TaiMed Biologics Inc. announced results from Trogarzo Intramuscular (IM) Administration Study. A Phase 3 Study evaluating the safety and trough serum concentration of Trogarzo Administered as an Undiluted IV Push or as an Intramuscular Injection in Clinically Stable HIV-1 Infected Trogarzo Experienced Patients and Healthy HIV-uninfected Volunteers. Study centers and number of subjects: IM group V the study was conducted at 4 study centers in the United States (US).

A total of 21 subjects were enrolled. Objectives (IM portion) Primary: Evaluate the safety of Trogarzo administered as an IM injection in clinically stable human immunodeficiency virus type-1 (HIV-1)-infected subjects with at least 3 months of stable treatment with a Trogarzo-containing (ARV) regimen and in healthy HIV-uninfected volunteers. Compare the trough serum drug concentration after IV infusion with the diluted drug to the trough serum concentration after IM injection of undiluted Trogarzo.

Secondary: Assess HIV-1 viral load for IV infusion compared to IM injection in HIV-1 infected subjects only. Characterize noted HIV-1 sensitivity/susceptibility changes in participants with an increase in plasma viral load to levels above 1,000 copies/mL on 2 consecutive measurements at least 2 weeks apart in HIV-1 infected subjects only. Determine the presence and significance of anti-Trogarzo antibodies, if any (immunogenicity of Trogarzo).

Compare the area under the curve (AUC) after IV infusion with the diluted drug to the AUC after IM injection of undiluted Trogarzo. Phase of development: Phase 3 study in the US. Protocol number: TMB-302.

Study design: 21 subjects received Trogarzo via IV infusion every 2 weeks (q2wk) for 2 doses, and then administered as IM injection q2wk for 4 doses. Results of Clinical Study: The disclosure results of clinical study is derived from the press release from Theratechnologies inc. on October 13, 2023. Mean Trogarzo trough concentrations were greater than 15 £gg/mL, suggesting that IM injection was sufficient at maintaining the drug trough concentration above the therapeutic level of 0.3 £gg/mL.

The mean trough concentrations were comparable between IV infusion and IM injection in HIV-positive subjects. However, the primary endpoint measuring a 90% 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 endpoint, 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, TaiMed marketing partner Theratechnologies inc. 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).

On October 3, 2022, the U.S. Food and Drug Administration (FDA) approved a 30-second Intravenous (¡§IV¡¨) Push method of administration for the maintenance dose of Trogarzo (800mg). In order to further facilitate the administration of Trogarzo, Theratechnologies Inc. filed a supplemental Biologics License Application (sBLA) to the FDA for the IV Push administration of the loading dose of Trogarzo (2000mg). The FDA is currently reviewing the Company¡¦s submission for the loading dose of the TrogarzoR IV push method of administration, and a decision is expected in mid-December.