BioAlliance Pharma Reports Positive Preliminary LIP Phase III Results

BioAlliance Pharma has reported positive preliminary results for its LIP phase III pivotal, multicenter randomised, double-blind, placebo controlled study (Lauriad Immunocompetent Patients Study).

The company said that this study compared the efficacy and safety of a single dose acyclovir Lauriad 50mg Mucoadhesive Buccal Tablet (MBT), versus matching placebo in patients suffering from recurrent oro-facial herpes.

In the acyclovir Lauriad patient group among the 722 patients included, the duration of episode from the first prodromal symptoms to healing was significantly decreased (p=0.0062).

In addition, the percentage of patients with abortive lesions was reportedly increased (p=0.051) and among patients presenting primary vesicular lesions, the time to healing was reduced (p=0.058).

Dominique Costantini, president and CEO of BioAlliance Pharma, said: “These data show that acyclovir Lauriad brings a strong clinical benefit to patients both in preventing and treating recurrent oro-facial herpes. This trial provides a good basis for a constructive dialogue with the regulatory authorities. These results strongly validate the Mucoadhesive Buccal Tablet concept based on early targeted treatment.”