Theratechnologies Announces 48-Week Efficacy and Safety Results for Ibalizumab Presented at IDWeek 2017™

Theratechnologies (TSX:TH) has announced 48-week efficacy and safety results for ibalizumab in patients infected with multidrug resistant HIV-1 that completed the 24-week Phase III study (TMB-301) and continued treatment in the Expanded Access Program study (TMB-311).
As quoted in the press release:

These data are being presented in an oral presentation at IDWeek 2017™ in San Diego (abstract #1686).
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,” said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc. “With the dramatic progress made over the past two decades in treating HIV, the crucial need for new treatments for these very vulnerable patients is often overlooked. At Theratechnologies, focusing on these unmet needs is what we are committed to doing, and ibalizumab is a prime example of that. We thank both the patients and investigators for participating in this important study.”

Click here to read the full press release.