BioVie Reports Data From NE3107 Phase 3 Trial; To Work With FDA To Employ Adaptive Trial Feature

(RTTNews) - BioVie Inc. (BIVI) reported positive analysis of unblinded, topline efficacy data from Phase 3 clinical trial of NE3107 in the treatment of mild to moderate Alzheimer's Disease. The company said the data showed NE3107's treatment advantage compared to placebo may be equal to or greater than the benefit from approved AD monoclonal antibodies. NE3107-treated patients experienced a 4.66-year advantage in age deceleration vs. placebo.

"The unblinded topline efficacy data from 57 per-protocol participants reaffirmed what has been seen in previous studies of NE3107 - which is that patients treated with this molecule appear to experience cognitive and functional improvements as measured by multiple assessment tools," said Joseph Palumbo, Chief Medical Officer.

BioVie noted that the trial was originally designed to be 80% powered with 125 patients in each of the treatment and placebo arms. The exclusion of so many patients has left the trial unpowered for the primary endpoints. Based on the efficacy signal, the company plans to work with the FDA to potentially employ the adaptive trial feature of the protocol to continue enrolling patients to achieve statistical significance.

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