GeNeuro Reports 2020 Full-Year Results and Provides Corporate Update - Seite 2

PRODUCT DEVELOPMENT HIGHLIGHTS SINCE JANUARY 1, 2020

Multiple Sclerosis (MS)

On February 18, 2021, GeNeuro announced it had completed the patient recruitment in its ProTEct-MS temelimab Phase 2 MS trial at the Karolinska Institutet’s Academic Specialist Center (ASC). Despite an initial three-month launch postponement due to COVID-19, GeNeuro and its partners were able to make up half the delay in this study.

By targeting the fundamental underlying mechanisms of neurodegeneration in MS, i.e. neutralizing microglial-mediated damage, as well as restoring OPC¹ remyelination capacity, temelimab may address the critical unmet medical need of blocking disability progression independent of relapses in MS.

On March 2, 2021, GeNeuro also announced that its Phase 2 MS trial at the Karolinska Institutet was cleared to continue following the planned Data Safety Monitoring Board Meeting and its confirmation that higher doses of temelimab of up to 54 mg/kg in the ProTEct-MS Phase 2 study are well tolerated

Amyotrophic Lateral Disease (ALS)

GeNeuro continues its preclinical development program for its pHERV-K Env antibody in the ALS indication in partnership with the National Institute of Neurological Disorders and Stroke (NINDS), part of the U.S. National Institutes of Health (NIH). After some COVID-19 linked delays, the Company has initiated partnering discussions with the objective to seek an IND (Investigational New Drug) from the FDA by 2022 to bring a novel, highly promising therapeutic option to ALS patients.

COVID-19

In January 2021, the Company announced it had received a French state grant to accelerate research into the role of HERV proteins in COVID-19. Preliminary findings showed that proteins of the HERV-W family, with known pro-inflammatory and neurodegenerative properties, may be used by SARS-CoV-2 as an accelerant, which would bring new light in understanding syndromes associated to COVID-19 as well as a new opportunity to treat some of its worst consequences

Should the ongoing research confirm the early findings, GeNeuro’s temelimab could be made immediately available for a therapeutic intervention against the severe acute and post infection neurological consequences of COVID-19. Temelimab is a monoclonal antibody designed to neutralize the pathogenic envelope protein of HERV-W and has already proven its excellent tolerability in Phase 2 trials. This would provide a new, variant-independent, tool for the treatment of SARS-CoV-2-infected patients. New results from the research at leading academic centers are expected to be communicated during Q2 2021.