A planned Phase 2 clinical trial of a potential treatment for progressive multiple sclerosis has been postponed to keep hospital resources open to treat people with COVID-19 during the ongoing global outbreak, and to reduce the risk of exposure to MS patients, GeNeuro, the investigate therapy’s developer, announced.
The clinical trial is expected to evaluate temelimab (formerly GNbAC1) in up to 40 people whose disease is progressing without relapses at a single site, the Karolinska Institutet, a medical university in Stockholm.
GeNeuro hopes to fully enroll the study by year’s end, allowing it to move forward.
“This postponement is a logical and necessary decision to reduce the demands on healthcare professionals, prioritize treatment of COVID-19 patients, and safeguard the wellbeing of MS patients,” Jesús Martin-Garcia, CEO of GeNeuro, said in a press release.
“We must put the fight against COVID-19 and the safety of MS patients first,” Martin-Garcia added. “Initiation of the trial will now take place once hospitals have more capacities for clinical research, and are able to ensure that MS patients will not be put at risk.”
This one-year trial intends to build on the results of two previous studies of temelimab in people with relapsing-remitting MS: the Phase 2 CHANGE-MS trial (NCT02782858) and its extension, the Phase 2b ANGEL-MS (NCT03239860). Both studies reported positive results, including slower disease progression and lesser evidence of brain atrophy in RRMS patients treated with temelimab.
By assessing temelimab in people with progressive form of MS without relapses — of which primary progressive MS and non-active secondary progressive MS are the two types — GeNeuro is looking at a patient group with few treatment options.
The trial plans to test the potential treatment’s safety and tolerability in enrolled patients at increasing dose levels, as well as to measure its efficacy through biomarker analysis.
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