Further on this, Biota just announced Positive results from this...

Further on this, Biota just announced Positive results from this BTA585 phase 1 program - no doubt, the reason why the FDA have given Biota Fast-track designation on this drug.

So with Phase 2a results expected second half of 2016, BTA 585 is suddenly right up front with Vapendavir and its Phase 2b results also due second half.

All of a sudden, Biota (with two Phase 2 candidates with results due this year - one one-tracking) is going to be watched closely by analysts.  At $US1.60 with approx $50m in cash, Biota is now looking a very attractive opportunity.

Biota Announces Positive Results From Phase 1 Program for Direct Acting RSV Antiviral BTA585

Phase 2a RSV Challenge Study Planned for Q2 2016


ATLANTA, Feb. 26, 2016 (GLOBE NEWSWIRE) -- Biota Pharmaceuticals, Inc. (NASDAQ:BOTA), a biopharmaceutical company focused on the discovery and development of direct-acting antivirals that address infections that have limited therapeutic options, announced today top-line safety and pharmacokinetic (PK) data from the Phase 1 multiple ascending dose (MAD) trial of BTA585, an oral respiratory syncytial virus (RSV) fusion inhibitor in development for the treatment and prevention of RSV infections. Results from the MAD trial indicated BTA585 was generally well tolerated at all dose levels; there were no serious adverse events, and no drug-related clinically-significant adverse changes in ECGs or clinical laboratory values were observed.
"We dosed a total of 66 subjects in the Phase 1 SAD and MAD studies and the data to date indicates that oral administration of the fusion inhibitor was well tolerated at all doses tested and that antiviral levels of BTA585 were rapidly achieved and maintained in the plasma and nasal wash fluid," stated Joseph Patti, PhD, president and chief executive officer of Biota. "With these favorable safety and PK data in hand, along with the recent Fast Track designation by the FDA, we are looking forward to starting a Phase 2a RSV challenge efficacy study next quarter and anticipate top-line results in the second half of 2016."
The blinded, placebo-controlled MAD study, which was conducted in the U.S. under an Investigational New Drug (IND) Application, evaluated the safety and PK of three cohorts of healthy volunteers (100, 400, and 600 mg BTA585) dosed orally twice a day for seven consecutive days. Each of the dose cohorts consisted of eight subjects that received BTA585 and four that received placebo. Adverse events occurring in more than two BTA585-treated subjects were headache and chromaturia. Additional results showed that BTA585 plasma C_max was rapidly achieved at approximately one hour following oral dosing, exposure was dose-proportional, there was no accumulation of BTA585 over the duration of dosing and the half-life (T_1/2) was approximately five to six hours.
About Respiratory Syncytial Virus (RSV)
RSV is a major cause of acute upper (colds) and lower (pneumonia and bronchiolitis) respiratory tract infections in infants, young children, and adults. Each year in the United States, RSV accounts for an estimated 2.1 million medical visits in children under the age of five, with many of the children afflicted requiring hospitalization. At the present time there is no effective vaccine to prevent or recommended therapy to treat RSV infections.