AiViva Biopharma Announces Positive Data from Phase 1/2a Clinical Trial of AIV001 for Dermal Scarring and Wound Healing
NEWPORT BEACH, Calif., June 25, 2020 (GLOBE NEWSWIRE) -- AiViva Biopharma Inc., a clinical-stage biotechnology company developing innovative therapies to address major unmet medical needs, today announced completion of its first Phase 1/2a study evaluating AIV001 in dermal scarring. A total of 16 subjects who were scheduled to undergo abdominoplasty were enrolled and completed in one of the four double-blind dose escalation or open label cohorts. Incisional wounds on the abdomen received a focal intradermal treatment of AIV001 or vehicle on Days 1 and 21, or not treated as a control, and the wound healing was monitored for 49 days post-wounding. Our results showed that AIV001 was well tolerated by intradermal treatment as compared to the vehicle. No serious local or systemic side effects were observed in the subjects at any of the doses administered. Transient local skin reactions were observed at high doses and resolved by the end of the tudy.
A pharmacokinetics analysis showed prolonged drug residence around the treated incisional wound with very low systemic exposure detected. Histological evaluation of the incisional wounds showed reduction in fibrosis within 7-10 days post wounding following AIV001 treatment. These data were consistent with nonclinical minipig studies that show AIV001 delayed granulation and reduced fibrosis formation. There was no noticeable difference in the healing among untreated, vehicle treated, and AIV001 treated wounds by clinical and photographic examination.
“We are very excited about the results,” said Dr. Diane Tang-Liu, President and CEO of AiViva. “These clinical data confirm AiViva’s intradermal AIV001 treatment may have significant clinical utility by modulating the aberrant scarring typically associated with excessive granulation and fibrosis during the wound healing process.” Dr. Tang-Liu added that, “Scarring has been a significant issue that can cause debilitating aesthetic, functional and psychological effects. There are no FDA-approved therapeutics for treatment of post-operative scars, therefore, AIV001 has the potential to be a transformative treatment in this space.”
About AiViva Biopharma, Inc.
AiViva is a clinical stage biotech company led by a team of seasoned industry experts with proven track record in drug development and commercialization. AiViva has developed innovative approaches to address high unmet medical needs by transforming treatment paradigms through focal therapies. Core competencies include development of novel drugs using proprietary technologies, including JEL™, in specialty therapeutic areas of dermatology, ophthalmology, urology and oncology. Our lead products, AIV001 and AIV007, are designed to optimize therapeutic outcomes and lower treatment burden by targeting diseases of neovascularization, abnormal cell proliferation, and fibrosis. Please visit www.aiviva.com to learn more.