TAIPEI, Feb. 26, 2025 /PRNewswire/ -- Asia Scientific Global (ASG), a company specializing in the research and development of novel inhaled novel drugs, announced the completion of pre-IND meeting with the U.S. Food and Drug Administration (FDA) for its lead drug Beta 1. ASG received encouraging feedback, paving the way for the formal IND filing for conducting a Phase I clinical trials in the second half of this year.
Beta1, a novel dry powder inhaler for the treatment of erectile dysfunction, has to date shown better-than-expected results in various clinical evaluations, drug toxicology and pharmacokinetic tests, and preclinical trial planning. Following a successful pre-IND meeting with the FDA, ASG received positive feedback and guidance on further development of clinical trial. ASG will now expedite the revision of clinical trial documents and execute additional test based on FDA's guidance and work toward an IND filing in Q4 2025 and launch Phase 1 clinical trials in Taiwan.
ASG highlighted that existing drugs for erectile dysfunction generally take 40 minutes to 2 hours to reach the peak concentration in the body. Through ASG's core technology, aPPC (Aero-Particles Process Control Technology), improved drug formulation design and inhalation delivery method, Beta1 not only reduces drug absorption time to within 10 minutes but also features the company's specially designed compact, user-friendly, and modern devices, offering a more effective, safer, and convenient therapeutic option for a broader patient population. ASGhas accelerated the development timeline through its core technology. Within just three years, ASG has successfully completed the development of its novel drug Beta1 and will be ready for clinical trials.
About Asia Scientific Global (ASG)
Asia Scientific Global (ASG) is dedicated to the research and development of inhaled novel drug, with a vision of "make the world a better place with every breath". The company focuses on providing patients worldwide with faster, safer, more effective and convenient medical solutions. Expert in the 505(b)(2) pathway, ASG's core advantage lies in its proprietary "Specialized Drug Delivery Platform" based on the aPPC (Aero-Particles Process Control) technology, high-barrier formulation development technology, and innovative medical device development technology. With R&D laboratories in Taiwan and Singapore, and offices and business teams in mainland China, Southeast Asia, and North America, ASG is advancing new product development, clinical trials, and market development.
source: ASG-Asia Scientific Global
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