Theratechnologies (TSX:TH) presented positive 48-week efficacy and safety results at the IDWeek 2017 conference in San Diego for ibalizumab in patients infected with multidrug resistant HIV-1, who completed the 24-week Phase 3 study (TMB-301) and continued treatment in the Expanded Access Program study (TMB-311).
Of the 27 patients who completed the 24-week treatment period of TMB-301 in the U.S., all entered TMB-311, where patients continued to receive ibalizumab at 800 mg every 2 weeks for up to 48 weeks.
The virologic suppression observed at week 24 was sustained through week 48; median viral load reduction from baseline was 2.5log10 at weeks 24 and 48. In TMB-311, all 15 patients with an undetectable viral load at week 24 maintained suppression to week 48. Another patient in TMB-311 reached less than 50 copies/mL at week 48 after having a detectable viral load at week 24. A total of 17 patients (63%) achieved a viral load less than 200 copies/mL.
"As we await an FDA decision for ibalizumab, this long-term data reinforces the critical role ibalizumab could have for patients struggling with multidrug resistant HIV," Luc Tanguay, president and CEO, said in a statement.
The drug was well tolerated and no new or unexpected safety concerns emerged between weeks 24 and 48. The Expanded Access Program is ongoing and enrolling patients.
Dr. Brinda Emu, assistant professor of medicine, infectious diseases, Yale School of Medicine, said that seeing sustained virologic response out to 48 weeks is heartening and emphasizes the potential benefit that ibalizumab might bring to HIV patients in need of new treatment options.
Ibalizumab is currently under accelerated review by the FDA following the acceptance of a Biologics License Application on June 30, 2017. The FDA target action date to complete the review of ibalizumab is Jan. 3, 2018.