamine D2 receptor antagonist that operates peripherally.

Dr. Cyril De Colle, Chief Scientific Officer of Neurogastrx, stated that the randomized, double-blind, placebo-controlled proof-of-concept (POC) study demonstrated the positive effects of NG101. Participants in the study were administered double the starting dose of the GLP-1 agonist semaglutide. According to Dr. De Colle, the study's findings indicate that NG101 could be a valuable addition to GLP-1 agonist therapy, aiding patients in adhering to treatment as they transition to higher doses necessary for weight loss and overall health improvement.

The key efficacy endpoints of the study revealed significant results for NG101:
- A reduction in the incidence of nausea by 40% (p=0.0343)
- A reduction in the frequency of vomiting by 56% (p=0.0412)
- A decrease in the duration of nausea (p=0.0101)
- A reduction in the participant-reported severity of nausea (p=0.0225)

Importantly, adding NG101 to semaglutide dosing did not result in any new safety concerns, including the incidence of other common adverse events such as diarrhea or constipation. The study reported no serious adverse events and no discontinuations due to treatment-emergent adverse events (TEAEs).

Gastrointestinal (GI) adverse events, particularly nausea and vomiting, are significant challenges to the titration and adherence of GLP-1 therapy. A recent study using 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. James O’Mara, President and CEO of Neurogastrx, mentioned that the POC study offers hope to patients who struggle to tolerate these medications long enough to benefit from them. Neurogastrx plans to discuss with the FDA the initiation of a larger Phase 2/3 study in 2025 to bring this product to patients.

The study design included 90 participants aged 18-55 who received a single subcutaneous dose of semaglutide (0.5 mg) along with five days of NG101 20 mg twice daily (BID) or placebo. The study evaluated NG101's efficacy in reducing the incidence, duration, and severity of nausea and vomiting. The efficacy endpoints measured were:
- The 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.

Additionally, the study assessed NG101's safety (20 mg BID) in participants receiving a single subcutaneous injection of the GLP-1 agonist. The primary safety endpoints included the incidence and severity of TEAEs (other than nausea and vomiting), as well as standard laboratory assessments.

Neurogastrx, Inc. is a privately held specialty pharmaceutical company dedicated to developing transformative therapies for gastrointestinal disorders, addressing unmet patient needs and disease burdens.