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A service for healthcare industry professionals · Tuesday, March 18, 2025 · 794,954,006 Articles · 3+ Million Readers

Neurolixis Publishes Positive Phase 2A Trial Results for NLX-112 in Parkinsonโ€™s Disease

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NLX-112 Shows Groundbreaking Dual Efficacy in Reducing Levodopa-Induced Dyskinesia and Parkinsonian Motor Symptoms

NLX-112's first-in-class mechanism of action, selectively targeting the serotonin system rather than dopamine, offers a novel approach that could significantly improve the lives of patients.”
— Dr. Adrian Newman-Tancredi (CEO, Neurolixis)
PARK RIDGE, NJ, UNITED STATES, March 18, 2025 /EINPresswire.com/ -- Neurolixis, Inc., a clinical-stage biopharmaceutical company developing innovative therapies for neurologic disorders with high unmet medical needs, today announced the publication of the results from its successful Phase 2A proof-of-concept clinical trial of NLX-112 (befiradol) in Parkinsonโ€™s disease. The findings, published in the prestigious journal ๐˜”๐˜ฐ๐˜ท๐˜ฆ๐˜ฎ๐˜ฆ๐˜ฏ๐˜ต ๐˜‹๐˜ช๐˜ด๐˜ฐ๐˜ณ๐˜ฅ๐˜ฆ๐˜ณ๐˜ด, highlight NLX-112โ€™s potential as a first-in-class, non-dopaminergic therapy with dual efficacy in addressing both levodopa-induced dyskinesia (LID) and motor impairment in Parkinsonโ€™s patients.

The randomized, double-blind, placebo-controlled trial, supported by The Michael J. Fox Foundation and Parkinsonโ€™s UK, evaluated NLX-112 in patients with troubling LID. The study successfully met its primary endpoint of safety and tolerability, as well as its secondary endpoint of significantly reducing LID. Notably, NLX-112 also demonstrated anti-parkinsonian effects, significantly improving motor function in study participants. The full publication is available with Open Access:

๐—ก๐—Ÿ๐—ซ-๐Ÿญ๐Ÿญ๐Ÿฎ ๐—ฟ๐—ฎ๐—ป๐—ฑ๐—ผ๐—บ๐—ถ๐˜‡๐—ฒ๐—ฑ ๐—ฃ๐—ต๐Ÿฎ๐—” ๐˜๐—ฟ๐—ถ๐—ฎ๐—น: ๐˜€๐—ฎ๐—ณ๐—ฒ๐˜๐˜†, ๐˜๐—ผ๐—น๐—ฒ๐—ฟ๐—ฎ๐—ฏ๐—ถ๐—น๐—ถ๐˜๐˜†, ๐—ฎ๐—ป๐˜๐—ถ-๐—ฑ๐˜†๐˜€๐—ธ๐—ถ๐—ป๐—ฒ๐˜๐—ถ๐—ฐ ๐—ฎ๐—ป๐—ฑ ๐—ฎ๐—ป๐˜๐—ถ-๐—ฝ๐—ฎ๐—ฟ๐—ธ๐—ถ๐—ป๐˜€๐—ผ๐—ป๐—ถ๐—ฎ๐—ป ๐—ฒ๐—ณ๐—ณ๐—ถ๐—ฐ๐—ฎ๐—ฐ๐˜†.
๐˜”๐˜ฐ๐˜ท๐˜ฆ๐˜ฎ๐˜ฆ๐˜ฏ๐˜ต ๐˜‹๐˜ช๐˜ด๐˜ฐ๐˜ณ๐˜ฅ๐˜ฆ๐˜ณ๐˜ด, 2025 (https://doi.org/10.1002/mds.30175)

๐——๐—ฟ. ๐—”๐—ฑ๐—ฟ๐—ถ๐—ฎ๐—ป ๐—ก๐—ฒ๐˜„๐—บ๐—ฎ๐—ป-๐—ง๐—ฎ๐—ป๐—ฐ๐—ฟ๐—ฒ๐—ฑ๐—ถ, CEO of Neurolixis, commented: โ€œWe are pleased to make the detailed results of the trial publicly available. NLX-112โ€™s reduction of both dyskinesia and parkinsonism represents a potential paradigm shift in Parkinsonโ€™s treatment. Its first-in-class mechanism of action, selectively targeting the serotonin system rather than dopamine, offers a novel approach that could significantly improve the lives of patients.โ€

๐—” ๐—ก๐—ผ๐˜ƒ๐—ฒ๐—น ๐— ๐—ฒ๐—ฐ๐—ต๐—ฎ๐—ป๐—ถ๐˜€๐—บ ๐—ผ๐—ณ ๐—”๐—ฐ๐˜๐—ถ๐—ผ๐—ป
Unlike current Parkinsonโ€™s treatments that target the dopamine system, NLX-112 acts on the serotonin (5-HT) system, as a highly selective full activator of 5-HT1A receptors. This unique mechanism differentiates NLX-112 from previous serotonergic drugs and is believed to underlie its dual efficacy in reducing dyskinesia and improving motor function. The promising results from this Phase 2A trial support further development of NLX-112 as a transformative therapy for movement disorders. Neurolixis is actively planning next steps in the clinical development program to advance NLX-112 toward potential regulatory approval.

๐—”๐—ฏ๐—ผ๐˜‚๐˜ ๐—ฃ๐—ฎ๐—ฟ๐—ธ๐—ถ๐—ป๐˜€๐—ผ๐—ปโ€™๐˜€ ๐——๐—ถ๐˜€๐—ฒ๐—ฎ๐˜€๐—ฒ ๐—ฎ๐—ป๐—ฑ ๐—ฅ๐—ฒ๐—น๐—ฎ๐˜๐—ฒ๐—ฑ ๐— ๐—ผ๐˜ƒ๐—ฒ๐—บ๐—ฒ๐—ป๐˜ ๐——๐—ถ๐˜€๐—ผ๐—ฟ๐—ฑ๐—ฒ๐—ฟ๐˜€
Parkinsonโ€™s disease is the second most common neurodegenerative disorder, affecting over 10 million people worldwide. Levodopa, the mainstay treatment for Parkinsonโ€™s, often leads to debilitating dyskinesias (involuntary movements) after prolonged use. Up to 80% of patients develop LID within ten years of levodopa therapy. Current treatments for LID, such as amantadine, are limited by side effects and variable efficacy, underscoring the need for new therapeutic options.

As well as Parkinsonโ€™s disease, other disorders also involve dysfunction in the basal ganglia, a brain region critical for coordinating movement. Such disorders include spinocerebellar ataxia, Huntingtonโ€™s disease, essential tremor and dystonia, and lead symptoms such as tremors, rigidity, and impaired motor control.

๐—”๐—ฏ๐—ผ๐˜‚๐˜ ๐—ก๐—ฒ๐˜‚๐—ฟ๐—ผ๐—น๐—ถ๐˜…๐—ถ๐˜€
Neurolixis is a biopharmaceutical company dedicated to developing innovative therapies for central nervous system disorders, including Parkinsonโ€™s disease, autism spectrum disorders, pain, and depression. The companyโ€™s drug candidates are serotonin 5-HT1A receptor โ€˜biased agonistsโ€™, designed to target specific brain regions for enhanced therapeutic effects.

NLX-112 has previously shown favorable safety and tolerability in over 600 subjects across Phase 1 and Phase 2 trials for other indications. In addition to Parkinsonโ€™s disease, NLX-112 is being investigated as a potential treatment for spinocerebellar ataxia, a rare motor disorder. Neurolixisโ€™ pipeline also includes NLX-101, a Phase 1 candidate for rare autism spectrum disorders (Rett syndrome and Fragile X syndrome), and NLX-204, a preclinical candidate for pain and mood disorders.

For more information, email contact@neurolixis.com.

ADRIAN NEWMAN-TANCREDI
NEUROLIXIS
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