BERWYN, PA — Virpax Pharmaceuticals, Inc. (Nasdaq: VRPX) has commended Nanomerics for the successful completion of a human study utilizing its proprietary Molecular Envelope Technology (MET). The Phase I SUNLIGHT trial demonstrated no moderate to severe adverse events during the 28-day study, marking a significant milestone for the application of MET in advanced drug delivery methods.
Virpax integrates Nanomerics’ MET in its flagship products, Envelta and NobrXiol, aimed at delivering innovative treatments for pain and epilepsy. Envelta, an enkephalin-based drug leveraging nanotechnology, is designed to cross the blood-brain barrier to suppress pain by binding to delta opioid receptors. “Envelta has demonstrated analgesic potential in animal models without the development of opioid tolerance or reward-seeking behavior,” according to the company. Envelta is being developed in collaboration with the National Center for Advancing Translational Sciences (NCATS), a branch of the NIH.
Similarly, NobrXiol utilizes MET to enhance the delivery of cannabidiol for epilepsy management in children and adults. By using MET, cannabidiol particles bypass traditional barriers, reaching the brain via the olfactory nerve. NobrXiol has already received pre-Investigational New Drug (PIND) application guidance from the FDA.
Promising Results from the SUNLIGHT Trial
Nanomerics conducted the SUNLIGHT trial to evaluate the safety of MET when integrated into eye drops. This Phase I trial involved 28 days of dosing in healthy volunteers, with no dropouts recorded among the participants. During the trial, volunteers were administered two doses daily of either MET eye drops or OC134 eye drops (powered by MET).
The comprehensive safety assessments revealed no moderate or severe adverse events. Tests covering bloodwork, vital signs, eye examinations, ECGs, and urinalysis showed no significant deviations from baseline. The trial demonstrated that topical MET applications were well-tolerated across 56 consecutive doses.
Implications for Drug Delivery
The success of the SUNLIGHT trial underscores the potential of MET to revolutionize drug delivery, including the ability to effectively bypass biological barriers. Brendan Lake, CEO of Virpax, highlighted MET’s broad applications, emphasizing its role in delivering cutting-edge therapeutics with high precision and safety.
The trial results are an encouraging step forward in the development of MET-powered solutions, reinforcing confidence in the technology’s ability to advance pain management and epilepsy treatment. Follow-up assessments for the SUNLIGHT trial participants are slated for completion in February 2025, paving the way for further clinical exploration.
As Virpax and Nanomerics continue their work, the advancements in MET provide hope for addressing some of the most challenging barriers in drug delivery. These developments signal an exciting future for innovative therapeutic solutions powered by this groundbreaking technology.
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