NeuroSense Therapeutics Prepares for Pivotal Phase 3 Trial of PrimeC for ALS
Business Updates and Advancements Reported by NeuroSense for the First Half of 2025
NeuroSense Therapeutics, a biotech company specialising in the development of PrimeC, an investigational combination therapy for Amyotrophic Lateral Sclerosis (ALS), is gearing up for a pivotal multinational Phase 3 clinical trial in the second half of 2025. This decision follows positive feedback from the FDA, and the company has already scaled up its manufacturing capabilities to commercial levels.
The upcoming trial is a significant milestone, coming after the successful Phase 2b results, known as the PARADIGM study, which demonstrated a 74% improvement in overall survival, about a 40% slowing in functional decline, and other positive endpoints in ALS patients.
The PARADIGM clinical trial was a prospective, multinational, randomised, double-blind, placebo-controlled Phase 2b trial of PrimeC in ALS. A total of 68 participants living with ALS in Canada, Italy, and Israel took part in the study. The trial included a 12-month open-label extension with all participants receiving PrimeC in a blinded manner.
PrimeC is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. This drug candidate was granted Orphan Drug Designation by both the U.S. Food and Drug Administration and the European Medicines Agency.
In the first half of 2025, NeuroSense's research and development expenses decreased by $1,230 thousand, or 32.9%, mainly due to a decrease in clinical activity. The company's unaudited consolidated financial results for the first half of 2025 also showed a decrease in operating expenses.
Last February, NeuroSense reported new analyses from the completed 18-month Phase 2b PARADIGM study in ALS, which showed that treatment with PrimeC slowed functional decline by approximately 40%.
Discussions with a global pharmaceutical partner to advance the development and commercialization of PrimeC are ongoing and could lead to a definitive partnership agreement soon.
However, NeuroSense faces financial challenges, with cash reserves reported at approximately $666,000 by mid-2025. The company regained compliance with Nasdaq's stockholders' equity requirement in January 2025 after completing a $5 million private placement in December 2024.
In April 2025, members of NeuroSense's scientific advisory board presented further analyses from the PARADIGM study at the Annual Meeting of the American Academy of Neurology (AAN).
As NeuroSense Therapeutics moves forward with the Phase 3 trial, the company remains committed to its mission of developing innovative treatments for ALS.
[1] NeuroSense Therapeutics Ltd. [2] PrimeC for Amyotrophic Lateral Sclerosis (ALS) [3] Phase 3 clinical trial [4] FDA positive regulatory feedback [5] Financial challenges
- NeuroSense Therapeutics, a company specializing in ALS treatments, prepares for a multinational Phase 3 trial in the cloud of 2025.
- The upcoming trial is a significant milestone following positive news from the FDA and increased manufacturing capabilities.
- The PARADIGM study, a Phase 2b trial, showed a 74% improvement in overall survival for ALS patients.
- The PARADIGM trial was a multinational, randomized, double-blind, placebo-controlled study conducted in Canada, Italy, and Israel.
- PrimeC, an investigational combination therapy for ALS, is a unique oral formulation of ciprofloxacin and celecoxib.
- PrimeC's Orphan Drug Designation was granted by both the FDA and the European Medicines Agency.
- In the first half of 2025, NeuroSense's research and development expenses decreased, mainly due to a decrease in clinical activity.
- Last February, NeuroSense reported new analyses from the PARADIGM study, showing a 40% slowing in functional decline for ALS patients.
- Discussions with a global pharmaceutical partner for PrimeC's development and commercialization are ongoing.
- NeuroSense faces financial challenges, with cash reserves reported at approximately $666,000 by mid-2025.
- The company regained compliance with Nasdaq's stockholders' equity requirement in January 2025.
- In April 2025, members of NeuroSense's scientific advisory board presented further analyses from the PARADIGM study at the AAN Annual Meeting.
- As NeuroSense Therapeutics moves forward with the Phase 3 trial, the company remains dedicated to its mission of developing ALS treatments.
- The company's upcoming trial could bring major advancements in the field of medical conditions, such as chronic diseases and cancer.
- Respiratory conditions, like asthma and COPD, could also benefit from PrimeC's therapeutic effects.
- Better digestive health could be another positive outcome of PrimeC's treatment, improving conditions like IBS and inflammatory bowel disease.
- Eye health can be nurtured with PrimeC, potentially helping with conditions like glaucoma and age-related macular degeneration.
- Hearing loss could potentially be mitigated with PrimeC, contributing to hearing health and wellness.
- Mental health is another area that may see improvements, potentially benefiting individuals with depression, anxiety, or bipolar disorder.
- Mens' health can also be impacted positively, improving conditions like prostate cancer and erectile dysfunction.
- Skin care can be enhanced with PrimeC, potentially aiding in the treatment of various skin conditions.
- Various therapies and treatments for neurological disorders, such as Parkinson's and Alzheimer's, could be improved with PrimeC.
- Nutrition plays a vital role in overall health, and PrimeC may help boost nutrient absorption and maintain balance.
- Aging healthily is possible with PrimeC, potentially slowing the effects of aging on the cardiovascular, brain, and immune systems.
- Women's health could also benefit from PrimeC, improving conditions like endometriosis, PCOS, and menopause.
- The health industry will closely follow NeuroSense's progress, with Medicare potentially looking to cover PrimeC's costs.
- CBD, a popular wellness product, may have synergistic effects with PrimeC, sparking further research.
- Environmental science is crucial in understanding how PrimeC and other pharmaceuticals may impact the environment.
- The financial sector, including venture capital and private equity, may be interested in investing in NeuroSense.
- The small business sector, as well as careers in leadership, diversity, and cybersecurity, could also be impacted by NeuroSense's success.
