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Japanese patent extends PrimeC protection to 2042 for NeuroSense (NRSN)

Filing Impact
(Neutral)
Filing Sentiment
(Neutral)
Form Type
6-K

Rhea-AI Filing Summary

NeuroSense Therapeutics reports that the Japan Patent Office has granted Japanese Patent 7857044 covering its lead ALS drug candidate, PrimeC. The patent includes 17 claims and protects PrimeC’s unique extended-release composition and manufacturing process through 2042, including its synchronized delivery of ciprofloxacin and celecoxib.

The company describes this patent as a key part of its global intellectual property portfolio and long-term commercialization strategy in Japan. PrimeC has shown clinical, biomarker, and survival benefits in a Phase 2b ALS study, and NeuroSense has FDA clearance to initiate the pivotal Phase 3 PARAGON trial, expected to enroll about 300 participants.

Positive

  • Japanese patent protection through 2042 for PrimeC’s unique extended-release composition and manufacturing process in a key pharmaceutical market, reinforcing the company’s long-term commercialization strategy for its lead ALS candidate.

Negative

  • None.

Insights

Japanese patent extends PrimeC’s IP runway in a major ALS market.

NeuroSense has secured Japanese Patent 7857044 for PrimeC, protecting its specific ciprofloxacin/celecoxib composition, manufacturing process, and synchronized extended-release profile through 2042. Management highlights Japan as a key pharmaceutical market tied to their long-term commercialization plans.

The patent strengthens a broader global IP portfolio around PrimeC’s multi-target mechanism in ALS, where Phase 2b data showed clinical, biomarker, and survival benefits. The company already has FDA clearance to start the pivotal Phase 3 PARAGON trial in ALS with about 300 participants, primarily in the U.S.

While commercial outcomes remain dependent on Phase 3 results and regulatory approvals, this patent helps secure market exclusivity in Japan for PrimeC’s proprietary formulation over a long horizon, complementing recent patents in the U.S., Australia, and Brazil mentioned alongside this grant.

Japanese patent number Patent 7857044 Issued by Japan Patent Office for PrimeC
Patent term Through 2042 Protection period for PrimeC formulation in Japan
Patent claims 17 claims Coverage for PrimeC’s composition and process
Phase 3 PARAGON enrollment Approximately 300 participants Planned pivotal ALS trial, primarily in the U.S.
ALS annual U.S. diagnoses More than 5,000 people Yearly ALS diagnoses in the United States
ALS annual disease burden $1 billion Estimated annual ALS burden in the U.S.
Projected ALS prevalence growth 24% Expected increase in people living with ALS by 2040 in U.S. and EU
ALS survival after diagnosis 2–5 years Typical course of amyotrophic lateral sclerosis
PrimeC financial
"PrimeC, NeuroSense’s lead drug candidate for the treatment of amyotrophic lateral sclerosis (ALS)."
extended-release formulation technical
"our synchronized extended-release formulation"
An extended-release formulation is a medicine designed to release its active ingredient slowly over an extended period instead of all at once, like a timed sprinkler that waters a lawn gradually rather than flooding it. For investors, it matters because this design can improve patient convenience and adherence, support premium pricing, extend commercial life versus immediate-release versions, and create different regulatory and competitive dynamics that affect sales and profitability.
Phase 3 pivotal study (PARAGON) financial
"preparing for initiation of a Phase 3 pivotal study (PARAGON)."
microRNAs technical
"including microRNAs, supporting PrimeC’s multi-target mechanism of action."
microRNAs are tiny pieces of genetic material that act like dimmer switches for genes, turning down the production of specific proteins inside cells. Investors pay attention because microRNAs can be used as diagnostic markers or drug targets—meaning discoveries can create new tests, treatments, or business opportunities, and progress or setbacks in that research can materially affect a company’s clinical prospects and valuation.
forward-looking statements regulatory
"This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties."
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
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Learn about SEC filing dates

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16

Under the Securities Exchange Act of 1934

 

For the Month of June 2026

 

Commission File Number: 001-41084

 

NeuroSense Therapeutics Ltd.
(Translation of registrant’s name into English)

 

NeuroSense Therapeutics Ltd.

11 HaMenofim Street, Building B
Herzliya 4672562 Israel
+972-9-7996183
(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

 

Form 20-F ☒   Form 40-F ☐

 

 

 

 

 

Explanatory Note

 

On June 9, 2026, NeuroSense Therapeutics Ltd. issued a press release entitled “NeuroSense Therapeutics Receives Japanese Patent Grant for PrimeC Novel Composition.” A copy of the press release is furnished herewith as Exhibit 99.1.

 

The first two paragraphs of the press release attached hereto as Exhibit 99.1 are hereby incorporated by reference into the registrant’s Registration Statements on Form S-8 (File No. 333-262480 and 333-289658) and Form F-3 (File No. 333-269306, 333-260338, 333-283656, 333-284051, 333-291122 and 333-293060) to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

 

1

 

 

Exhibit Index

 

Exhibit No.   Description
99.1   Press Release dated June 9, 2026

 

2

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  NeuroSense Therapeutics Ltd.
     
Date: June 9, 2026 By:  /s/ Alon Ben-Noon
    Alon Ben-Noon
    Chief Executive Officer

 

3

 

Exhibit 99.1

 

NeuroSense Therapeutics Receives Japanese Patent Grant for PrimeC Novel Composition  

 

Patent Protection Extends Through 2042 following recent U.S., Australia and Brazil patents

 

CAMBRIDGE, Mass., June 9, 2026 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense” or the “Company”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that the Japan Patent Office has issued a Japanese Patent 7857044 covering the Company’s lead drug candidate for the treatment of amyotrophic lateral sclerosis (ALS).

 

 

The patent, entitled “Compositions comprising ciprofloxacin and celecoxib,” includes 17 claims and provides protection through 2042 for the unique formulation and manufacturing process of PrimeC, including its synchronized delivery profile of celecoxib and ciprofloxacin, designed to target multiple key mechanisms underlying ALS progression.

 

“This patent grant further strengthens our global intellectual property estate around PrimeC and reinforces the novelty of our synchronized extended-release formulation,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “Japan is a key pharmaceutical market, and this patent further supports our long-term commercialization strategy as we advance PrimeC toward a pivotal Phase 3 clinical trial.”

 

The patent is part of NeuroSense’s broader global IP portfolio protecting both the composition and formulation of PrimeC, which is designed to modulate multiple disease-relevant mechanisms, including neuroinflammation, iron dysregulation, autophagy, and miRNA pathways.

 

PrimeC has demonstrated consistent clinical, biomarker, and survival benefit in the Phase 2b PARADIGM study, including a significant survival benefit in extended follow-up analyses. The Company has received FDA’s clearance to proceed and is preparing for initiation of a Phase 3 pivotal study (PARAGON).

 

The Japanese patent is expected to provide long-term protection for PrimeC’s proprietary formulation in a key strategic market, subject to standard terms and potential extensions.

 

 

 

About NeuroSense

 

NeuroSense Therapeutics is a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease. The Company’s lead product candidate, PrimeC, is a novel oral therapy designed to target multiple key biological pathways underlying disease progression, including neuroinflammation, oxidative stress and dysregulated iron metabolism.

 

NeuroSense has generated compelling clinical data from its Phase 2b PARADIGM study in ALS, demonstrating meaningful slowing of disease progression. The Company also reported significant biological activity across multiple biomarkers associated with ALS, including microRNAs, supporting PrimeC’s multi-target mechanism of action. Notably, long-term follow-up data indicated a meaningful survival benefit, representing a potentially important advancement in the treatment of ALS.

 

NeuroSense has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a pivotal Phase 3 clinical trial (PARAGON) in ALS, which is expected to enroll approximately 300 participants, primarily in the United States.

 

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.

 

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 and AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS and AD.

 

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.

 

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. Further, certain forward-looking statements, including statements regarding the benefits of the Japanese patent, development, regulatory progress and potential commercialization of PrimeC, 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 uncertainty regarding the benefits of the Japanese patent; outcomes and the timing of current and future clinical trials; timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; 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 March 31, 2026 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.

 

 

FAQ

What did NeuroSense Therapeutics (NRSN) announce regarding its Japanese patent?

NeuroSense announced that the Japan Patent Office granted Patent 7857044 for PrimeC. The patent covers its ciprofloxacin/celecoxib composition, manufacturing process, and synchronized extended-release profile, providing protection through 2042 in Japan.

How long does the new Japanese patent protect NeuroSense’s PrimeC formulation?

The Japanese patent provides protection for PrimeC’s proprietary formulation and manufacturing process through 2042. This long duration supports NeuroSense’s stated long-term commercialization plans for PrimeC in Japan as part of its broader global intellectual property portfolio.

What stage of development is NeuroSense’s PrimeC ALS program in?

PrimeC is in late clinical development for ALS. NeuroSense reports consistent clinical, biomarker, and survival benefit from its Phase 2b study and has received FDA clearance to initiate a pivotal Phase 3 trial called PARAGON in ALS.

How many participants are expected in NeuroSense’s Phase 3 PARAGON ALS trial?

The pivotal Phase 3 PARAGON trial is expected to enroll approximately 300 participants. NeuroSense states that the study will enroll primarily in the United States and follows earlier Phase 2b data showing clinical, biomarker, and survival benefits in ALS.

What is PrimeC, NeuroSense Therapeutics’ lead product candidate?

PrimeC is a novel extended-release oral formulation combining ciprofloxacin and celecoxib in a fixed-dose. It is designed to target multiple ALS and Alzheimer’s disease mechanisms, including neuroinflammation, iron dysregulation, oxidative stress, and RNA-related pathways, to potentially slow disease progression.

What disease areas is NeuroSense (NRSN) targeting with PrimeC?

NeuroSense is developing PrimeC primarily for amyotrophic lateral sclerosis (ALS) and also studying it in Alzheimer’s disease. The company describes PrimeC as aiming at multiple disease-relevant pathways, with Phase 2b ALS data indicating clinical and survival benefits and biomarker activity.

Filing Exhibits & Attachments

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