TEL AVIV, Israel, Aug. 31, 2026
NeuroSense Therapeutics Ltd. announced an accelerated and capital-efficient development strategy for PrimeC, its investigational combination therapy being developed for the treatment of amyotrophic lateral sclerosis (ALS). The company said the updated strategy is intended to advance PrimeC toward a potential regulatory filing while reducing development costs and shortening the timeline required to generate additional clinical evidence. The approach follows discussions with regulatory authorities and is designed to leverage existing clinical data while addressing the requirements for a potential future approval pathway.
NeuroSense Plans Accelerated PrimeC Development
PrimeC is an investigational oral formulation combining ciprofloxacin and celecoxib, two existing medicines that are being evaluated together for their potential effects on multiple biological pathways implicated in ALS. NeuroSense has developed the combination with the objective of addressing disease mechanisms associated with neuroinflammation, RNA metabolism and neurodegeneration rather than targeting a single pathway. The company said its accelerated strategy is intended to build on the clinical evidence generated through the PARADIGM Phase 2b study, which evaluated PrimeC in people living with ALS. Results from the study provided evidence supporting further development of the investigational therapy and contributed to the company’s regulatory strategy. Under the revised development approach, NeuroSense aims to generate the additional evidence needed to support a potential New Drug Application (NDA) submission in the United States. The company emphasized that PrimeC remains investigational and that regulatory approval has not been granted.
Phase 3 Program Designed to Support Registration
A central element of NeuroSense’s strategy is the planned Phase 3 clinical development program for PrimeC. The company intends to design the program around a registration-focused approach, with the objective of producing data that could potentially support regulatory review. The development strategy is expected to make use of information already generated from previous clinical studies, potentially reducing the amount of new development work required compared with a conventional large-scale development pathway. NeuroSense said the strategy is intended to be capital efficient, allowing the company to advance PrimeC while carefully managing the resources required for late-stage clinical development. ALS is a progressive and fatal neurodegenerative disease characterized by the degeneration of motor neurons responsible for controlling voluntary muscle movement. As the disease progresses, patients can experience increasing muscle weakness, impaired mobility, difficulty speaking and swallowing, and respiratory complications. The limited number of effective treatment options and the rapid progression of the disease underscore the need for additional therapeutic approaches. NeuroSense believes PrimeC’s multi-target mechanism could potentially address several biological processes involved in ALS. However, the ability of the therapy to improve long-term outcomes remains subject to confirmation in further clinical studies.
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PrimeC Strategy Targets Unmet ALS Needs
The updated development plan represents an important step in NeuroSense’s efforts to move PrimeC from mid-stage clinical development toward potential registration. The company said the approach is intended to accelerate development while maintaining a focus on generating clinically meaningful evidence. The strategy also reflects the broader pharmaceutical industry’s increasing interest in repurposing established active ingredients through combination approaches to address complex neurological diseases. Because ciprofloxacin and celecoxib have established clinical histories individually, PrimeC’s development focuses on evaluating their combined therapeutic potential and formulation in ALS. NeuroSense said it will continue engaging with regulatory authorities as it advances the program and works toward defining the clinical and regulatory requirements for a potential approval application. The company is also evaluating opportunities to support the continued development and commercialization of PrimeC through strategic partnerships. For patients and the ALS research community, additional late-stage clinical data will be important to determine whether PrimeC can deliver a meaningful benefit in disease progression and patient outcomes. PrimeC has not been approved for the treatment of ALS, and its safety and efficacy will require confirmation through additional clinical and regulatory evaluation. The company’s accelerated, capital-efficient strategy nevertheless marks a significant development in its ALS program and underscores its objective of advancing PrimeC toward a potential approval pathway while addressing the substantial unmet medical need faced by people living with this devastating neurodegenerative disease.
Source: NeuroSense Therapeutics press release
