Swiss clinical-stage biopharmaceutical company NLS Pharmaceutics Ltd has entered into an exclusive option agreement with Aexon Labs Inc, a privately held US company, to develop and commercialize Aexon Labs’ dual orexin receptor agonists platform.

The option agreement grants NLS the exclusive option to in-license all of Aexon Labs’ assets for the potential treatment of narcolepsy and other neurodegenerative disorders and all future indications, as well as accesses global rights to multiple highly selective orexin-1/orexin-2 receptor agonists.

This agreement represents a potentially leading next-generation, first-in-class, oral, dual orexin receptor agonist, AEX-2, that is expected to address high unmet medical needs and has shown promising results in pre-clinical in vitro assays, according to a release from NLS. Aexon Labs has plans to initiate clinical development, including phase 1 first-in-human and phase 1b proof-of-concept studies, as early as 2024.

Zwyer says in a release, “I believe the potential acquisition of this novel and unique platform, which consists of over 300 compounds, bridges the present to the future treatment of sleep disorders as well as other neurodegenerative disorders,” says Alexander Zwyer, MBA, chief executive officer of NLS, in a release. “These new compounds, in addition to our current pipeline, including Mazindol ER for the treatment of narcolepsy, along with NLS-4 focused on idiopathic hypersomnia, long-COVID and chronic fatigue syndrome, and NLS-11, addressing Kleine-Levin Syndrome and neurodegenerative diseases will further complement and strengthen our hypersomnia franchise.”

NLS will pay Aexon Labs an upfront payment of $30,000 for the option exclusivity and $170,000 upon execution of the definitive agreement to exercise the option. In addition, Aexon Labs will receive 15% of all proceeds earned by NLS in any future sub-licensing agreements. 

Eric Konofal, MD, PhD, who works under a part-time consulting agreement for NLS Pharmaceuticals as its chief scientific officer, is the president and founder of Aexon Labs and owns 59% of Aexon Labs. Zwyer owns 35% of Aexon Labs. Zwyer holds no board or executive position at Aexon Labs.

Orexin receptor pathways play vital regulatory roles in many physiological processes and studies have shown that orexin receptor pathways are involved in pathological processes of neurological diseases such as narcolepsy, depression, ischemic stroke, drug addiction, and Alzheimer’s disease.

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