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Gastroparesis drug candidate development moves forward with new financing
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Biopharmaceutical company Neurogastrx announced it has raised $45 million in Series A financing, which will allow them to bring their lead drug candidate for gastroparesis through proof-of-concept development.
“This is an incredible opportunity for us to drive our lead asset to proof of concept without the distraction of having to raise additional funds,” newly appointed CEO Jim O’Mara said in a press release. “Our sole focus is on creating a robust data package to validate the utility of NG-101.”
NG-101 is a selective and peripherally restricted dopamine D2/D3 receptor antagonist, which does not carry the neurological and cardiovascular side effects of other D2 antagonists, according to the company’s website.
Preclinical studies have shown the drug candidate has potent antiemetic properties and may “significantly increase gastric motility, conferring NG-101 an ideal pharmacological profile for the treatment of gastroparesis,” according to the website. It also noted that pro-kinetic approaches alone are not effective for treating gastroparesis, which suggests that nausea and vomiting are important symptoms not addressed by current therapies.
Gastroparesis, which lacks effective treatment options, is characterized by delayed gastric emptying with no mechanical obstruction of the stomach, and the most common symptoms include nausea, vomiting, early satiety, abdominal pain and bloating.
“The constellation of symptoms from which these patients suffer all originate from the gut-brain axis, the pathway by which the enteric nervous system communicates with the brain,” Cyril De Colle, founder and chief scientific officer of Neurogastrx, said in the press release. “NG-101 modulates receptors within this pathway, which we believe will improve these symptoms.”
Healio Gastroenterology and Liver Disease recently spoke with another company founder, Pankaj Jay Pasricha, MD, MBBS, of Johns Hopkins University School of Medicine, who explained that the promise of NG-101 lies in its potentially improved tolerability vs. other D2 receptor antagonists.
“The only drug that’s been approved by the FDA for gastroparesis is metoclopramide [Reglan], a first generation D2 receptor antagonist, and it has quite significant neurological side effects because it crosses the blood-brain barrier,” he said.
A second generation D2 antagonist, domperidone (Janssen), is “widely used across the world,” but has never been approved by the FDA, Pasricha said. Fortunately, domperidone “does not cross the blood-brain barrier, so it does not cause the neurological side effects of metoclopramide, but it is increasingly being restricted in its use because of its cardiovascular side effects,” he added.
The promise of NG-101, according to Pasricha, is that it is as potent as domperidone in terms of its D2 receptor antagonistic activity, and more potent than metoclopramide, “but has neither of these drugs’ side effects; it doesn’t cross the blood-brain barrier, and does not have cardiovascular toxicity.” Thus, “it is in a class of drugs proven to be effective in gastroparesis, but doesn’t have the side effects of the others,” he said.
He added that the drug has been widely used in Europe for acute nausea for almost 40 years, and randomized clinical trials have shown it to be effective in managing nausea.
“That’s why we think that this will be a very effective therapy for patients with gastroparesis,” which is sorely needed given the large unmet need in treating this condition, he said.
“Chronic nausea in general does not have very effective therapies and in gastroparesis that’s the cardinal symptom. The traditional method of treating gastroparesis is simply to accelerate gastric emptying, and we know by just doing that we may not ameliorate all the symptoms, so we think we need more than just prokinetic activity. This realization has come about in the last few years, and researchers are working towards more effective approaches.”
Pasricha said he expects clinical trials of NG-101 to begin later this year.
The company will also use the newly raised funds to fill out their management team and relocate their headquarters to the greater Boston area, according to the press release. – by Adam Leitenberger
Disclosures: Pasricha, Colle and O’Mara are employed by Neurogastrx.