IC14 for ALS Patients Expanded Access

Summary

The primary objective is to provide the investigational product, IC14, at the dose of 8 mg/kg intravenously every 2 weeks for 12 weeks to 6 participants with amyotrophic lateral sclerosis (ALS). No clinical hypotheses are being tested. An extension for 6 additional doses every 2 weeks will be allowed if the drug is safe and well tolerated.A second extension for 14 doses every 2 weeks will be allowed if the drug is safe and well tolerated.

Timeline

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Publications

• Results Gelevski D, Addy G, Rohrer M, Cohen C, Roderick A, Winter A, Carey J, Scalia J, Yerton M, Weber H, Doyle M, Parikh N, Kane G, Ellrodt A, Burke K, D'Agostino D, Sinani E, Yu H, Sherman A, Agosti J, Redlich G, Charmley P, Crowe D, Appleby M, Ziegelaar B, Hanus K, Li Z, Babu S, Nicholson K, Luppino S, Berry J, Baecher-Allan C, Paganoni S, Cudkowicz M. Safety and activity of anti-CD14 antibody IC14 (atibuclimab) in ALS: Experience with expanded access protocol. Muscle Nerve. 2023 May;67(5):354-362. doi: 10.1002/mus.27775. Epub 2022 Dec 30.

Drugs

Indications