SEALS First DSMB positive review

Axoltis Pharma is delighted to announce that the 𝗗𝗦𝗠𝗕 completed its first safety assessment of the Phase 2b trial in Amyotrophic Lateral Sclerosis (ALS) and 𝗿𝗲𝗰𝗼𝗺𝗺𝗲𝗻𝗱𝗲𝗱 𝗰𝗼𝗻𝘁𝗶𝗻𝘂𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝘁𝗵𝗲 𝘁𝗿𝗶𝗮𝗹 𝘄𝗶𝘁𝗵𝗼𝘂𝘁 𝗺𝗼𝗱𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻.

𝗦𝗘𝗔𝗟𝗦 is a multi-center, randomized, double-blind, placebo-controlled 𝗣𝗵𝗮𝘀𝗲 𝟮 𝘁𝗿𝗶𝗮𝗹, 𝗲𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗻𝗴 𝗲𝗳𝗳𝗶𝗰𝗮𝗰𝘆 𝗮𝗻𝗱 𝘀𝗮𝗳𝗲𝘁𝘆 𝗼𝗳 𝗡𝗫𝟮𝟭𝟬𝗰. Up to 𝟭𝟲 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗶𝗻𝘃𝗲𝘀𝘁𝗶𝗴𝗮𝘁𝗶𝗼𝗻 𝘀𝗶𝘁𝗲𝘀 to participate and 𝟴𝟬 𝗔𝗟𝗦 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀 to be enrolled (NCT06365216) and enriched through digital twin technology. More than 40 patients have been already randomized.

The Data Safety Monitoring Board (DSMB), composed of 3 independent experts, reviewed safety data on a first cohort of ALS patients and concluded that safety was good and NX210c well tolerated. NX210c is a short peptide, intravenously administrated for 10 minutes, 3 times a week for 4 weeks.

“𝘛𝘩𝘦 𝘱𝘰𝘴𝘪𝘵𝘪𝘷𝘦 𝘰𝘶𝘵𝘤𝘰𝘮𝘦 𝘰𝘧 𝘵𝘩𝘪𝘴 𝘧𝘪𝘳𝘴𝘵 𝘋𝘚𝘔𝘉 𝘳𝘦𝘷𝘪𝘦𝘸 𝘰𝘧 𝘵𝘩𝘦 𝘚𝘌𝘈𝘓𝘚 𝘴𝘵𝘶𝘥𝘺 𝘪𝘯 𝘈𝘓𝘚 𝘱𝘢𝘵𝘪𝘦𝘯𝘵𝘴 𝘴𝘪𝘨𝘯𝘪𝘧𝘪𝘤𝘢𝘯𝘵𝘭𝘺 𝘣𝘶𝘪𝘭𝘥𝘴 𝘰𝘯 𝘵𝘩𝘦 𝘧𝘢𝘷𝘰𝘶𝘳𝘢𝘣𝘭𝘦 𝘴𝘢𝘧𝘦𝘵𝘺 𝘢𝘯𝘥 𝘵𝘰𝘭𝘦𝘳𝘢𝘣𝘪𝘭𝘪𝘵𝘺 𝘱𝘳𝘰𝘧𝘪𝘭𝘦 𝘦𝘹𝘩𝘪𝘣𝘪𝘵𝘦𝘥 𝘣𝘺 𝘕𝘟210𝘤 𝘪𝘯 𝘱𝘳𝘪𝘰𝘳 𝘴𝘵𝘶𝘥𝘪𝘦𝘴 𝘢𝘯𝘥 𝘪𝘴 𝘱𝘢𝘳𝘵𝘪𝘤𝘶𝘭𝘢𝘳𝘭𝘺 𝘪𝘮𝘱𝘰𝘳𝘵𝘢𝘯𝘵 𝘪𝘯 𝘵𝘩𝘪𝘴 𝘷𝘶𝘭𝘯𝘦𝘳𝘢𝘣𝘭𝘦 𝘱𝘰𝘱𝘶𝘭𝘢𝘵𝘪𝘰𝘯” said Dr Annette Janus, MD, Chief Medical Officer of Axoltis Pharma.

“𝘞𝘦 𝘢𝘳𝘦 𝘱𝘭𝘦𝘢𝘴𝘦𝘥 𝘸𝘪𝘵𝘩 𝘵𝘩𝘦 𝘭𝘦𝘷𝘦𝘭 𝘰𝘧 𝘪𝘯𝘷𝘦𝘴𝘵𝘪𝘨𝘢𝘵𝘰𝘳 𝘢𝘯𝘥 𝘱𝘢𝘵𝘪𝘦𝘯𝘵 𝘦𝘯𝘨𝘢𝘨𝘦𝘮𝘦𝘯𝘵, 𝘴𝘩𝘰𝘸𝘯 𝘣𝘺 𝘵𝘩𝘦 𝘷𝘦𝘳𝘺 𝘨𝘰𝘰𝘥 𝘦𝘯𝘳𝘰𝘭𝘮𝘦𝘯𝘵 𝘳𝘢𝘵𝘦 𝘪𝘯 𝘚𝘌𝘈𝘓𝘚, 𝘢𝘯𝘥 𝘢𝘭𝘭 𝘰𝘶𝘳 𝘵𝘦𝘢𝘮’𝘴 𝘢𝘯𝘥 𝘱𝘢𝘳𝘵𝘯𝘦𝘳𝘴’ 𝘥𝘦𝘥𝘪𝘤𝘢𝘵𝘪𝘰𝘯. 𝘛𝘩𝘪𝘴 𝘴𝘩𝘰𝘶𝘭𝘥 𝘦𝘯𝘢𝘣𝘭𝘦 𝘵𝘰 𝘳𝘦𝘭𝘦𝘢𝘴𝘦 𝘵𝘩𝘦 𝘵𝘰𝘱𝘭𝘪𝘯𝘦 𝘳𝘦𝘴𝘶𝘭𝘵𝘴 𝘧𝘰𝘳 𝘘2 2026.” highlighted Dr Yann GODFRIN, Ph.D., Chief Executive Officer of Axoltis Pharma.

Thanks to the coordinating investigator Dr Emilien BERNARD Hospices Civils de Lyon – HCL and all the investigation sites.

Thanks to our partners among them: ARSLA ACT4ALS-MND : Alliance on Clinical Trials for ALS-MND ALSINOVA CRO THERADIS PHARMA Bachem Liof Pharma KCAS Bio Nuvisan Pr Sylvain Lehmann (plateforme PPC) TRICALS VIGIPHARM David Liens RLM Consulting InSilicoTrials

SEALS is partly granted by Région Auvergne-Rhône-Alpes, Préfecture Auvergne-Rhône-Alpes, Bpifrance