TGTX News & Events

TG Therapeutics is up 10.6%, or $3.89 to $40.53.

TG Therapeutics announced pharmacokinetic, pharmacodynamic, safety, and tolerability data from its Phase 1 clinical trial evaluating subcutaneous formulation of ublituximab as compared to IV Briumvi. The overall concentration-time profile of subcutaneous Briumvi was consistent with expectations for a subcutaneous formulation, with a gradual absorption phase and lower peak concentrations relative to IV, and linear pharmacokinetics were observed over the entire dose range evaluated. Subcutaneous Briumvi demonstrated mean bioavailability of greater than 60% relative to IV administration, with the lower bound of the 95% confidence interval exceeding 55%. PK modeling and simulation informed by the Phase 1 bioavailability data support the conclusion that: the quarterly subcutaneous dosing regimen that is being evaluated in the Phase 3 trial would achieve non-inferior total drug exposure over 24 weeks with an estimated geometric mean ratio of 1.21, as compared to IV Briumvi. The every other month subcutaneous dosing regimen that is also being evaluated in the Phase 3 trial, would achieve non-inferior total drug exposure over 24 weeks with an estimated GMR of 1.58, as compared to IV Briumvi. The lower bound of the 90% confidence intervals for both dosing regimens being evaluated in Phase 3 would exceed the threshold required to establish non-inferiority, which is the primary endpoint of the ongoing Phase 3 trial. Treatment with subcutaneous Briumvi resulted in B-cell depletion consistent with IV Briumvi, supporting the biological activity of the subcutaneous formulation. Subcutaneous administration was generally well tolerated, with treatment-emergent adverse events consistent with the known safety profile of IV Briumvi. Local injection-site reactions were infrequent, occurring in less than 5% of patients, and systemic injection-related reactions occurred in approximately 21% of patients. Local and systemic injection reactions were not dose dependent and predominantly occurred at the first injection and resolved in 100% of patients. No serious injection-site reactions and no new safety signals were observed. The Phase 1 data, including the observed safety profile and modeled PK results, support the quarterly subcutaneous dosing regimen being evaluated in the Phase 3 trial. The Phase 3 dose of 400 mg in a 2mL injection is consistent with a volume that is suitable for at-home self-administration via an autoinjector device, which will be evaluated in a separate device bridging study to commence later this year. Final data through 24-weeks from this Phase 1 trial are expected to be presented at a future medical meeting.

TG Therapeutics announced the publication of data from a post-hoc pooled analysis of the Phase 3 ULTIMATE I and II studies evaluating Briumvi in treatment-naive adult patients with relapsing forms of multiple sclerosis. The article was published in Frontiers in Immunology. These post-hoc analyses demonstrate that Briumvi provided significant and consistent improvements across multiple clinical and MRI endpoints compared to teriflunomide in patients who had not received a prior disease-modifying therapy, including those treated early in their disease course. These analyses evaluated pooled data from the Phase 3 ULTIMATE I and II trials in patients who had not received prior disease-modifying therapy, including a subset of people treated within three years of symptom onset. Outcomes were assessed over 96 weeks of treatment. Ublituximab reduced annualized relapse rate by 56.7% versus teriflunomide in treatment-naive patients and by 61% in the subpopulation of treatment-naive patients treated within three years of symptom onset. Two-fold greater confirmed disability improvement was observed in treatment-naive patients and 4-fold greater CDI in early-treated patients. Low rates of confirmed disability progression were observed across treatment groups over 96 weeks Ublituximab reduced gadolinium-enhancing T1 lesions by 96.1% and new/enlarging T2 lesions by 90.6% versus teriflunomide in treatment-naive patients. No evidence of disease activity was achieved in 82.7% of treatment naive ublituximab-treated patients versus 23.1% of teriflunomide-treated patients.