Taipei-based inhaled drug developer Asia Scientific Global announced that it has completed a pre-IND meeting with the US FDA regarding its Beta 1 dry powder inhaler, a PDE-5 inhibitor that the company is developing for the treatment of erectile dysfunction. The company said that, “ASG will expedite the revision of clinical trial documents and execute additional test [sic] based on FDA’s guidance” with plans for an IND submission and initiation of a Phase I trial by the end of this year.
According to ASG, the Beta-1 formulation, which is based on its aPPC (aero-particles process control) technology, “has to date shown better-than-expected results in various preclinical evaluations, drug toxicology and pharmacokinetic tests,” with absorption occurring within 10 minutes.
In addition to Beta 1, which is the company’s lead candidate, ASG is developing DPIs for the treatment of tuberculosis (Alpha 1) and for the reduction of respiratory mucosal secretions (Gamma 1). All of the formulations are designed for delivery by a proprietary device, which ASG’s web site says includes electronic sensors that interface with proprietary AI technology.
Read the Asia Scientific Global press release
