Phase 3 trial begins for at-home injectable version of Briumvi
Formulation could be more convenient for patients than intravenous infusion
TG Therapeutics has started enrolling participants in a Phase 3 trial to test a new version of Briumvi (ublituximab-xiiy) that can be injected at home. This change could offer greater convenience and flexibility for people with relapsing forms of multiple sclerosis (MS).
The new formulation is given under the skin, or subcutaneously, and is being compared to the approved intravenous (into-the-vein) infusion, which is administered by a healthcare provider.
Briumvi is approved as an hour-long intravenous infusion every six months after initial loading doses. The subcutaneous version is expected to be given more frequently, likely every few months, but patients could self-administer it at home.
The trial will compare two dosing schedules for the subcutaneous version — every 8 weeks and every 12 weeks — to see whether they provide similar exposure to the drug, safety, and effectiveness compared with the intravenous treatment.
Exploring a new formulation
“We are very pleased to announce the commencement of patient enrollment in our Phase 3 trial of subcutaneous Briumvi. This marks an important milestone for TG in our subcutaneous development program,” Michael S. Weiss, TG’s chairman and CEO, said in a company press release.
He added that if the results are positive, the study could support approval of the new formulation as early as 2028.
About 40% of patients with relapsing forms of MS prefer self-injected therapies over infusions, Weiss noted. A subcutaneous version of Briumvi would allow the company to serve both groups: those who value the regular contact with healthcare providers that intravenous infusions provide, and those who prefer the convenience of at-home injections.
“If successful, Briumvi would be the only anti-CD20 therapy to offer an [intravenous] healthcare provider administered option, as well as an at home subcutaneous self-administered option, providing greater flexibility and choice,” Weiss said.
MS is caused by the immune system mistakenly attacking the myelin sheath, a protective coating around nerve fibers, resulting in inflammation and nerve cell damage. B-cells are an immune cell type that plays a key role in driving these autoimmune attacks.
Briumvi is an antibody-based therapy that targets CD20, a protein at the surface of B-cells, thereby decreasing B-cell numbers. It has been shown in clinical trials to significantly reduce disease activity, namely the frequency of relapses and the development of brain lesions, and to slow the progression of disability in people with relapsing forms of MS.
The treatment acts like other anti-CD20 antibodies, but specific sugar molecules attached to the antibody were modified to boost its effectiveness. This enables effective B-cell depletion even at low doses.
TG is also conducting the Phase 3b ENHANCE trial (NCT05877963) to test a modified regimen of Briumvi.
The treatment currently involves two initial infusions, one of which lasts four hours, given two weeks apart, followed by one-hour infusions every six months. However, the trial is exploring whether the first two infusions can be combined and whether subsequent infusions can be given in 30 minutes.
The trial is still recruiting patients at several sites across the U.S. and Poland, and is expected to finish in 2026. Recent data demonstrated that combining the initial infusions of Briumvi was well tolerated by adults with relapsing MS.
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