Neurogastrx, a biotech company based in the Boston area, has announced promising results for its experimental drug,
NG101, which could potentially mitigate one of the most troublesome side effects of
Novo Nordisk's widely-used medication,
semaglutide. The drug, marketed as Wegovy for
obesity and Ozempic for
type 2 diabetes, is known to cause nausea and vomiting, leading many patients to discontinue its use.
In a recent Phase 2 trial, approximately 90 adult participants received a single 0.5 mg subcutaneous dose of semaglutide. Over the next five days, they were given either two capsules of NG101 or a placebo each day. The findings were significant: NG101 reduced nausea incidents by 40% and vomiting by 56%. This outcome presents a substantial market opportunity, potentially worth billions of dollars, according to Neurogastrx CEO James O’Mara.
O’Mara emphasized the importance of GLP-1 receptor agonists like semaglutide, which he referred to as "miracle drugs." Despite their efficacy, many patients discontinue these treatments within a year due to gastrointestinal side effects. Neurogastrx aims to address this issue with NG101, which functions as a dopamine D2 antagonist targeting the area postrema, the brain’s “nausea center.” This region is located outside the blood-brain barrier, potentially allowing NG101 to bypass central nervous system side effects associated with other dopamine modulators.
Looking ahead, Neurogastrx plans to conduct larger and longer-duration studies with NG101 before seeking regulatory approval. The company is preparing to initiate a Phase 2 or Phase 2/3 trial in the coming year. O’Mara mentioned the possibility of a Phase 3 trial involving not only semaglutide but also Eli Lilly’s similar drug, tirzepatide, to ensure comprehensive labeling.
Financially, Neurogastrx is optimistic about securing the necessary funds for advanced-stage testing. The company has begun discussions with potential partners and funding sources. In a related development, Neurogastrx completed a Phase 2 trial of NG101 for gastroparesis, a condition where the stomach cannot empty food properly. Although the results have not been publicly disclosed, O’Mara described them as “interesting” and noted that some endpoints looked promising while others did not meet expectations.
In the same field, CinDome Pharma, another biotech firm, secured a $40 million funding extension to complete its Phase 2 trial for diabetic gastroparesis. CinDome anticipates announcing results next year and may seek a pharmaceutical partner or acquirer for Phase 3 development, according to CinRx CEO Jon Isaacsohn.
O’Mara also shed light on Neurogastrx's terminated partnership with Daewoong Pharmaceutical from South Korea. Originally, Neurogastrx had agreed to develop Daewoong’s acid blocker fexuprazan for gastroesophageal reflux disease (GERD) and related conditions in the US and Canada. However, due to difficulties in raising capital, the agreement was terminated in mid-2023. O’Mara explained that the decision was made to provide Daewoong the opportunity to collaborate with a company better suited to advance the drug.
In summary, Neurogastrx is making significant strides with NG101, potentially offering a solution to the gastrointestinal side effects that hinder the long-term use of semaglutide. As the company moves forward with further trials and explores funding opportunities, it remains committed to addressing unmet medical needs in gastrointestinal health.
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