Results from the Phase 3 trial of Theratechnologies’ (Theratechnologies Stock Quote, Chart, News: TSX:TH, Nasdaq:THER) ibalizumab have Mackie Research Capital analyst André Uddin feeling bullish about the company.
This morning, Theratechnologies reported that it had been notified by partner TaiMed Biologics of the preliminary results for the safety and efficacy secondary end points of the 24-week phase III trial with ibalizumab in patients with multidrug resistant (MDR) HIV-1 (TMB-301) (human immunodeficiency virus). The trial, says management, confirmed confirms the safety and efficacy results of ibalizumab observed in the previously completed phase IIb study, despite the fact that the patient population in the phase III trial had higher levels of MDR HIV-1 and more-advanced disease at time of enrolment.
“We are very pleased with the safety and efficacy results observed in the phase III trial,” said Dr. Christian Marsolais, PhD, senior vice-president and chief medical officer of Theratechnologies. “These results support the submission of the biologics licence application (BLA) to the U.S. FDA, and the next step is the completion of the regulatory submission by our partner TaiMed Biologics,” added Dr. Marsolais.
Uddin says this is solid data that demonstrates great efficacy and safety, and says he expects the product launch of Ibalizumab in the second half of 2017 will be “transformative” for Theratech. He characterized the Phase 3 trial.
“Investors should note that this Phase 3 trial enrolled very sick HIV-1 MDR (multi-drug resistant) patients – as they were resistant to more than 75% of all drugs in the NRTI, NNRTI and PI classes and to 1-2 drugs in the INI class,” says Uddin. “In the Phase 3 trial, after 24 weeks of treatment the mean viral load was 1.6 log10 and a total of 48% of patients had more than a 2.0 log10 reduction. 43% of patients had undetectable viral load (HIV-1 less than 50 copies/mL, mean viral load reduction was 3.1 log10). 53% of patients had viral load less than 400 copies/mL coming from baseline levels of 100,287 copies/mL – we believe the efficacy is excellent for this patient population.”
In a research update to clients today, Uddin maintained his “Buy” rating on Theratechnologies, but raised his one-year price target on the stock from $5.30 to $8.00, implying a return of 157 per cent at the time of publication.
Uddin expects Theratechnologies will generate revenue of $36.5-million in fiscal 2016. He thinks the company’s topline will increase to $56.5-million the following year and climb again to $99.8-million in fiscal 2018.
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