What is the drug thought to do in the body?
PrimeC is a combination of two existing prescription medicines, an antibiotic called Ciprofloxacin and a non-steroidal anti-inflammatory agent called Celecoxib. It is thought to target three key biological features of MND; inflammation in the brain, abnormal microRNA activity (small RNA molecules help to control the activity of other genes) and the build-up of iron in neurons. All of these features have been suggested to contribute to the damage and death of motor neurons in MND. Reducing inflammation, abnormal microRNA activity and iron build-up may reduce the damage to neurons and slow disease progression.
Trial Outcome
The phase 2b (PARADIGM trial) found that PrimeC was safe, well tolerated and showed promising signs of slowing disease progression after six months. Results found that those treated with PrimeC experienced slower disease progression, as measured by the ALSFRS-R scale, and a slower decline in lung function, compared with those on placebo. However, these differences failed to reach statistical significance. Post-hoc analysis (completed after the study ended) has potentially identified a subgroup of people from the trial that demonstrated statistically significant slowing in disease progression compared to placebo. Further research would be needed to confirm these findings. You can read the press release of the top-line results here.
Previous Clinical Trials
Phase 1
A phase 1 trial was looking at the safety and tolerability of PrimeC in healthy people. It also assessed how the drug moved into, through, and out of the body and how it interacted with food. Results showed that the treatment was safe and well-tolerated by healthy participants. You can read more about this trial here.
The other phase 1 trial was assessing the safety and tolerability of PrimeC in people with MND. Prime C was found to be safe and well tolerated by people with MND after 12 months of treatment. You can read more about this trial here.
Phase 2a
The phase 2a trial was an open label trial, meaning that everyone on the trial received PrimeC and there was no placebo. The aim of the trial was to determine if the drug was safe and showed signs of benefit for people with MND. The trial showed that the drug was safe and well tolerated and showed signs of slowing disease progression as measured by the ALSFRS-R and lung function tests, although this was not statistically significant. You can find out more about this trial here.
Phase 2b (PARADIGM)
The phase 2b trial was a randomised, double blind, placebo controlled trial. It was looking to investigate the efficacy and safety of PrimeC, measured by monitoring the effects of the drug and if there were changes in the ALSFRS-R for people on the potential treatment. Participants were either given PrimeC or placebo twice a day for 6 months. Once participants completed the 6 month trial, they had the option of taking part in an open label extension where everyone on the trial could receive PrimeC for a year. You can read more about the trial here. This trial recruited participants in Canada, Israel and Italy.
Latest News
2024
October 2024- Neurosense, the company behind PrimeC, have announced that they are meeting with the FDA to discuss plans for a Phase 3 trial of the drug to test it further. You can read more about this here.
October 2024- Neurosense, the company behind PrimeC, have begun an application to Health Canada for marketing approval for PrimeC. You can read more here.
July 2024- Data from the Open label extension period of the phase 2b trial was announced. This found that participants given PrimeC for the full year showed significantly slower disease progression than those who started it six months later. You can read more about this data here.
May 2024- Further analysis of data from the Phase 2b trial found that PrimeC might be able to significantly slow disease progression in certain subgroups of participants. PrimeC was found to slow disease progression more for people on the trial who were newly diagnosed or who had a higher risk of rapid disease progression. You can read more here.
April 2024- Additional biomarker results from the Phase 2b trial announced. The results showed that treatment with PrimeC reduced levels of a biomarker of disease called Neurofilament light chain in the blood. You can read more here.
2023
December 2023- Top-line results of Phase 2b trial were announced in a press release.
May 2023- Phase 2b (PARADIGM) trial is fully enrolled.
2022
June 2022- First participant is enrolled in Phase 2b (PARADIGM) trial.
Last updated: 19/11/2024