NeuroSense Therapeutics Granted Key U.S. Patent for Novel PrimeC Formulation, its Lead Asset for ALS and Alzheimer's

Rhea-AI Summary

NeuroSense Therapeutics (Nasdaq: NRSN) announced the issuance of a pivotal U.S. patent for its novel PrimeC formulation, a leading drug candidate for treating Amyotrophic Lateral Sclerosis (ALS) and Alzheimer's. The patent, titled 'Compositions comprising Ciprofloxacin and Celecoxib' (US Patent No. US 12,097,185), extends PrimeC's intellectual property protection by an additional four years, now covering it until 2042. PrimeC combines ciprofloxacin and celecoxib in unique doses with a slow-release technology to enhance therapeutic synergy and efficacy. Recent clinical findings showed PrimeC reduced disease progression by 36% and improved survival rates by 43% compared to placebo. NeuroSense CEO Alon Ben-Noon emphasized the innovative formulation's potential to optimize ALS treatment.

Positive

• Newly granted U.S. patent extends PrimeC's protection to 2042.
• PrimeC demonstrated a 36% reduction in ALS disease progression.
• 43% improvement in survival rates compared to placebo.

Negative

• None.

Insights

Biotech Patent Expert

This patent grant significantly strengthens NeuroSense's intellectual property portfolio for PrimeC, their lead ALS treatment candidate. The extension of patent protection to 2042 provides a longer runway for market exclusivity, which is important in the pharmaceutical industry. The patent covers not just the combination of ciprofloxacin and celecoxib, but also the specific formulation and method of use, creating a robust barrier to potential competitors.

The slow-release technology to synchronize pharmacokinetic profiles is a key innovation. This approach could potentially enhance efficacy and reduce side effects, addressing common challenges in drug development. The recent clinical findings showing a 36% reduction in disease progression and 43% improvement in survival rates are particularly promising, especially for a devastating condition like ALS where treatment options are

For investors, this patent grant reduces the risk of early generic competition and potentially increases the value of PrimeC as an asset. It also demonstrates NeuroSense's commitment to protecting its innovations, which is essential for attracting partnerships or potential acquirers in the future.

Neurodegenerative Disease Specialist

The development of PrimeC represents a novel approach to treating ALS, a condition with effective therapies. The combination of ciprofloxacin (an antibiotic) and celecoxib (an anti-inflammatory) in a synchronized, slow-release formulation is intriguing. This approach targets multiple pathways involved in ALS pathogenesis, potentially offering a more comprehensive treatment strategy.

The reported 36% reduction in disease progression is particularly noteworthy. In ALS, where the goal is often to slow the disease course, this level of improvement could translate to meaningful quality of life benefits for patients. The 43% improvement in survival rates is even more striking, as extending life expectancy is a critical unmet need in ALS care.

However, it's important to note that these results need to be replicated in larger, phase 3 trials. The ALS field has seen promising early results fail to translate in larger studies before. Nevertheless, if these results hold up, PrimeC could represent a significant advance in ALS treatment, potentially becoming a new standard of care.

• The Company's intellectual property now covers the combination, formulation, and method of use of PrimeC
• Patent protection extends through 2042, adding four additional years to PrimeC's IP umbrella

CAMBRIDGE, Mass., Sept. 24, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced the issuance of a pivotal patent by the United States Patent and Trademark Office (USPTO). The newly granted patent, entitled "Compositions comprising Ciprofloxacin and Celecoxib" (US Patent No. US 12,097,185), relates to the novel formulation of PrimeC, NeuroSense's leading drug candidate for the treatment of Amyotrophic Lateral Sclerosis (ALS). This patent is expected to extend PrimeC's patent  protection by an additional four years, until 2042.

PrimeC is composed of ciprofloxacin and celecoxib, two FDA-approved compounds in unique doses, formulated in a technology of slow release to synchronize their pharmacokinetic (PK) profiles and enhance their therapeutic synergy. This innovative approach is designed to optimize the treatment efficacy in slowing ALS progression.

The patent grant follows NeuroSense's 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 commented: "PrimeC is more than a combination of two FDA-approved compounds - it's an innovative formulation that synchronizes their pharmacokinetics to unleash their full therapeutic potential. The synergy between ciprofloxacin and celecoxib is designed to maximize efficacy, pushing the boundaries of what's possible in ALS treatment."

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 unexpected R&D costs or operating expenses, 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 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.

Logo - https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg

View original content:https://www.prnewswire.com/news-releases/neurosense-therapeutics-granted-key-us-patent-for-novel-primec-formulation-its-lead-asset-for-als-and-alzheimers-302257091.html

SOURCE NeuroSense

FAQ

What recent patent was granted to NeuroSense Therapeutics?

NeuroSense Therapeutics was granted a U.S. patent for its novel PrimeC formulation, extending protection until 2042.

How does PrimeC improve ALS treatment?

PrimeC combines ciprofloxacin and celecoxib in unique doses with slow-release technology, enhancing therapeutic synergy and efficacy.

What were the clinical findings for PrimeC?

PrimeC demonstrated a 36% reduction in ALS disease progression and a 43% improvement in survival rates compared to placebo.

What is the significance of PrimeC's patent extension?

The patent extension to 2042 provides additional intellectual property protection, potentially increasing PrimeC's market value and longevity.