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news.US-based Biota Pharmaceuticals has started dosing in a 50-subject, randomized, placebo-controlled, Phase I single ascending dose (SAD) trial to evaluate the safety and pharmacokinetics (PK) of BTA585, a potent inhibitor of viral entry into cells, in healthy volunteers.
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BTA585 is an orally bioavailable compound being developed to treat respiratory syncytial virus (RSV) infections in children, the elderly and immunocompromised patients.
The Phase I SAD trial has five dose level groups ranging from 50mg to 500mg.
Biota president and chief executive officer Joseph Patti said: "The initiation of this study represents a major milestone for Biota as we continue to build our promising RSV antiviral development program.
"Given today’s limited RSV therapeutic options, both approved and in clinical development, we believe that BTA585 has the potential to reduce the significant morbidity and mortality associated with acute RSV A & B infections in both children and adults."
In order to evaluate the effect of food on the plasma PK of BTA585, one group will initially be dosed fasted then with food.
Following a safety assessment of the initial dose level groups of the SAD trial, the company intends to start dosing in a Phase I multiple ascending dose trial in the fourth quarter of this year.
Dr Patti further noted: "In addition to BTA585, we are also advancing our RSV non-fusion inhibitor program and plan to have a lead clinical candidate selected for Investigational New Drug (IND)-enabling studies by mid-2016.
"Similar to current treatment paradigms for HCV and HIV, we believe that attacking the virus with multiple compounds that exhibit different mechanisms of action could be effective as combination therapy for patients infected with RSV."