Announcement • May 28

Tg Therapeutics Announces Positive Topline Results from Phase 3 Enhance Trial

TG Therapeutics, Inc. issued a press release announcing positive topline results from the Phase 3 ENHANCE trial, a randomized, double-blind study evaluating a consolidated single infusion regimen for initiation of BRIUMVI (ublituximab-xiiy) in adults with relapsing forms of multiple sclerosis (RMS). The trial met its primary endpoint, demonstrating bioequivalent drug exposure between the currently approved initiation dosing regimen of 150 mg on Day 1 and 450 mg on Day 15 and a consolidated single 600 mg infusion on Day 1, eliminating the need for a Day 15 infusion. Topline outcomes from the ENHANCE Phase 3 study are highlighted below, and full results are expected to be presented at an upcoming medical meeting. The Phase 3b ENHANCE trial is a randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the pharmacokinetics, safety, and MRI outcomes of a consolidated first infusion regimen of BRIUMVI. The primary endpoint of the study is to demonstrate bioequivalent overall drug exposure between a single 600 mg Day 1 infusion of BRIUMVI and the currently approved dosing regimen of 150 mg on Day 1 followed by 450 mg on Day 15. Overall drug exposure was measured by area under the serum concentration time curve from baseline through Week 16 (AUC 0-Wk16). AUC values within each treatment arm are summarized using geometric means and then compared between treatment arms using a ratio of those geometric means (GMR). Participants were randomized into one of two treatment arms: the approved BRIUMVI initiation regimen of 150 mg on Day 1 and 450 mg on Day 15; or a new consolidated BRIUMVI initiation regimen of a single 600 mg infusion on Day 1 only and a placebo infusion on Day 15. All subsequent maintenance dosing in both treatment arms followed the currently approved BRIUMVI prescribing information. With both arms receiving the same cumulative dose of 600 mg through Day 15, the study was designed to ensure that comparable drug exposure was achieved across both treatment arms. Secondary endpoints included safety, pharmacodynamics, and efficacy. The trial met its primary endpoint, demonstrating bioequivalence between the new single Day 1 BRIUMVI infusion regimen and the currently approved initiation regimen administered on Days 1 and 15. Total drug exposure over 16 weeks (AUC 0-Wk16) was comparable between treatment arms, with a geometric mean ratio (GMR) of approximately 1.0 and a 90% confidence interval within the protocol-defined bioequivalence range of 0.80 to 1.25. Secondary endpoints, including safety, B-cell depletion, and MRI outcomes, were consistent with prior BRIUMVI clinical studies and comparable between treatment arms through the primary assessment period with no new safety signals observed. Infusion-related reactions in both arms were lower than previously reported in the ULTIMATE I and II approval studies for BRIUMVI, with no Grade 3 or higher infusion reactions occurring in either arm. In addition, infusion-related reactions were statistically indistinguishable between treatment arms in this study with fewer infusion reactions observed in the consolidated single-infusion treatment arm. BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses. BRIUMVI is indicated in the U.S. for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease and in several foreign nations for the treatment of adult patients with RMS with active disease defined by clinical or imaging features. BRIUMVI is contraindicated in patients with active Hepatitis B Virus infection and a history of life-threatening infusion reaction to BRIUMVI. BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization. Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment. Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively.

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