Phase 2 Trial of Progressive MS Treatment Postponed Due to COVID-19

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by David Melamed, PhD |

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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.

Temelimab is an antibody that targets and neutralizes the human endogenous retrovirus envelope protein, or pHERV-Env, which is thought to be involved in MS development, particularly in attacks on the protective myelin sheath of nerve cells, and in preventing remyelination.

HERV proteins are thought to be derived from viral DNA that has been embedded into the human genome. The activity of these proteins is normally suppressed, but GeNeuro speculates that they may be activated in MS, and potentially in other neurodegenerative and autoimmune diseases.

The company recently announced that it had raised €17.5 million (about $18.7 million) through a select and private sale of stock shares, giving it the operating capital for this Phase 2 progressive MS trial, and to request a first trial in a separate antibody that might treat amyotrophic lateral sclerosis (ALS).

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