NeuroSense Therapeutics Enters Binding Term Sheet to Advance PrimeC for ALS
Rhea-AI Summary
NeuroSense Therapeutics (NRSN) has entered into a binding term sheet with a leading global pharmaceutical company for its ALS treatment drug PrimeC. The agreement includes a substantial upfront payment, funding for Phase 3 clinical trials, milestone payments, and tiered double-digit royalties on annual net sales. The pharmaceutical company will receive exclusive rights to distribute, market, promote, and sell PrimeC in certain key territories, while NeuroSense retains rights in other key markets.
PrimeC is a fixed-dose combination of two FDA-approved drugs, designed to target multiple ALS disease pathways. The company's Phase 2b PARADIGM trial has shown positive safety and efficacy results. The definitive agreement is expected to be finalized in Q1 2025.
Positive
- Secured substantial upfront payment and Phase 3 trial funding from a major pharmaceutical company
- Agreement includes milestone payments and double-digit royalties on net sales
- Phase 2b PARADIGM trial demonstrated positive safety and efficacy results
- Retained rights to PrimeC in certain key territories while partnering for others
Negative
- Final agreement not yet secured, pending definitive agreement in Q1 2025
- Specific financial terms and territory details not disclosed
News Market Reaction
On the day this news was published, NRSN declined 8.09%, reflecting a notable negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
- Binding Term Sheet with a leading global pharmaceutical company includes a substantial upfront payment and funding for the Phase 3 study
- Additionally, milestone payments and double-digit royalties on annual net sales
- The transaction is subject to finalization of a definitive agreement, anticipated in Q1 2025
The binding term sheet outlines substantial financial terms from the pharmaceutical company, including:
- A substantial upfront payment upon signing a definitive agreement,
- Funding for the Phase 3 clinical trial,
- Regulatory and net sales milestone payments, and
- A tiered royalty structure reaching double-digit percentage on annual net sales.
The binding term sheet is subject to finalization of a definitive agreement, anticipated in the first quarter of 2025.
The pharmaceutical company would have an exclusive license to distribute, market, promote, sell and develop PrimeC for ALS in certain key markets, and non-exclusive rights for research and manufacturing for PrimeC for ALS, subject to terms and conditions in the definitive agreement.
PrimeC is a proprietary fixed-dose combination of two FDA-approved drugs, uniquely formulated to enhance bioavailability and provide synergistic effects that target multiple ALS disease pathways. Results from NeuroSense's Phase 2b PARADIGM clinical trial demonstrated positive safety and efficacy, strengthening confidence in its potential to address the urgent unmet medical need in ALS.
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
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
During the first 6 months of the trial, 45 participants were randomized to receive PrimeC, and 23 participants were randomized to receive placebo. This was followed by a 12-month open-label extension with all participants receiving PrimeC in a blinded manner, where neither the participants nor the clinical staff were aware of the initial treatment allocation.
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
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 the terms of license and timing of a definitive agreement or if a definitive agreement is executed at all. 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 a definitive agreement of the license to the global pharmaceutical company will be delayed or not executed at all, or that, if executed, it will not be on terms described above, the risk that contemplated license agreement, if executed, will not lead to the current anticipated benefits to NeuroSense, the risk of a delay in submission by the Company of its regulatory dossier, that regulatory approvals for PrimeC will be delayed or not obtained in
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SOURCE NeuroSense
FAQ
What are the key terms of NeuroSense's (NRSN) PrimeC licensing agreement?
When will NeuroSense (NRSN) finalize the definitive agreement for PrimeC?
What were the results of PrimeC's Phase 2b PARADIGM trial by NRSN?
How is NeuroSense's (NRSN) PrimeC drug formulated for ALS treatment?
Which territories will NRSN retain rights to PrimeC?
