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BOTA: Clinical Trial Update

By Anita Dushyanth, PhD


Following the successful Single Ascending Dose (SAD) study, Biota (BOTA) completed the Phase 1 multiple ascending dose (MAD) study in the beginning of 2016. The MAD study was double-blinded, placebo-controlled and designed to evaluate the safety and pharmacokinetic profile (PK) of three groups (100, 400, and 600 mg BTA585) of healthy volunteers.  The subjects were dosed orally twice a day for seven consecutive days.  In each group, eight subjects received BTA585 and four received  placebo.

As anticipated, the company released the safety and PK results at the end of February 2016 (http://finance.yahoo.com/news/biota-announces-positive-results-phase-113000726.html).  The results indicated that BTA585 was generally well tolerated at all dose levels.  There was no occurrence of clinically significant adverse events, changes in ECGs or abnormal clinical lab values. The only adverse events that occurred in more than two BTA585-treated subjects were headache and chromaturia.  The peak plasma concentration was rapidly achieved in about one hour following oral dosing.  The half-life of BTA585 was roughly five to six hours.

In February 2016, the company received positive news from the FDA.  By recognizing BTA585’s potential to address the unmet medical need to treat RSV infections, the FDA granted Fast Track designation for BTA585.  With positive trial results and the recent Fast Track designation by the FDA, management is looking forward to initiate the Phase 2a RSV challenge efficacy study shortly.  The topline data from this Phase 2 trial is expected during 2H 2016.


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