Theratechnologies Announces Ibalizumab Inhibits HIV-2 In Vitro

MONTREAL, July 06, 2020 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, is pleased to announce that data presented at the 23rd International AIDS Conference virtual meeting, demonstrates that ibalizumab is active in vitro against group A and group B HIV-2.

Ibalizumab in vitro activity against HIV-2
The objective of the study, conducted by a team of researchers at Bichat-Claude Bernard Hospital and Saint-Antoine Hospital in Paris, France, was to assess the phenotypic susceptibility to ibalizumab of HIV-2 clinical isolates.

Phenotypic assays were performed on 6 HIV-2 clinical isolates (2 group A and 4 group B), 1 ROD HIV-2 group A reference strain and 1 BRU HIV-1 group M reference strain.

Phenotypic susceptibility was assessed through 50 percent inhibitory concentrations (IC50) and Maximum Percent Inhibition (MPI).

Ibalizumab inhibited viral replication in all seven HIV-2 isolates with IC50 ranging from 0.002 to 0.18µg/mL while MPI was below 80 percent in only two strains, between 80 and 90 percent in 1 stain and above 90 percent in 4 strains.

Results obtained in HIV-2 in vitro are similar to those obtained in clinical trials in HIV-1 is available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/0b8b4b7e-7675-41cf-a7c3-b6c7a75be25d

“Based on results obtained in vitro, it is expected that ibalizumab could have some efficacy in patients infected with HIV-2. HIV-2 multidrug resistance is on the rise in Europe and West Africa and there are limited therapeutic options, if any. The results obtained by the team of researchers in Paris are good news to patients with HIV-2 as ibalizumab could become an add-on to an optimized background regimen for people with an uncontrolled HIV-2,” said Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer, Theratechnologies.

HIV-2 is naturally resistant to Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) and to enfuvirtide. In addition, HIV-2 easily develops drug-resistance mutations (DRAMs) to protease, NRTI and integrase inhibitors. Most recent drugs are not recommended for HIV-2 due to lack of efficacy or because they have not been evaluated for HIV-2.

About Ibalizumab
Ibalizumab is a CD4-directed post-attachment HIV-1 inhibitor. In the United States, Ibalizumab, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.

In Europe, Ibalizumab, in combination with other antiretroviral(s), is indicated for the treatment of adults infected with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen.

Ibalizumab is commercialized in the United States and in Europe under the tradename Trogarzo®.  Ibalizumab is not approved for the treatment of HIV-2.

About Theratechnologies
Theratechnologies (TSX: TH) (NASDAQ: THTX) is a commercial-stage biopharmaceutical company addressing unmet medical needs by bringing to market specialized therapies for people with orphan medical conditions, including those living with HIV. Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR at www.sedar.com and on EDGAR at www.sec.gov.

Forward-Looking Information
This press release contains forward-looking statements and forward-looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on our management’s beliefs and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as "may", "will", "should", "could", “would”, "outlook", "believe", "plan", "envisage", "anticipate", "expect" and "estimate", or the negatives of these terms, or variations of them. The forward-looking statements contained in this press release include, but are not limited to, the potential efficacy of ibalizumab in patients infected with HIV-2 and the addition of ibalizumab as an add-on drug to an optimized background regimen for people with an uncontrolled HIV-2.

Forward-looking statements are based upon a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Theratechnologies’ control that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. These assumptions include but are not limited to, the following: results obtained in vitro will be replicated in humans and the development of ibalizumab for the potential treatment of HIV-2 will continue to progress and yield positive results.

The risks and uncertainties include, among others, the fact that in vitro results are not replicated into humans.

We refer potential investors to the "Risk Factors" section of our annual information form dated February 24, 2020 available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov as an exhibit to our report on Form 40-F dated February 25, 2020 under Theratechnologies’ public filings for additional risks regarding the conduct of our business and Theratechnologies. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-looking statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date.

We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.

For media inquiries:
Denis Boucher
Vice President, Communications and Corporate Affairs
514-336-7800

For investor inquiries:
Leah Gibson
Senior Director, Investor relations
617-356-1009

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Results obtained in HIV-2 in vitro are similar to those obtained in clinical trials in HIV-1.

 

Results obtained in HIV-2 in vitro are similar to those obtained in clinical trials in HIV-1.

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