Theratechnologies Inc., yesterday said that its Taipei-based partner TaiMed Biologics Inc., has submitted a biologics licences application with the United States Food and Drug Administration (FDA) for the use of ibalizumab in treating multi-drug resistant Human Immunodeficiency Virus 1 (MDR HIV-1).
If approved, according to the Montreal-based Theratechnologies, “ibalizumab will be the first antiretroviral treatment (ART) with a new mechanism of action to be introduced in nearly 10 years and the only treatment that does not require daily dosing.”
Since HIV multiplies in the body, the virus sometimes mutates to produce drug-resistant strains. When this occurs, HIV medicines that previously controlled a person’s virus may no longer be effective, causing treatment to fail.
Approximately 20,000 to 25,000 North Americans with HIV-1 are currently resistant to at least one drug in three different classes of antiretroviral therapies. Up to 12,000 of these patients experience a virological failure over a period of 48 weeks of treatment, requiring their physician to modify their treatment.
“The BLA submission is an important milestone for patients, physicians and everyone who has worked tirelessly to bring this much-needed medicine to people living with MDR HIV-1,” said Luc Tanguay, president and chief executive officer, Theratechnologies Inc. “This is a significant step toward the expansion of our product portfolio, which reinforces our mission to improve the lives of people living with HIV.”
The ibalizumab BLA is based on data from the phase III TMB-301 study, a single-arm, 24-week study of ibalizumab plus an optimized background regimen (OBR) in treatment-experienced patients infected with MDR HIV-1. Full results from the trial were recently presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2017.
Unlike other antiretroviral agents, ibalizumab binds primarily to the second extracellular domain of the CD4+ T cell receptor, away from major histocompatibility complex II molecule binding sites. It potentially prevents HIV from infecting CD4+ immune cells while preserving normal immunological function.
Ibalizumab has received “breakthrough therapy” designation from the FDA, which is given if a therapy may provide a substantial improvement over what is currently available to address a serious and life-threatening condition. The FDA also granted “Orphan Drug” designation.
“While some people can suppress their viral loads with currently approved treatments, there is an urgent need for new options among those with multidrug resistance,” said Christian Marsolais, Ph.D., senior vice president and chief medical officer, Theratechnologies.