Carnyx Therapeutics 口服睡眠候选药 CNYX-005 进入 IND 申报准备阶段
Carnyx Therapeutics Advances Lead Oral Sleep Candidate CNYX-005 into IND-Enabling Development
Carnyx Therapeutics 宣布其口服睡眠候选药 CNYX-005 进入 IND 申报准备阶段，向首次人体临床研究推进。公司此前报告，在老年大鼠中 CNYX-005 较对照使总睡眠时间增加约 1.5 至 2 小时，主要来自 NREM 睡眠增加。该 IND 准备项目将表征 CNYX-005 的安全性、耐受性、毒理、药代动力学、暴露特征与剂量选择参数。
, /PRNewswire/ -- Carnyx Therapeutics Ltd. ("Carnyx" or the "Company"), a preclinical-stage biopharmaceutical company developing first-in-class molecular therapeutics for sleep (CNYX-005) and retinitis pigmentosa (CNYX-001), today announced the advancement of its lead oral sleep candidate, CNYX-005, into Investigational New Drug (IND)-enabling development.
This milestone brings CNYX-005 closer to potential first-in-human clinical studies. The Company recently reported preclinical findings showing that CNYX-005 increased total sleep time by approximately 1.5 to 2 hours compared with controls, driven primarily by increased non-rapid eye movement (NREM) sleep, in aged rats.
"The increase in NREM sleep we observed in our preclinical research is encouraging as we further investigate CNYX-005's potential to improve not just sleep duration, but sleep architecture and ultimately, quality," said Dr. Chris Brearley, Chief Medical Officer of Carnyx. "While treatments for sleep disorders are available, limitations related to safety, tolerability and long-term use highlight the need for additional therapeutic options."
Research shows that as people age, they often have more difficulty falling and staying asleep, along with changes in sleep physiology that include a loss of deep NREM sleep. NREM sleep plays an important role in memory consolidation, and researchers are investigating its role in clearing metabolic waste from the brain. The global sleep-disorder treatment drugs market is projected to double in value from 2025 to 2032, reaching US$44.08 billion, according to IndustryARC.
CNYX-005 originated from research involving Epitalon, a peptide that has attracted interest in longevity and biohacking circles for its proposed effects on aging and sleep. However, the U.S. Food and Drug Administration (FDA)has noted that compounded Epitalon lacks sufficient human safety data.
"There's a fundamental difference between a compound generating hype in consumer wellness communities and a distinct therapeutic candidate like CNYX-005, which is undergoing the formal drug development process," said Prof. Patrick Gunning, Chief Executive Officer of Carnyx. "This process is designed to establish how a candidate behaves in the body, inform safe dose selection, and generate the evidence needed to evaluate its potential benefits in clinical studies."
The IND-enabling program aims to characterize CNYX-005's safety, tolerability, toxicology, pharmacokinetics, exposure profile, and dose selection parameters to support an IND submission and first-in-human clinical studies.
About Carnyx Therapeutics Ltd.
Carnyx Therapeutics Ltd. is a preclinical-stage biopharmaceutical company developing first-in-class molecular therapeutics for sleep and retinitis pigmentosa. The Company is building a proprietary pipeline of novel product candidates designed to address unmet medical needs by translating emerging biology into rigorously developed therapeutics. Its lead sleep program, CNYX-005, is an orally administered candidate currently undergoing IND-enabling development.
Learn more:https://www.carnyxtx.com/
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Carnyx Therapeutics' expectations, plans, outlook, prospects, and product and service offerings, including CNYX-005 and other new product launches and potential clinical developments. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially. These factors should not be construed as exhaustive. Forward-looking statements speak only as of the date they are made, and Carnyx Therapeutics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Readers of this press release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this press release.
SOURCE Carnyx Therapeutics, LTD
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