Mr. Phillipe Dubuc reports

THERATECHNOLOGIES ANNOUNCES RESULTS FROM TROGARZO(TM) (IBALIZUMAB-UIYK) INTRAMUSCULAR ADMINISTRATION STUDY

Theratechnologies Inc. has released results from a study evaluating an intramuscular (IM) method of administration for Trogarzo (ibalizumab-uiyk), a monoclonal antibody anti-retroviral therapy (ART) for the treatment of heavily treatment-experienced adults with multidrug-resistant (MDR) human immunodeficiency virus Type 1 (HIV-1) infection failing their current anti-retroviral regimen.

The TMB-302 study, conducted in partnership with TaiMed Biologics, enrolled 21 subjects (seven HIV-positive and 14 HIV-negative) to assess the pharmacokinetics, efficacy and safety of IM administration of Trogarzo as compared with intravenous (IV) infusion. Mean Trogarzo trough concentrations were greater than 15 micrograms/millilitre, suggesting that IM injection was sufficient at maintaining the drug trough concentration above the therapeutic level of 0.3 microgram/mL. The mean trough concentrations were comparable between IV infusion and IM injection in HIV-positive subjects. However, the primary end point measuring a 90-per-cent confidence interval of the ratio of IM injection to IV infusion (0.69, 1.08) did not meet the equivalence limits (0.8, 1.25). Viral suppression, a key secondary clinical end point, was maintained in all HIV-positive subjects throughout the IM phase and the overall study.

Each study subject received IM maintenance doses for eight weeks of treatment and a total of 152 IM injections were administered, which were well tolerated. One subject reported injection-site pruritus (itching) at a single time point, and no subjects reported injection-site pain when Trogarzo was administered intramuscularly.

With the TMB-302 data in hand, Theratechnologies is seeking expert advice prior to completing a regulatory submission of the Trogarzo IM administration maintenance dose to the U.S. Food and Drug Administration (FDA). The FDA is currently reviewing the company's submission for the loading dose of the Trogarzo IV push method of administration and a decision is expected in mid-December.

About Trogarzo (ibalizumab-uiyk)

Trogarzo (ibalizumab-uiyk) is a long-acting, CD4-directed, postattachment HIV-1 inhibitor. In the United States, Trogarzo, in combination with other anti-retroviral(s), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current anti-retroviral regimen. Trogarzo is not approved in Canada.

Trogarzo is administered by intravenous infusion as a single loading dose of 2,000 milligrams (mg) followed by a maintenance dose of 800 mg every two weeks after dilution in 250 mL of 0.9 per cent sodium chloride injection, USP. In October, 2022, the Trogarzo maintenance dose was approved by the FDA to also be administered as an undiluted IV push over 30 seconds.

Important safety information

Do not receive Trogarzo if you have had an allergic reaction to Trogarzo or any of the ingredients in Trogarzo. Trogarzo can cause allergic reactions, including serious reactions, during and after infusion. Tell your health care provider or nurse, or get medical help right away if you experience any symptoms of an allergic reaction. Before you receive Trogarzo, tell your health care provider about all of your medical conditions, including if you are pregnant or plan to become pregnant as it is not known if Trogarzo may harm your unborn baby, or if you are breastfeeding or plan to breastfeed as it is not known if Trogarzo passes into breast milk. Tell your health care provider about all the medicines you take, including all prescription and over-the-counter medicines, vitamins and herbal supplements.

Changes in your immune system (immune reconstitution inflammatory syndrome) can happen when you start taking HIV-1 medicines. Your immune system might get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your health care provider right away if you start having new symptoms after starting your HIV-1 medicine. The most common side effects of Trogarzo include diarrhea, dizziness, nausea and rash. Tell your health care provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Trogarzo. For more information, ask your health care provider or pharmacist.

Full prescribing information is available on the Trogarzo website.

About Theratechnologies Inc.

Theratechnologies is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs.

We seek Safe Harbor.