- Phase 2b trial showed significant 33% disease progression slowdown and 58% survival improvement
- Potential peak revenue of $100-150M in Canadian market
- Advancing toward early access in Canada through NOC/c pathway
- Binding term sheet with global pharma company under active negotiation
NeuroSense Therapeutics (NASDAQ: NRSN) has recently shared a comprehensive update to its shareholders, emphasizing key progress in its ALS treatment program involving their therapeutic candidate, PrimeC. The Phase 2b PARADIGM study yielded promising results, with a noteworthy 33% slowing in disease progression (p=0.007) and a 58% improvement in survival rates when compared to placebo. These findings underscore the potential impact of PrimeC in altering the course of ALS, a disease notoriously challenging to treat effectively.
The company is preparing to launch a global Phase 3 clinical trial in the latter half of 2025, focusing primarily on sites across the United States and Europe. Additionally, in pursuit of earlier availability in Canada, NeuroSense is engaging with Health Canada under the Notice of Compliance with Conditions (NOC/c) pathway, which could expedite patient access while providing crucial real-world efficacy data. This strategic maneuver is projected to create a significant revenue opportunity, estimated at $100-150 million annually in the Canadian market.
On the partnership front, NeuroSense disclosed its ongoing negotiations with a prominent global pharmaceutical company following a binding term sheet signed in December 2024. While these discussions have taken longer than anticipated due to the complexities of a multi-regional agreement, the company remains optimistic about the potential for a transformative partnership that could bolster their strategic and financial positioning.
The positive momentum in NeuroSense's regulatory and partnership strategies highlights the company's commitment to addressing the unmet needs of ALS patients through innovative therapeutic approaches, while also strengthening its market position and preparing for future growth initiatives.
