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GeNeuro Announces That a First Patient Having Finished the ProTEct-MS Study at the Karolinska Institutet’s Academic Specialist Center Has Entered the Study Extension

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  • Study extension initiated to offer patients the opportunity to continue receiving temelimab after completing the one-year study

  • Results from ProTEct-MS remain on track for Q1 2022

GENEVA, September 22, 2021--(BUSINESS WIRE)--Regulatory News:

GeNeuro (Euronext Paris: CH0308403085 - GNRO), a biopharmaceutical company focused on stopping causal factors driving the progression of neurodegenerative and autoimmune diseases, such as multiple sclerosis (MS), today announced that a first patient having completed its ProTEct-MS study at Karolinska Institutet’s Academic Specialist Center (ASC) in Stockholm, which tests temelimab at monthly doses of 18, 36 and 54 mg/kg in MS patients, has entered the ProTEct-MS extension.

This extension study aims at providing treatment to all patients who have completed their one-year treatment duration, until the results of the core ProTEct-MS study are available in the spring of 2022. The extension will then continue to gain more data on the anti-neurodegenerative effect of temelimab, based on the optimal dose identified in the core ProTEct-MS study.

"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," said Prof. David Leppert, Chief Medical Officer of GeNeuro. "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."

Temelimab is a monoclonal antibody designed to neutralize a pathogenic retroviral envelope protein, HERV-W ENV. Positive results with temelimab have already been achieved in two clinical studies, CHANGE-MS and ANGEL-MS, using a dose of 18mg/kg.

Patient enrolment into ProTEct-MS was completed in February 2021 with a cohort of 42 patients being treated for 48 weeks with temelimab (18, 36 and 54 mg/kg) vs. placebo. The double-blind placebo-controlled study has been designed to assess safety and efficacy measures based on the latest biomarkers associated with disease progression and will have results in 1Q2022.

Patients included in the study had confirmed disability progression without relapses following previous treatment with the anti-CD20 drug rituximab, a highly potent and efficacious drug against acute disease activity (relapses and brain lesion formation).

About GeNeuro

GeNeuro‘s mission is to develop safe and effective treatments against neurological disorders and autoimmune diseases, such as multiple sclerosis, by neutralizing causal factors encoded by human endogenous retroviruses (HERVs), which represent 8% of human DNA.

GeNeuro is based in Geneva, Switzerland and has R&D facilities in Lyon, France. It has rights to 17 patent families protecting its technology.

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This press release contains certain forward - looking statements and estimates concerning GeNeuro’s financial condition, operating results, strategy, projects and future performance and the markets in which it operates. Such forward-looking statements and estimates may be identified by words, such as "anticipate," "believe," "can," "could," "estimate," "expect," "intend," "is designed to," "may," "might," "plan," "potential," "predict," "objective," "should," or the negative of these and similar expressions. They incorporate all topics that are not historical facts. Forward looking statements, forecasts and estimates are based on management’s current assumptions and assessment of risks, uncertainties and other factors, known and unknown, which were deemed to be reasonable at the time they were made but which may turn out to be incorrect. Events and outcomes are difficult to predict and depend on factors beyond the company’s control. Consequently, the actual results, financial condition, performances and/or achievements of GeNeuro or of the industry may turn out to differ materially from the future results, performances or achievements expressed or implied by these statements, forecasts and estimates. Owing to these uncertainties, no representation is made as to the correctness or fairness of these forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates speak only as of the date on which they are made, and GeNeuro undertakes no obligation to update or revise any of them, whether as a result of new information, future events or otherwise, except as required by law.

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