1st Patient Enters ProTEct-MS Extension Trial Testing Higher Temelimab Doses

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by Vanda Pinto PhD |

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The first patient who completed the ProTEct-MS Phase 2 clinical trial assessing temelimab as a treatment for relapsing forms of multiple sclerosis (MS) has entered the trial’s extension part.

In the open-label extension trial, patients will switch to or continue to receive temelimab at least until next spring, when the core trial findings are expected.

“We are grateful to the patients who have agreed to participate in this important study and are delighted to offer them the possibility of continued treatment with temelimab,” David Leppert, MD, chief medical officer of GeNeuro, which is developing the treatment, said in a press release.

Temelimab is a monoclonal antibody designed to target a viral protein, called pHERV-W, and prevent it from causing inflammation and damaging the myelin coat of nerve cells. Myelin is a fatty substance that wraps around nerve fibers for more efficient neuronal communication and is damaged in MS.

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The treatment showed positive results in the CHANGE-MS Phase 2 trial (NCT02782858) and the open-label extension study ANGEL-MS (NCT03239860). In both studies, treatment with an 18 mg/kg dose reduced brain atrophy, helped maintain the integrity of myelin, and reduced disease progression. However, the doses used in these trials were considered “conservative” by researchers.

The ProTEct-MS Phase 2 trial (NCT04480307), conducted at the Karolinska Institutet’s Academic Specialist Center in Stockholm, was therefore designed to investigate higher doses of temelimab in people with relapsing forms of MS.

ProTEct-MS enrolled people with relapsing MS whose disability progressed without relapses following treatment with rituximab, an antibody therapy that destroys a protein on the surface of B-cells (a type of immune cell that causes inflammation in MS), for at least one year.

Participants were randomly assigned to receive one of three temelimab doses (18, 36, or 54 mg/kg), or a placebo, given as monthly bloodstream infusions, for 48 weeks (about one year).

The study’s main goal is to determine the safety and tolerability of temelimab, as reflected by the number of adverse events reported by patients. Other goals include changes in the volume of certain brain regions, number of new and enlarging lesions, and number of lesions with active inflammation.

After the optimal doses of temelimab are determined in the core ProTEct-MS trial, the extension part will continue to gain more insights on long-term neuroprotective effects of the identified doses.

“We look forward to the data of ProTEct-MS in March 2022, as positive results with temelimab would open a new therapeutic option against disability progression, the major unmet medical need in MS,” Leppert said.

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