Acorda Announces Safety and Tolerability Data from First Clinical Trial of Remyelinating Antibody in Multiple Sclerosis

Were encouraged by the outcome of this trial, which showed that rHIgM22 was well-tolerated at all of the dose levels we studied, said Anthony Caggiano, M.D., Ph.D., Acordas Senior Vice President of Research and Development. We are currently developing the protocol for our next Phase 1 clinical trial of rHIgM22. The data from this study will help inform the design of the next trial, which will enroll people with MS who are experiencing an active relapse.

This was a multi-center, double-blind, randomized, placebo-controlled study designed to evaluate safety, tolerability, pharmacokinetics, and immunogenicity of a single dose of rHIgM22 in participants with any type of MS who were clinically stable for at least three months. All participants remained on their existing MS treatment regimens, including disease-modifying therapies.

The first part of the study included five cohorts, with each cohort receiving a higher dose of rHIgM22 than the previous one. Each cohort consisted of 10 participants (eight receiving drug, two receiving placebo), who were followed for three months after receiving a single dose of study medication. In the second part of the study, 21 treatment-nave participants were randomized to receive placebo or one of the two highest doses of rHIgM22 from the first part of the study. These participants were followed for six months to assess safety and tolerability. The second part of the study also included several exploratory clinical, imaging and biomarker measures, which are still being analyzed. The study was not powered to determine statistical significance on these measures.

Additional details from the trial will be presented at future medical meetings.

Safety Findings

Across all of the study groups, 55 participants received one of the five doses of rHIgM22 and 17 received placebo (no sample size power calculation was used to determine the number of participants in each group). There were no dose-limiting toxicities and no serious adverse events (SAE) in any of the five rHIgM22 dose levels in the study. There was one SAE of squamous cell carcinoma in a placebo-treated participant.

The most commonly observed adverse events (>5% in the combined rHIgM22 treatment groups) reported in the study were: headache, contact dermatitis, multiplesclerosisrelapse, infusionsitehematoma, fatigue, arthralgia, backpain,muscularweakness, neckpain, paininan extremity, pruritus, contusion, and flushing. No participants withdrew due to adverse events.

No safety signals were identified by standard clinical MRI evaluations, or standard clinical, laboratory or ECG assessments.

About MS and rHIgM22

Multiple sclerosis (MS) is a chronic, usually progressive disease in which the immune system attacks and degrades the function of nerve fibers in the brain and spinal cord by destroying myelin (a process known as demyelination) and eventually the nerve fibers themselves. Myelin is a fatty layer of membranes that insulates nerves, facilitating the transmission of electrical impulses through nerve pathways that control all neurological functions. In people with MS, disruption in neurological function often leads to impairments in movement, bowel/bladder function, vision and sexual function.

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Acorda Announces Safety and Tolerability Data from First Clinical Trial of Remyelinating Antibody in Multiple Sclerosis