Abstract Details

Title Study Design and Baseline Characteristics in Phase 2 Studies of Elezanumab, a Potential Neurorestorative Therapy for Multiple Sclerosis

Topic Multiple Sclerosis

Presentation(s) MS and CNS Inflammatory Disease Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 082

Objective Present the study design and updated baseline characteristics from two ongoing phase 2 studies investigating elezanumab in patients with progressive (PMS) and relapsing multiple sclerosis (RMS).

Background

There is an unmet need for MS treatments that reverse demyelination and neuronal degeneration and improve function. Elezanumab is a monoclonal antibody that neutralizes the neurite outgrowth inhibitor, repulsive guidance molecule A (RGMa), and may promote neurorestoration and neuroprotection.

Design/Methods RADIUS-R (NCT03737851) and RADIUS-P (NCT03737812) are RAndomized, Double-blind, placebo-controlled, multIple-dose phase 2 stUdies investigating efficacy and Safety of elezanumab added to the standard of care in patients with MS. Subjects were randomized 1:1:1 to receive 1 of 2 doses of elezanumab or placebo intravenously every 4 weeks through week 48. The primary endpoint is the mean overall response score (ORS; based on Expanded Disability Status Scale [EDSS], Timed 25-Foot Walk [T25FW], and 9-hole Peg Test [9HPT]-dominant and nondominant) at week 52. To assess ecologically valid physical activity and mobility, subjects wear 3 biosensors during the waking hours for 7-day intervals at baseline and weeks 24, 36, and 52.

Results

Currently, 208 patients are enrolled in RADIUS-R (96% RRMS, 4% secondary- progressive MS [SPMS]) and 123 in RADIUS-P (48% PPMS, 52% SPMS). Mean (standard deviation [SD]) ORS components for RADIUS-R were: T25FW, 7.3 (4.0); 9HPT-dominant, 28.0 (22.5); and 9HPT-nondominant, 30.0 (23.5); EDSS (median), 3.5; RADIUS-P were: T25FW, 12.5 (11.2); 9HPT-dominant, 31.4 (27.6); and 9HPT-nondominant, 38.1 (37.3); EDSS, 6.0. Most patients used concomitant DMTs (RADIUS-R, 75%; RADIUS-P, 69%). All subjects completed baseline 7-day biosensor wear, and some have completed Week 52; compliance with biosensor wear has been greater than 93%.

Conclusions

RADIUS-R and RADIUS-P are phase 2 studies investigating safety and efficacy of elezanumab, including ecologically valid physical activity measured with wireless biosensors.

Authors/Disclosures
Bruce A. Cree, MD, PhD, MAS, FAAN (UCSF, Multiple Sclerosis Center) PRESENTER	The institution of Dr. Cree has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. The institution of Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. The institution of Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. The institution of Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for TG Therapeutics. The institution of Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Cree has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neuron23. Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Pharma. Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Hexal/Sandoz. Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunic AG. The institution of Dr. Cree has received research support from Genentech. The institution of Dr. Cree has received research support from Kyverna. Dr. Cree has received publishing royalties from a publication relating to health care.
Adam Ziemann, MD, PhD (Eli Lilly)	Dr. Ziemann has received personal compensation for serving as an employee of AbbVie. Dr. Ziemann has received stock or an ownership interest from AbbVie.
Kimberly Pfleeger	Ms. Pfleeger has received personal compensation for serving as an employee of AbbVie. Ms. Pfleeger has stock in AbbVie.
	No disclosure on file
Annette Wundes, MD, FAAN (University of Washington)	The institution of Dr. Wundes has received research support from Benaroya Research Institute .
Mark S. Freedman, MD, FAAN (University of Ottawa)	Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Actelion(Janssen/J&J). Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BiogenIdec. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS/Celgene. Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Inc. Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Actelion (Janssen/J&J). Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Atara Biotherapeutics. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Bayer Healthcare. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for BiogenIdec. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Clene Nanomedicine. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GRI Bio. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Magenta Therapeutics. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck Serono. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Genzyme. Dr. Freedman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi Genzyme. Dr. Freedman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. The institution of Dr. Freedman has received research support from Sanofi Genzyme.

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