CHINA—AusperBio Therapeutics and Ausper Biopharma (collectively AusperBio), a clinical-stage biopharmaceutical company operating in the USA and China, have gained breakthrough therapy designation (BTD) in China for their investigational drug, AHB-137.
This significant designation, granted by China’s National Medical Products Administration (NMPA), aims to expedite the development and review process for AHB-137, providing new hope for patients suffering from hepatitis B (CHB).
The breakthrough designation was awarded based on positive clinical data from two parallel trials that assessed the drug’s safety and efficacy in treating CHB.
Specifically, one Phase I/IIa trial was conducted in China, while another Phase I trial was carried out outside of China.
These trials demonstrated promising results, highlighting AHB-137’s potential as a new therapeutic option for CHB patients.
AHB-137 has been developed using AusperBio’s Med-Oligo ASO technology platform. This innovative platform has enabled the creation of an unconjugated antisense oligonucleotide designed to achieve a functional cure for CHB.
The drug’s dual-mechanism approach has shown considerable potential in preclinical studies, further bolstering its prospects as an effective treatment.
Currently, AHB-137 is undergoing a Phase Ib trial at multiple international sites and a Phase II trial in China, reflecting the company’s commitment to advancing this promising therapy.
Bella Lu, Regulatory Affairs Director at AusperBio, emphasized the importance of the BTD, noting that it provides the Center for Drug Evaluation (CDE) with expedited review status for AHB-137.
This designation facilitates timely communication and accelerates the approval process, thereby addressing critical clinical needs more efficiently.
Lu pointed out that while the Breakthrough Therapy Designation (BTD) does not alter the product approval standards, it significantly hastens the regulatory process, enabling faster access to potentially life-saving treatments.
Expressing her delight at the NMPA’s grant of breakthrough therapy designation for AHB-137, Lu remarked that this approval underscores the promising clinical data collected so far and highlights the urgent need for substantial advancements in CHB treatment options.
She reiterated that the recognition by the NMPA is a testament to the hard work and dedication of the AusperBio team in developing AHB-137.
Lu concluded by highlighting the outstanding safety and efficacy results from their Phase I/IIa studies. These findings suggest that AHB-137 has the potential to significantly improve upon current HBV therapies.
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