TG Therapeutics subcutaneous Briumvi matches IV exposure in MS trial

TG Therapeutics (NASDAQ:TGTX) announced positive data from a Phase 1 clinical trial evaluating a high-concentration subcutaneous formulation of its multiple sclerosis therapy Briumvi (ublituximab-xiiy).

The findings demonstrate that an injectable version of the drug can match the therapeutic exposure of the currently approved intravenous infusion, potentially simplifying administration for patients.

Pharmacokinetic and pharmacodynamic modeling from the study indicates that either quarterly or every-other-month subcutaneous injections can achieve a 24-week drug exposure non-inferior to the standard intravenous regimen.

The investigational formulation demonstrated a mean bioavailability of greater than 60%, with no new or unexpected safety signals observed during the trial.

The study evaluated more than 100 patients who received a cumulative total of more than 225 subcutaneous injections.

The data showed that the subcutaneous route achieved a level of B-cell depletion consistent with the approved intravenous administration.

The localized treatment was generally well tolerated by participants, providing the clinical rationale for the specific dosing schedule selected for later-stage testing.

These early results validate the 400 mg/2 mL quarterly dosing regimen that TG Therapeutics has advanced into definitive testing.

The drugmaker confirmed that the pivotal Phase 3 trial evaluating this subcutaneous protocol is now fully enrolled.

Top-line data from that advanced clinical study is expected to be released around late 2026 to early 2027.