VIDEO: Combination therapy showed favorable safety profile in ALS

DENVER — A combination therapy of ciprofloxacin and celecoxib demonstrated a favorable safety profile for those with amyotrophic lateral sclerosis, Merit Cudkowicz, MD, MSc, said in this Healio video.

“The combination treatment was safe, the discontinuation rates were similar between the groups and the side effects were rare, often mild and did not lead to drug discontinuation,” noted Cudkowicz, chair of neurology and director of the Sean M. Healey Center for ALS at Massachusetts General Hospital, said at the American Academy of Neurology annual meeting.

In the phase 2b PARADIGM clinical trial, 68 individuals in the early stages of ALS were randomized 2:1 to receive either PrimeC or placebo for 6 months, with the option to continue treatment in a 12-month open-label extension.

Data showed that safety outcomes were not different between treatment arms. In the treatment group, change in the adjusted ALS Functional Rating Scale (ALSFRS) score was slowed by approximately 29% to 34% compared with the placebo group, Cudkowicz said.

Cudkowicz added that the positive results in the phase 2 trial indicate moving forwards with a phase 3 study is likely.