Neurolixis
Neurolixis is a biopharmaceutical company focused on novel drugs for the treatment of human central nervous system diseases.
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Industry | Biopharmaceuticals |
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Founded | 2011 |
Headquarters | United States ![]() |
Key people | Mark A. Varney, Adrian Newman-Tancredi |
Neurolixis Inc. was founded in 2011 by Mark A. Varney, PhD, and Adrian Newman-Tancredi, PhD, DSc. (Chief Executive Officer [1]). The company's therapeutic focus is on CNS disorders including Parkinson's disease, neurological orphan disorders, depression and cognitive deficits.[2] The company has offices in USA and in France.[3]
In September 2013, Neurolixis in-licensed two clinical-phase drugs from Pierre Fabre Laboratories, a French pharmaceutical company. The drugs (befiradol and F-15599) are targeted to the treatment of dyskinesia in Parkinson's disease and to breathing deficits in Rett syndrome, respectively.[4] In addition, Neurolixis is developing its own novel chemical entities (NCEs).
Neurolixis has been awarded a series of research grants by the Michael J. Fox Foundation and by Parkinson's UK. Neurolixis undertook research examining the effects of novel, highly selective and efficacious serotonergic drugs targeting 5-HT1A receptors in brain regions relevant to therapeutic properties in Parkinson's disease.[5] The Michael J. Fox Foundation subsequently announced that it was supporting proof-of-principle studies on befiradol (also known as NLX-112) in models of Parkinson's disease[6] and showcased Neurolixis in its Partnering Program.[7] In January 2018, the British charity Parkinson's UK announced that it had awarded Neurolixis a grant to advance development of befiradol up to clinical phase in Parkinson's disease patients.[8] In March 2019, Neurolixis announced that the US Food and Drug Administration (FDA) gave a positive response to Neurolixis' Investigational New Drug (IND) application for befiradol to be tested in a Phase 2 clinical study in Parkinson's disease patients with troublesome Levodopa-induced dyskinesia.[9] Studies published in 2020 using non-human primate models of Parkinson's disease, (MPTP-treated marmosets and MPTP-treated macaques), found that befiradol potently reduced Levodopa-induced dyskinesia at oral doses as low as 0.1 to 0.4 mg/kg. [10] [11] On 22 November 2020, The Sunday Times reported that the two charities, Parkinson's UK and Michael J. Fox Foundation, were jointly investing $2 million to support a clinical trial on befiradol in Parkinson's disease patients with troublesome Levodopa-induced dyskinesia, a potentially "life changing" drug.[12] On 23 November 2020, Parkinson's UK and Michael J. Fox Foundation, confirmed their funding in an official announcement.[13]
F-15599 (also known as NLX-101) was awarded Orphan Drug Status by the United States Food and Drug Administration (FDA) in October 2013[14] and Orphan Medicinal Product designation by the European Medicines Agency in March 2014.[15] In collaboration with researchers at the University of Bristol, Neurolixis has been awarded a grant by the International Rett Syndrome Foundation to study F-15599 in animal models of Rett syndrome.[16] In June 2015, Neurolixis was awarded a grant by the Rett Syndrome Research Trust to advance F-15599 to clinical development.[17] Subsequent studies on F-15599 investigated its functional selectivity (also referred to as 'biased agonism') at cortical serotonin 5-HT1A receptors using brain imaging techniques in rat: functional magnetic resonance imaging[18][19] and positron emission tomography.[20] The functional selectivity of F-15599 was considered to underlie its rapid-acting antidepressant-like activity in the 'chronic mild stress' (CMS) model of depression. F-15599 reversed CMS-induced anhedonia (measured as a deficit in sucrose solution consumption) after a single day of treatment.[21]
In addition to developing befiradol and F-15599, Neurolixis is also developing its own novel chemical entities (NCEs) in collaboration with a team at Jagiellonian University in Krakow, Poland. Scientists from Neurolixis and Jagiellonian University filed a patent application on the NCEs in 2016,[22] and it issued in the USA under patent number US10562853B2.[23] The NCEs are selective serotonin 5-HT1A receptor agonists that show functional selectivity for either extracellular signal-regulated kinases activation [24] or for beta arrestin activation.[25] It has been suggested that such compounds may have utility for treatment of distinct CNS disorders.[26]
References
- https://www.linkedin.com/in/adriannewmantancredi/
- "neurolixis.com". neurolixis.com. Archived from the original on 2014-05-17. Retrieved 2014-05-17.
- "Archived copy". Archived from the original on 2015-06-26. Retrieved 2015-06-25.CS1 maint: archived copy as title (link)
- "NEUROLIXIS ANNOUNCES IN-LICENSING OF TWO CLINICAL COMPOUNDS FROM PIERRE FABRE MEDICAMENT" (PDF). neurolixis.com. September 23, 2013. Retrieved 2019-06-05.
- "Parkinson's Disease Grants funded by the Michael J. Fox Foundation | The Michael J. Fox Foundation". Michaeljfox.org. 2012-10-26. Retrieved 2014-05-17.
- "Predicting the Efficacious Dose of the Selective 5-HT1A Agonist NLX-112". The Michael J. Fox Foundation for Parkinson's Research - Parkinson's Disease.
- "Archived copy". Archived from the original on 2015-06-26. Retrieved 2015-06-25.CS1 maint: archived copy as title (link)
- "Investing in a new treatment for dyskinesia - Parkinson's UK". www.parkinsons.org.uk.
- Inc, Neurolixis. "FDA Approves Neurolixis IND Application for a Clinical Trial with NLX-112 in Parkinson's Disease". PRLog.
- https://pubmed.ncbi.nlm.nih.gov/32846366/
- https://pubmed.ncbi.nlm.nih.gov/32057799/
- https://www.thetimes.co.uk/article/life-changing-drug-to-calm-parkinsons-twitches-set-for-human-trials-pj6xqxfg7
- https://www.prnewswire.com/news-releases/global-charities-join-forces-to-drive-forward-new-drug-for-parkinsons-301178988.html
- "Search Orphan Drug Designations and Approvals". Accessdata.fda.gov. 2013-10-25. Retrieved 2014-05-17.
- "Community register of orphan medicinal products". Ec.europa.eu. Retrieved 2014-05-17.
- Bristol, University of. "April: Rett syndrome research - News - University of Bristol". www.bristol.ac.uk.
- "RSRT Awards $530,000 to Neurolixis for Clinical Development of NLX-101". 24 June 2015.
- https://pubmed.ncbi.nlm.nih.gov/30030540/
- https://pubmed.ncbi.nlm.nih.gov/27211078/
- https://pubmed.ncbi.nlm.nih.gov/30576601/
- https://pubmed.ncbi.nlm.nih.gov/31290370/
- https://patents.google.com/patent/WO2017220799A1/en?oq=WO2017220799A1
- https://patents.google.com/patent/US10562853B2/en?oq=US10562853B2+
- https://pubmed.ncbi.nlm.nih.gov/30721053/
- https://pubmed.ncbi.nlm.nih.gov/32883072/
- https://pubmed.ncbi.nlm.nih.gov/31544717/