Mazindol shows promise in fentanyl addiction treatment study

ZURICH - NLS Pharmaceutics Ltd. (NASDAQ: NLSP), a biopharmaceutical company specializing in central nervous system disorders, reported positive outcomes from a preclinical study on the efficacy of Mazindol for fentanyl use disorder. The study, conducted by Key-Obs SAS, suggests that Mazindol could serve as a non-opioid therapeutic option, potentially impacting the growing market for addiction treatments.

The urgency for such treatments is underscored by the ongoing fentanyl crisis in the United States, where opioid-related overdoses, predominantly from fentanyl, are a leading cause of death among 18 to 45-year-olds. With the substance use disorder treatment market projected to grow significantly by 2029, innovations like Mazindol offer hope for safer alternatives to conventional opioid-based therapies.

Study KO-943 employed a conditioned place preference model in mice to assess the rewarding effects of fentanyl and Mazindol’s ability to alter this response. The results showed that Mazindol at a higher dose significantly reduced the fentanyl-induced preference, suggesting a dose-dependent effect and pointing to its potential in mitigating opioid rewards.

Dr. Eric Konofal, Chief Scientific Officer of NLS Pharmaceutics, highlighted Mazindol’s multi-target mechanism, which includes partial mu-opioid receptor agonism and modulation of serotonin and orexin receptors. This pharmacological action is thought to reduce opioid rewards and withdrawal symptoms without the dependence risks associated with current substitution therapies.

The announcement follows NLS Pharmaceutics’ recent financial developments, including a $3 million raise and a $25 million committed equity facility agreement, in preparation for a strategic merger with Kadimastem Ltd. The merger aims to further develop NLS’s CNS disorder treatments and Kadimastem’s cell therapy clinical assets. Kadimastem, currently valued at approximately $28.4 million in market capitalization, has shown remarkable market performance with a 422% return over the past year. According to InvestingPro, the company maintains a GOOD overall financial health score despite operating with moderate debt levels.

Mazindol’s multi-mechanism profile positions it as a differentiated asset in the addiction therapeutics landscape. Alex Zwyer, CEO of NLS Pharmaceutics, expressed the company’s commitment to addressing substance use disorders, emphasizing the significance of these preclinical findings for strategic expansion in this field. Based on InvestingPro analysis, Kadimastem appears currently overvalued, though subscribers can access 8 additional ProTips and detailed financial metrics to better understand the investment potential in this emerging therapeutic space.

The information in this article is based on a press release statement from NLS Pharmaceutics Ltd.

In other recent news, NLS Pharmaceutics Ltd. and Kadimastem Ltd. have announced a definitive merger agreement, aiming to create a Nasdaq-traded entity focused on therapies for central nervous system disorders and diabetes. The merger, which has received unanimous board approval and awaits further regulatory and shareholder endorsements, is expected to close in the second quarter of 2025. The combined company, to be named NucelX Ltd., plans to initiate a Phase IIa clinical trial for AstroRx®, a candidate for treating Amyotrophic Lateral Sclerosis (ALS). Additionally, Kadimastem has completed a pre-Investigational New Drug meeting with the FDA for its iTOL-102 therapy, a potential treatment for Type 1 Diabetes. The companies are also developing DOXA, a multi-target therapy aimed at addressing systemic complications of diabetes. This merger positions NLS and Kadimastem as leaders in diabetes innovation, leveraging their combined research strengths. The merger is set to bring together NLS’s expertise in central nervous system disorders with Kadimastem’s cell therapy platforms, including AstroRx® and IsletRx for diabetes. Shareholders of Kadimastem have already approved the merger, with NLS planning its own shareholder meeting to ratify the merger.

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