Neurolixis expands rare autism disorders research program
Ohio Pen/10264209

PARK RIDGE, N.J. - OhioPen -- Neurolixis, Inc., a biopharmaceutical company that discovers and develops novel treatments to treat disorders of the brain, today announced that the United States Patent and Trademark Office (USPTO) granted a patent (US11974992B2) covering the use of NLX-101, a clinical phase drug candidate, for treatment of Fragile X syndrome (FXS). FXS is a rare genetic autism spectrum disorder which affects about 1 in 5000 individuals and is a leading cause of inherited intellectual disability. There are no approved treatments for Fragile X syndrome.

NLX-101 is a first-in-kind, selective serotonin 5-HT1A receptor 'biased agonist' which attenuates symptoms in a transgenic mouse model of FXS, suggesting that it can reduce anxiety and improve cognition in people with FXS. The patent, which is the fruit of a successful and ongoing collaboration between Neurolixis and researchers at the University of California, Riverside (UCR) and is being prosecuted by Neurolixis in other major pharmaceutical markets.

Professor Khaleel Abdulrazak, who supervised the experiments conducted by Dr. Xin Tao at UCR, commented: "People with Fragile X syndrome exhibit a range of debilitating symptoms, many of which can be modeled in transgenic mice. If the striking activity of NLX‑101 in the mice translates to the clinic, it could bring substantial benefits to patients and their carers."

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"We are excited to expand the Neurolixis' rare disease program to Fragile X syndrome. We have already shown that NLX-101 has robust activity in transgenic models of Rett syndrome and the new patent expands our presence in the orphan autism disorder indication space.  This is an important milestone as we embark on the development work required to initiate clinical studies in Fragile X syndrome patients," commented Adrian Newman-Tancredi, PhD, DSc, CEO of Neurolixis, Inc.

About NLX-101
NLX-101 acts on the brain's serotonin system and exhibits preferential activation of 5-HT_1A receptors located in specific regions of the brain: such 'biased agonism' underlies its potent beneficial effects in animal models of cognition and mood. NLX-101 is an orally administered agent that has begun Phase 1 clinical  in healthy volunteers. Neurolixis plans to investigate its ability to improve cognitive and mood dysfunction in Fragile X syndrome and other autism spectrum disorders.

About Fragile X Syndrome
Fragile X syndrome is a genetic disorder caused by a mutation in the FMR1 gene. It is the most common form of inherited intellectual disability and the leading cause of autism-like symptoms in males. Symptoms include intellectual disability, physical features, and behavioral symptoms. Genetic testing and physical examination are used for diagnosis. Supportive care and medications can help manage symptoms but there is no cure or approved treatment. The incidence of Fragile X syndrome is approximately 1 in 4,000 males and 1 in 8,000 females; in the United States 60 to 80 thousand individuals are affected.

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About Neurolixis, Inc.
Neurolixis is a privately held biotechnology company developing therapies for disorders of the nervous system. The Company is focused on developing small molecule drugs for the treatment of disorders including Parkinson's disease, autism, depression and pain. Additional information regarding Neurolixis is available at http://www.neurolixis.com.

About the University of California, Riverside
UCR is a public research university located in Riverside, California, USA. It is one of the ten campuses of the University of California system. UCR is a research-intensive institution, with a strong focus on interdisciplinary research collaborations and innovation. The university has  research expenditures of $200 million (2023) and is the only AAU and R1 institution in the Inland Empire of Southern California.

Forward Looking Statement
Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, including: our dependence on third parties for the development, regulatory approval and successful commercialization of our products, the inherent risk of failure in developing product candidates based on new technologies, risks associated with the costs of clinical development efforts, as well as other risks. Actual results may differ materially from those projected. These forward-looking statements represent our judgment as of the date of the release. Neurolixis disclaims any intent or obligation to update these forward-looking statements.