03 February 2015 | News | By BioSpectrum Bureau
Abivax initiates Ph IIa clinical trial of HIV drug
ABX464 is the candidate molecule for HIV treatment
Singapore: Abivax, a leading clinical stage biotech company developing and commercializing anti-viral compounds and human vaccines, has initiated the enrolment of HIV positive patients for a phase IIa clinical trial of ABX464.
ABX464 inhibits the biogenesis of viral RNA required for the replication of the HIV virus. In pre-clinical reference models of HIV, ABX464 demonstrated its ability to induce a substantial reduction in viral load that persists for weeks after treatment arrest.
Abivax highlighted that with current HIV treatments, the virus starts multiplying again as soon as the drugs are withdrawn, which typically means daily, life-long treatment for patients. ABX4646 needs to be administered less frequently over a shorter period than standard treatments, providing the potential to reduce healthcare costs and offer broader access to treatment.
Professor Mark Wainberg, former president, International AIDS Society, said, "If these unique features of ABX464 are confirmed in the clinical development program in HIV patients that is now underway, ABX464 could become the central element of a functional cure for AIDS."
The randomized, double-blind placebo-controlled clinical study, which is being conducted in Mauritius, is the first one of ABX464 in HIV patients and is designed to assess the safety and efficacy of the compound. It follows the successful completion of a Phase I clinical study in human volunteers in December 2014, which demonstrated that ABX464 was generally safe and well tolerated and had a favourable pharmacokinetic profile.
The study aims to allow ABIVAX to narrow the dose and frequency of administration for the subsequent clinical phase IIb study development planned for the second half of 2015.
Professor Hartmut Ehrlich, CEO, ABIVAX, said, "We are pleased with the progress we are making with ABX464, and we are confident that 2015 will be a pivotal year for this flagship product. We look forward to reporting the data from this Phase IIa study, particularly ABX464's ability to produce a sustained reduction in viral load. With its unique mode of action, ABX464 could dramatically improve the treatment options for patients with HIV."
Professor Tazi added, "Our platform targeting viral messenger RNA is a new approach in blocking the reproduction of a virus. It provides us with several very promising candidate molecules against HIV and other human pathogenic viruses."
ABX464 is the first candidate molecule coming from ABIVAX's proprietary technology platform and chemical library. It has been generated from an in-depth understanding of the processing of viral RNA within the human host cell and the ability of compounds from its novel library to block the biogenesis of viral RNA.