48-week efficacy reults Theratechnologies Announces 48-Week Efficacy and Safety Results for Ibalizumab Presented at IDWeek 2017™
HIV Monoclonal Antibody and Long-Acting Investigational Antiretroviral Ibalizumab with Optimized Background Regimen Maintained High Viral Suppression and was Well Tolerated Through Week 48 in Patients with Multidrug Resistant HIV
MONTREAL, QUEBEC--(Marketwired - Oct. 4, 2017) - Theratechnologies Inc. (Theratechnologies) (TSX:TH) today announced 48-week efficacy and safety results for ibalizumab in patients infected with multidrug resistant HIV-1 who completed the 24-week Phase III study (TMB-301) and continued treatment in the Expanded Access Program study (TMB-311). 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."
In TMB-311, ibalizumab plus optimized background regimen (OBR) was well tolerated; of the 27 patients in the study, 24 (89%) continued to receive treatment until week 48 and 3 patients discontinued early due to non ibalizumab-related reasons. No new or unexpected safety concerns emerged between weeks 24 and 48. The most common adverse reactions were diarrhea, dizziness, nausea and rash.
"The participants enrolled in the Phase III study were highly treatment experienced with limited antiretroviral options due to drug resistance. As clinicians treating these patients, having access to an agent with a novel mechanism of action was critical," said Dr. Brinda Emu, Assistant Professor of Medicine, Infectious Diseases, Yale School of Medicine, New Haven, CT. "Seeing sustained virologic response out to 48 weeks is heartening and emphasizes the potential benefit that ibalizumab may bring to HIV patients in need of new treatment options."
About Study TMB-311
Of the 27 patients who completed the 24-week treatment period in TMB-301 in the U.S., 27 entered TMB-311, the ibalizumab Expanded Access Program, where patients continued to receive ibalizumab at 800 mg every 2 weeks for up to 48 weeks. Additionally, 59% and 33% of the patients in the study had exhausted at least three or four antiretroviral (ARV) classes, respectively, and 15% had HIV-1 resistant to all approved ARVs.
The Expanded Access Program is ongoing and enrolling patients. For more information about TMB-311 (NCT02707861), please refer to the ClinicalTrials.gov website (www.clinicaltrials.gov) or the study website (www.ibalizumab-eap.com).
TMB-301 was a 24-week open-label study investigating the efficacy and safety of ibalizumab plus OBR in highly treatment experienced patients with multidrug resistant HIV.