Abrax Japan, Inc., a clinical stage biotechnology company developing thymic stromal lymphopoietin (TSLP)-based novel therapies for various ailments with highly unmet medical needs, announced that the company is on track for a First-in-Human clinical trial in Australia. Abrax has completed, with positive results, all the preclinical safety studies, including a Good Laboratory Practices (GLP) dermal toxicity test in mini pigs, that were mandated by the U.S. Food and Drug Administration, using a prototype product, ABX-919.
Based on the results of the GLP mini pig dermal toxicity study, Abrax’s product showed minimal skin reactions upon topical application to 10% body surface area for twenty-eight consecutive days. No histopathological abnormalities in the internal organs were observed. The systemic exposure of the drug was also limited, which is ideal based on the mode of action of the active pharmaceutical ingredient (API) in stimulation of keratinocytes for TSLP production. Other IND-enabling studies demonstrated no issues with photo-toxicity as well as skin sensitivity.
“The successful completion of IND-enabling studies has well positioned us to advance our lead asset towards the clinic,” said Jo Narita, Chief Executive Officer. “We are extremely pleased to see the positive safety profile of ABX-919 in in vitro and in vivo models. Since the completion of the IND-enabling studies, we have been diligently optimizing the prototype formulation to further improve the safety and efficacy. We firmly believe that our product can become a truly valuable and breakthrough treatment for chronic hand eczema patients around the world with limited treatment options.”
Abrax is planning to file for a First-in-Human clinical trial in chronic hand eczema, which is set to initiate in Australia in 2023.