TG Therapeutics (TGTX) Announces Publication of ULTIMATE I and II Phase 3 Trial Results of Investigational Ublituximab

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TG Therapeutics, Inc. (NASDAQ: TGTX), today announced results from Phase 3 ULTIMATE I and II trials evaluating the company’s investigational anti-CD20 monoclonal antibody ublituximab in patients with relapsing multiple sclerosis (RMS), have been published in The New England Journal of Medicine (NEJM). Michael S. Weiss, President and CEO of TG Therapeutics, said, “We are extremely pleased that the results of the ULTIMATE I & II trials have been published in the New England Journal of Medicine. We believe that the novel mechanism of action of ublituximab, combined with the convenience of a one-hour infusion, represents a potential breakthrough for patients with RMS and we are delighted that this publication shares the ULTIMATE I and II with a large audience. We continue to be particularly focused on the potential approval of ublituximab by the PDUFA deadline of December 28, 2022 and, if successful, preparation for launch early next year. We would like to once again thank the patients who participated in ULTIMATE I and II and the site healthcare providers who worked so hard on these trials.

Lawrence Steinman, MD, Zimmermann Professor of Neurology and Neurological Sciences and Pediatrics at Stanford University and Global Study Chair for the ULTIMATE I and II trials, said, “The ULTIMATE trials revealed that the Ublituximab treatment, compared to teriflunomide, produced significantly lower annualized relapse rates, reduction in total number of lesions detectable by MRI, as well as improved rates of patients achieving no evidence of disease activity (NEDA). If approved, the unique attributes of ublituximab, particularly its ability to be infused as a one-hour infusion every six months after the first dose, could provide benefits to patients with relapsing forms of multiple sclerosis. plates.” Key data from the ULTIMATE I & II trials

Primary Endpoint: Annualized Relapse Rate (ARR) Results

• In ULTIMATE I, treatment with ublituximab resulted in an RAR of 0.08 (n=271), versus 0.19 for teriflunomide (n=274), (p
• In ULTIMATE II, treatment with ublituximab resulted in an RAR of 0.09 (n=272), versus 0.18 for teriflunomide (n=272), (p=0.002).

MRI results

• In the ULTIMATE I trial, the mean total number of gadolinium-enhancing lesions by T1-weighted MRI was 0.02 in the ublituximab group and 0.49 in the teriflunomide group (rate ratio, 0.03; CI at 95%, 0.02 to 0.06;P
• In the ULTIMATE I trial, the mean total number of new or expanding hyperintense lesions by T2-weighted MRI was 0.21 in the ublituximab group and 2.79 in the teriflunomide group (rate ratio, 0.08; 95% CI, 0.06 to 0.10, P

Results without proof of disease activity (NEDA)

• In ULTIMATE I, NEDA was observed in 44.6% of patients treated with ublituximab and in 15% of patients treated with teriflunomide. In ULTIMATE II, NEDA was observed in 43% of patients treated with ublituximab and in 11.4% of patients treated with teriflunomide.

Predefined grouped disability results

• In the pre-specified pooled analysis, 5.2% of participants in the ublituximab group had confirmed worsening disability at 12 weeks compared with 5.9% of participants in the teriflunomide group (relative risk, 0.84; 95 CI %, 0.50 to 1.41; P=0.51); 3.3% of participants in the ublituximab group had confirmed worsening disability at 24 weeks, compared with 4.8% of participants in the teriflunomide group (hazard ratio, 0.66; 95% CI, 0.36 to 1, 21). These results were not considered to be significantly different between treatment groups.
• In the predefined pooled tertiary analysis that was not included in the hierarchical analysis and from which no conclusion can be drawn, 12.0% of participants who received ublituximab had a decrease in disability confirmed at 12 weeks, compared to 6.0% of participants who received ublituximab. teriflunomide (relative risk, 2.16; 95% CI, 1.41 to 3.31); 9.6% of participants who received ublituximab had a confirmed decrease in disability at 24 weeks, compared with 5.1% of participants who received teriflunomide (hazard ratio, 2.03; 95% CI, 1. 27 at 3.25).

Safety/tolerance

• In a pooled analysis of the two trials, 486 of 545 participants (89.2%) who received ublituximab and 501 of 548 participants (91.4%) who received teriflunomide had at least one adverse event. Grade 3 or higher adverse events occurred in 116 participants (21.3%) who received ublituximab and 77 (14.1%) who received teriflunomide.
• The most common adverse event associated with ublituximab was infusion-related reactions (47.7% of patients who received ublituximab experienced at least one infusion-related reaction compared to 12.2% for the group teriflunomide).

Based primarily on the results of the ULTIMATE I & II trials, marketing applications for ublituximab to treat patients with RMS have been accepted and are currently under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). As previously announced, ublituximab has been granted a deadline by the FDA (Prescription Drug Fee User Act, PDUFA) of December 28, 2022.