NLS Pharmaceutics to Begin Phase 3 Clinical Program for Narcolepsy Treatment

Global development-stage biopharmaceutical company, NLS Pharmaceutics Ltd. (Nasdaq:NLSP), has announced that the FDA has reviewed the full protocol for its NLS-1031 clinical study.

The company’s AMAZE clinical program for Mazindol ER will encompass two double-blind Phase 3 studies investigating Mazindol ER versus placebo in adult patients with narcolepsy commencing this summer at multiple sites in the United States.

Highlights

NLS also received approval from the independent Institutional Review Board (IRB) for its Phase 3 clinical trial protocol.

The company’s Phase 3 trials will both measure the weekly cataplexy episodes as the primary endpoint over eight weeks of treatment and excessive daytime sleepiness as a secondary objective using the Patient-Reported Outcomes Measurement Information System (PROMIS-SRI) and the Epworth Sleepiness Scale (ESS).

NLS previously reported that Mazindol ER met all primary and secondary endpoints in a Phase 2 study. Patients who rolled over into an open label extension (OLE) study showed continued improvement.

Patients treated with placebo in the randomized Phase 2 trial who subsequently received Mazindol ER in the OLE study showed similar efficacy to the Mazindol ER-treated patients in the randomized trial.

About NLS Pharmaceutics

NLS Pharmaceutics Ltd. (Nasdaq:NLSP) is a global development-stage biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, who have unmet medical needs. Headquartered in Switzerland and founded in 2015, NLS is led by an experienced management team with a track record of developing and commercializing product candidates. For more information, please visit www.nlspharma.com.