ENHANCE trial testing simplified Briumvi dosing now fully enrolled
New regimen would require just 1 starting dose for patients with relapsing MS
Enrollment is complete for the randomized part of ENHANCE, a large clinical trial testing a new dosing schedule for Briumvi (ublituximab-xiiy) in adults with relapsing forms of multiple sclerosis (MS), developer TG Therapeutics announced.
This part of the Phase 3b ENHANCE study (NCT05877963) is specifically testing whether an initial 600 mg dose of Briumvi delivers the same amount of medication to the bloodstream as the approved two-dose regimen. Under the current schedule, patients receive a 150 mg dose on the first day and then a 450 mg dose two weeks later.
Early data have already shown that the consolidated dosing schedule is well tolerated by patients who have never received treatment or have switched from another approved medication.
“We are excited to announce the completion of enrollment in the randomized [part] of the ENHANCE Phase 3 trial, which opened for enrollment last quarter,” Michael S. Weiss, chairman and CEO of TG, said in a company press release.
TG said Briumvi already provides a convenient option for patients, noting that treatment infusions are given every six months and in as little as one hour.
Still, “we remain deeply committed to continuing to enhance the overall patient experience with Briumvi,” Weiss said, adding that “if the data are positive, this new dosing regimen could be ready for launch in 2027,” Weiss said.
In MS, immune cells such as B-cells drive an inflammatory attack that damages nerve cells in the brain and spinal cord, leading to a range of symptoms. Briumvi works by inhibiting CD20, a protein on the surface of B-cells, causing their death and preventing them from taking part in this attack.
Briumvi approved in US as treatment for adults with relapsing MS
Briumvi is approved in the U.S. for adults with relapsing forms of MS, ranging from clinically isolated syndrome — a first attack of MS-like symptoms — to relapsing-remitting MS and active secondary progressive MS. It has been shown in clinical trials to prevent relapses, reduce the formation of brain lesions, and slow the progression of the neurodegenerative disease.
Now, Briumvi is started with an intravenous, or into-the-vein, infusion of 150 mg over four hours, followed by an hour-long infusion of 450 mg two weeks later. Subsequent doses are then given via hour-long 450 mg infusions, administered every six months.
Briumvi’s one-hour infusion duration already offers best-in-class convenience among available [intravenous] anti-CD20s and this represents an important step toward making treatment even more convenient for patients and more efficient for infusion centers.
ENHANCE is assessing the safety and effectiveness of a modified Briumvi regimen that’s expected to be more convenient for people with MS. The trial is being conducted in two parts.
The first part involved patients who were receiving other approved CD20 inhibitors, such as Ocrevus (ocrelizumab), and transitioned to Briumvi. However, these individuals skipped the initial 150 mg infusion, and received the recommended 450 mg dose through either a one- or two-hour infusion.
Data showed that patients reported few and only mild infusion-related reactions, and that most completed the infusion without slowing or stopping treatment.
In the second part, the goal is to test a dosing schedule that combines the first two doses into one, which could make the treatment even more convenient. To do this, researchers are comparing the area under the curve — a measure of the body’s total exposure to the medication — for the approved versus the simplified dosing schedule after 16 weeks, or about four months.
Patients in this part are randomly assigned to receive one of two dosing schedules. One group is being given the approved 150 mg dose, followed by a 450 mg dose two weeks later, while the other receives a 600 mg dose and a placebo two weeks later. Participants in both groups are given the 450 mg dose at week 24, or shortly before the six-month mark.
In addition to comparing the area under the curve for Briumvi over the first 16 weeks, the researchers will also monitor infusion-related reactions for up to 48 weeks, or nearly one year, and watch for changes in lesions with active inflammation.
“Briumvi’s one-hour infusion duration already offers best-in-class convenience among available [intravenous] anti-CD20s and this represents an important step toward making treatment even more convenient for patients and more efficient for infusion centers,” Weiss said.
About the Author
