A phase 2b trial found PrimeC was well tolerated and showed longer-term signals of benefit in ALS
Original source
Safety and Efficacy of PrimeC in Amyotrophic Lateral Sclerosis: The PARADIGM Randomized Clinical Trial. (opens in a new tab)Compass summarised this from the study's abstract.
Study details
- Study type
- Clinical trial
- Studied in
- Human
- Trial registration
- NCT05357950
PrimeC was well tolerated in a randomized, placebo-controlled phase 2b trial involving 68 people with amyotrophic lateral sclerosis (ALS). After six months, the difference in ALS Functional Rating Scale-Revised scores between PrimeC and placebo was not statistically significant. At 18 months, participants who continued PrimeC had better functional scores and fewer composite events, including hospitalization, respiratory failure or death.
Why this matters
The findings support further testing of PrimeC, an oral combination of celecoxib and ciprofloxacin, in a confirmatory trial. They do not yet establish that PrimeC improves ALS outcomes or change treatment, because the longer-term comparison was made during an open-label extension and the study was not powered to test efficacy.
Limitations and context
This was a small, 68-person phase 2b trial at four ALS referral centers, with participants eligible only if disease duration was 30 months or less. The placebo-controlled period lasted six months, while the 18-month results came from an open-label extension in which all participants received PrimeC. The study was not powered for efficacy, and the prespecified neuron-derived exosome TDP-43/prostaglandin J2 analyses were to be reported separately. A larger confirmatory trial is still needed.