Neurosense plans to license rights to advance PrimeC in certain regions
Phase 3 trial testing ALS therapy in patients expected to launch midyear
Neurosense Therapeutics has entered a binding term sheet with a leading global pharmaceutical company to advance the development and commercialization of PrimeC, its oral therapy for amyotrophic lateral sclerosis (ALS).
The binding term sheet, a preliminary document outlining the terms and conditions of a potential agreement between the two companies, includes funding for a Phase 3 study of PrimeC as well as upfront and milestone payments and royalties. The definitive agreement is expected to be finalized in the next few months, according to a company press release.
The pharmaceutical company was not named in the release, and Neurosense did not disclose any specific dollar amounts, only calling the figures “substantial.”
Under the terms of the agreement, Neurosense “would retain full rights to PrimeC in other key territories” not indicated, the release states.
Per collaboration, Neurosense keeps full rights to PrimeC in ‘key territories’
PrimeC is an extended-release oral tablet that contains a fixed dose of two medications: the antibiotic ciprofloxacin and the anti-inflammatory drug celecoxib. Both drugs are individually approved by the U.S. Food and Drug Administration (FDA) for other uses — ciprofloxacin for treating bacterial infections and celecoxib as a nonsteroidal anti-inflammatory medication.
The combination in PrimeC is thought to modify several biological processes that are dysregulated in ALS patients, including nerve cell degeneration, inflammation, RNA processing, and iron accumulation.
Results from a Phase 2b clinical trial called PARADIGM (NCT05357950) and its extension have shown that PrimeC can significantly slow disease progression and improve survival outcomes in people with ALS. In particular, patients who started on the therapy in the main study had a 33% reduction in disease progression and a 58% higher survival rate after 18 months compared with those who were first given a placebo and then started on PrimeC six months later.
Data showed the therapy also slowed respiratory decline and reduced the risk of complications such as respiratory failure or hospitalization.
In December, Neurosense met with the FDA to finalize its protocol for a Phase 3 clinical trial testing PrimeC. The company plans to submit the protocol for FDA approval in the first half of this year, with the trial itself expected to start recruiting about 300 patients in mid-2025.
The plan is to randomly assign two patients to receive PrimeC for every one patient who receives a placebo. After 12 months, patients will have the option to enter a yearlong open-label extension in which all will receive PrimeC.
The binding term sheet sets out the basic terms and conditions of the unnamed pharmaceutical company’s investment in Neurosense. It constitutes a commitment by both companies to negotiate with one another in good faith and enter into a definitive agreement in the future. Binding terms sheets can also be the first documented evidence of a possible acquisition.
Under the term sheet, the pharmaceutical company will acquire the exclusive rights to distribute, market, promote, sell, and develop PrimeC for ALS in certain key markets. It will also have nonexclusive rights for research and manufacturing for PrimeC for ALS, subject to the terms and conditions of the definitive agreement.
Neurosense intends to retain full rights to PrimeC in other key territories.
As of now, the company is seeking early marketing approval in Canada based on findings from the PARADIGM trial. If the Canadian regulatory agency grants approval, the upcoming Phase 3 trial could be used to potentially gain full approval for PrimeC in the country.
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