PrimeC

NeuroSense is a small company based in Israel and Cambridge, Massachusetts, and PrimeC is its only drug. It is financially fragile: in mid-2026 it reported about $231,000 in cash, it is fighting to keep its Nasdaq listing, and it says the large Phase 3 trial needs outside funding that has taken longer than expected to find. A partnership with an unnamed big pharma company, announced as a term sheet in December 2024, has not been finalised.

Ciprofloxacin is an antibiotic that in lab studies affects how cells process RNA (genetic messages), and celecoxib is an anti-inflammatory painkiller. Together they are meant to hit several things that go wrong in ALS at once: inflammation, oxidative stress, iron build-up and faulty RNA handling. The company also reports that PrimeC lowered TDP-43, the protein that clumps in nerve cells in almost all ALS, in blood-based measurements.

The Phase 2b PARADIGM trial is finished, and no Phase 3 trial has started. In November 2025 the FDA allowed the company to start a Phase 3 trial called PARAGON (about 300 people, 12 months), but it has not enrolled anyone because the money to run it has not been secured. The company is now redesigning it to be smaller and shorter, possibly with a head-to-head comparison against edaravone. Separately it plans to ask Health Canada for approval based on the Phase 2b data.

In PARADIGM, 68 people took PrimeC or placebo for 6 months, then everyone took PrimeC. At 6 months, the only placebo-controlled comparison, the difference in the ALS functional score (ALSFRS-R) was 2.2 points and not statistically significant. At 18 months, people who started PrimeC first were 7.9 points better off than those who started on placebo, and a later company analysis reports a 65% lower risk of death. These come from the open-label period, compare small groups (45 vs 23 people), and the survival analysis has only been released by the company, so a larger trial is needed to confirm any benefit. The trial's main goals were safety and a blood marker (TDP-43).

This is the most favourable result reported. See all key studies for the full picture.

PARADIGM enrolled adults with sporadic or familial ALS, who could keep taking riluzole or edaravone. The redesigned Phase 3 plan would preferentially enrol people earlier in their disease, and the new NfL analysis suggested larger effects in people with higher starting function.

NeuroSense said on 2 November 2026 that it will file in March 2027 instead of December 2026 so it can add a new neurofilament (NfL) analysis. If Health Canada accepts the file, a standard review takes about 300 days, so a decision would not come before 2028. The company also expects a decision on a grant to fund Phase 3 in Q1 2027.

No PrimeC trial is enrolling right now, and we found no ClinicalTrials.gov record for PARAGON yet. In October 2026 the company signed an agreement aiming to sell PrimeC to eligible patients through a licensed clinic in one US state, using a pathway that allows some investigational drugs before approval, with first sales targeted for the first half of 2027. Details such as the state and eligibility have not been published.

• PARADIGM (Phase 2b) (NCT05357950) completed · Canada, Israel, Italy
• PARAGON (Phase 3, planned) not yet recruiting · Mainly USA (planned)