“We will now rapidly advance our New Drug Application submission to the FDA and we look forward to presenting a comprehensive analysis of these positive results at a medical conference next year,” Aicuris CEO Larry Edwards said in an Oct. 16 release.

The trial is important because refractory HSV infections “pose a significant challenge for patients whose immune systems are impaired,” according to Cynthia Wat, M.D., the chief medical officer of Aicuris.

Immunocompromised patients are susceptible to more severe, lengthy and refractory HSV infections that do not respond to SOC treatments, Aicuris pointed out. The outbreaks can cause painful lesions and can increase the likelihood of hospitalization and the spread of the infection.

“With encouraging safety, convenient oral dosing and the statistically superior efficacy in treating R+R HSV as demonstrated in this pivotal trial, pritelivir could be a paradigm shift for immunocompromised patients globally,” Wat added.

An approval of pritelivir—which targets both HSV-1, which is primarily spread through oral contact, and HSV-2, which is primarily spread by genital contact—would bring a new mechanism of action to HSV treatment. Unlike traditional antivirals, pritelivir blocks viral DNA synthesis by inhibiting the helicase-primase complex, the company explained.

Since pritelivir does not rely on activation by viral enzymes, it can “overcome HSV infections that are R+R to SOC treatments,” added Aicuris, a 2006 spinout of Bayer based in Wuppertal, Germany.