NeuroSense Therapeutics Plans to File for Early Commercialization of ALS Treatment in Canada

Rhea-AI Summary

NeuroSense Therapeutics (NASDAQ: NRSN) has initiated the regulatory process for early commercialization approval of PrimeC, its ALS treatment, under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. This decision follows positive Phase 2b trial results showing PrimeC reduces ALS disease progression by 36% (p=0.009) and improves survival rates by 43% compared to placebo.

The company plans to seek approval in additional countries based on these promising results. NeuroSense CEO, Alon Ben-Noon, expressed confidence in PrimeC's potential to address urgent unmet needs in ALS treatment and the company's commitment to expediting access to this therapy.

Positive

• Phase 2b trial results show 36% reduction in ALS disease progression (p=0.009)
• 43% improvement in survival rates compared to placebo
• Initiation of regulatory process for early commercialization in Canada
• Plans to seek approval in additional countries

Negative

• None.

Insights

Biotechnology Analyst

This news is highly significant for NeuroSense Therapeutics and the ALS treatment landscape. The initiation of the regulatory process for early commercialization in Canada, based on strong Phase 2b results, represents a major milestone. The 36% reduction in disease progression and 43% improvement in survival rates are impressive outcomes in ALS research.

From an investor perspective, this development could potentially accelerate PrimeC's path to market, which is important for a small-cap biotech company with a market cap of just $24.7 million. Early commercialization in Canada could provide:

• Faster revenue generation
• Validation of PrimeC's efficacy
• Real-world data to support approvals in other markets

However, investors should note that regulatory approval is not guaranteed and the company will likely need additional capital to support commercialization efforts. The stock may see increased volatility as the market reacts to this news and anticipates future regulatory decisions.

Medical Research Analyst

The clinical data for PrimeC is noteworthy in the context of ALS treatment. A 36% reduction in disease progression and 43% improvement in survival rates are substantial in a field where effective treatments are scarce. These results, if replicated in larger studies, could position PrimeC as a potential game-changer in ALS therapy.

Key considerations for investors and the medical community:

• The p-value of 0.009 for disease progression reduction indicates strong statistical significance
• Early commercialization through Canada's NOC/c policy could provide valuable real-world evidence
• The multi-pronged approach of PrimeC (targeting neuroinflammation, oxidative stress and iron accumulation) aligns with current understanding of ALS pathology

While promising, it's important to await further data and regulatory scrutiny. The transition from Phase 2b to market approval often reveals additional challenges or nuances in drug efficacy and safety profiles.

• The preparations for the regulatory submission for early commercialization in Canada follows the positive Phase 2b trial results which show PrimeC reduces ALS disease progression by 36% and improves survival rates by 43%
• Company plans to seek approval in additional countries

CAMBRIDGE, Mass., Oct. 9, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ('NeuroSense'), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced it has initiated the regulatory process to seek early commercialization approval for PrimeC under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. This submission is based on the promising results from the company's Phase 2b ALS PARADIGM clinical trial, alongside supporting clinical and preclinical data.

This decision aligns with the recommendations of Canadian regulatory experts and follows recent clinical findings, where PrimeC demonstrated a 36% reduction in disease progression (p=0.009) and a 43% improvement in survival rates compared to placebo, underscoring its potential as a breakthrough therapy for ALS.

Alon Ben-Noon, NeuroSense CEO expressed optimism about the company's prospects: "We are excited to take this important step toward bringing PrimeC to ALS patients in Canada. The compelling results from our clinical trials give us confidence that PrimeC can address the urgent unmet needs in ALS treatment. Our goal is to expedite access to this promising therapy, and we are committed to advancing regulatory approvals in Canada and beyond."

About ALS

Amyotrophic lateral sclerosis ("ALS") is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.

About ALSFRS-R

Disease progression is measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), which is the most widely used ALS tracking tool accepted by the FDA, utilized by neurologists treating ALS patients, in clinical trials, and by other regulators to determine disease progression. It tracks 12 changes in a person's physical abilities over time including functions such as: speech, walking, climbing stairs, dressing/hygiene, handwriting, turning in bed, cutting food, salivation, swallowing, and breathing.  A single point change on the ALSFRS-R has a significant impact on ALS patients, such as the transition from independent feeding to requiring assistance or independent breathing to needing to use a machine ventilator.

About PARADIGM

PARADIGM is a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b (NCT05357950) clinical trial of PrimeC in ALS. The trial included 68 participants living with ALS in Canada, Italy, and Israel. 96% of the trial participants who completed the 6-month double-blind portion of the trial chose to receive treatment with PrimeC through a 12-month open label extension. Furthermore, to date (June 2024) all participants that completed the 18-month trial treatment duration, requested to continue PrimeC, which is provided to them in an Investigator Initiated Trial, not limited with time.

As previously reported, in the 6-month double-blind segment of the trial, the data showed clinically meaningful signs of efficacy with a 29% difference in favor of PrimeC vs placebo in analysis of the intent to treat (ITT) population. In the PP top-line analysis from PARADIGM, a statistically significant slowing of disease progression was observed with a 37.4% (p=0.03) difference in ALSFRS-R in favor of PrimeC vs placebo. Most patients enrolled in both the active and placebo arms of the trial were concurrently treated with Riluzole, the ALS standard of care medication, indicating PrimeC slowed disease progression well beyond the level afforded by the FDA approved ALS drug.   

About PrimeC

PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid ("RNA") regulation to potentially inhibit the progression of ALS. NeuroSense completed a Phase 2a clinical trial which met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC's biological activity. PrimeC was granted Orphan Drug Designation by the U.S. Food and Drug Administration and the European Medicines Agency.

About NeuroSense

NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases.

For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.

Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics' current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding PrimeC as a potential treatment for people with ALS. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the risk that regulatory approvals for PrimeC will not be obtained in Canada or elsewhere; unexpected R&D costs or operating expenses, insufficient capital to complete development of PrimeC, a delay in the reporting of additional results from PARADIGM clinical trial, the timing of expected regulatory and business milestones, risks associated with meeting with the FDA and Health Canada to determine the best path forward following the results from PARADIGM clinical trial, including a delay in any such meeting; the potential for PrimeC to safely and effectively target ALS; preclinical and clinical data for PrimeC; the uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data; the development and commercial potential of any product candidates of Neurosense; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense's filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading "Risk Factors" in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 4, 2024 and NeuroSense's subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.

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SOURCE NeuroSense

FAQ

What are the key results of NeuroSense's Phase 2b ALS PARADIGM clinical trial for PrimeC?

NeuroSense's Phase 2b ALS PARADIGM clinical trial for PrimeC showed a 36% reduction in disease progression (p=0.009) and a 43% improvement in survival rates compared to placebo.

What regulatory action has NeuroSense (NRSN) taken for PrimeC in Canada?

NeuroSense (NRSN) has initiated the regulatory process to seek early commercialization approval for PrimeC under Health Canada's Notice of Compliance with Conditions (NOC/c) policy.

Does NeuroSense plan to seek approval for PrimeC in other countries besides Canada?

Yes, NeuroSense plans to seek approval for PrimeC in additional countries based on the positive Phase 2b trial results.

What is the potential impact of PrimeC on ALS treatment according to NeuroSense?

According to NeuroSense, PrimeC has the potential to address urgent unmet needs in ALS treatment, based on its promising clinical trial results showing reduced disease progression and improved survival rates.