FDA accepts IND with partial clinical hold for oral small molecule Alzheimer’s treatment

The FDA has accepted an investigational new drug application for VG-3927, an oral small molecule TREM2 agonist for the potential treatment of Alzheimer’s disease, according to the manufacturer.

Vigil Neuroscience announced in a press release that the acceptance allows the biotech firm’s phase 1 clinical trial in healthy volunteers to proceed with a partial clinical hold related to maximum exposure limit.

Based on results of preclinical studies, Virgil said it believes that the maximum exposure limit exceeds the predicted efficacious dose of VG-3927. The company also says that from the initial comments received from the FDA, it believes the partial clinical hold was not a result of any preclinical toxicology findings or TREM2 pharmacology. The company anticipates further details from the FDA within the next 30 days and expects to work closely with it to address the issue.

"VG-3927 is the first and only small molecule TREM2 agonist in the clinic for Alzheimer’s disease (AD). Orally bioavailable and highly CNS penetrant, VG-3927 functions through a differentiated molecular mechanism with potential to address unmet needs in AD related to safety, efficacy, and dosing," Vigil Neuroscience CEO & President, Ivana Magovčević-Liebisch, PhD, JD, told Healio in an email.

Vigil additionally stated it does not anticipate any delays in development plans for VG-3927 and expects to begin dosing healthy volunteers shortly.