INDIANAPOLIS — Preclinical-stage biopharmaceutical developer Carnyx Therapeutics Ltd. has officially unveiled its lead oral sleep candidate, CNYX-005. The announcement, made on Oct. 23, 2026, is accompanied by promising preclinical data demonstrating a substantial increase in total sleep time and non-rapid eye movement (NREM) sleep in aged animal models. Alongside these scientific developments, the company has strengthened its executive leadership team by appointing Chris Brearley, M.D., as Chief Medical Officer to guide the candidate through its upcoming clinical development phases.

Preclinical Findings: Restoring Sleep Architecture

In preclinical evaluations, aged rats administered with CNYX-005 exhibited an increase of approximately 1.5- to 2-hour in total sleep time compared to the control arm of the study. This extension in sleep duration was primarily driven by an increase in NREM sleep. To capture these changes with high precision, researchers utilized continuous electroencephalography (EEG) monitoring to measure the sleep architecture of the subjects.

According to Carnyx CEO Prof. Patrick Gunning, the therapeutic goal extends beyond merely sedating subjects. “Our objective is not simply to induce sleep, but to investigate whether we can support restorative sleep physiology,” Gunning stated. He emphasized that the observed increase in NREM sleep is particularly significant because it suggests CNYX-005 may actively influence sleep architecture, rather than simply increasing the raw time spent asleep.

The Role of NREM Sleep in Healthy Aging

NREM sleep represents a fundamental component of normal sleep architecture. Its deeper stages are closely linked to critical restorative physiological processes, including growth, hormone secretion, and tissue repair. As organisms age, sleep architecture naturally undergoes degenerative changes, which commonly include marked reductions in deep NREM sleep and increased sleep fragmentation. By targeting these specific age-related declines, CNYX-005 aims to address a widespread physiological challenge associated with aging.

Strategic Leadership Expansion: Welcoming Dr. Chris Brearley

To transition CNYX-005 from preclinical research into active clinical development, Carnyx has appointed veteran drug developer Chris Brearley, M.D., as its Chief Medical Officer. Dr. Brearley brings more than 30 years of experience in translational medicine, clinical pharmacology, and early-stage drug development.

His professional background includes senior roles at major pharmaceutical companies, including:

  • Pfizer
  • Amgen
  • Serono

Dr. Brearley has extensive experience designing and overseeing first-in-human and early-stage clinical studies, making him uniquely positioned to lead the clinical translation of Carnyx's sleep program. Commenting on the preclinical data, Dr. Brearley noted, "These findings provide important evidence supporting further evaluation of CNYX-005. We are particularly encouraged by the observed increase in NREM sleep as we investigate the candidate's potential role in restorative sleep." He expressed his commitment to translating these findings into a rigorous clinical development program to support CNYX-005 toward potential clinical evaluation.

Scientific Foundations and Peptide Biology

The development of CNYX-005 is rooted in extensive research into peptide biology associated with sleep regulation and healthy aging. This scientific foundation includes historical research involving Epitalon. However, Carnyx clarifies that CNYX-005 is a distinct therapeutic candidate. The company is systematically applying advanced medicinal chemistry, pharmacology, and drug-development methodologies to establish the candidate's efficacy, safety, and pharmacokinetic profiles.

Navigating the Regulatory Landscape

The announcement arrives amid heightened regulatory and public interest in peptide-based therapies. The U.S. Food and Drug Administration recently reviewed Epitalon and a selection of other peptides regarding their proposed use in compounding pharmacies.

Prof. Gunning addressed this landscape, noting, "There is growing scientific and public interest in peptides and their potential applications in health and longevity, often ahead of rigorous clinical evidence." He emphasized that Carnyx's corporate focus remains on translating promising biological insights into formally developed therapeutic candidates through systematic preclinical evaluation and, ultimately, clinical testing.

Expanding the Pipeline: Addressing Retinitis Pigmentosa

While CNYX-005 serves as the lead candidate for the company's sleep program, Carnyx is also leveraging its molecular platform to address other underserved therapeutic areas. The company is actively developing CNYX-001, an investigational candidate designed to treat retinitis pigmentosa, a rare genetic eye condition. Through these parallel tracks, Carnyx is building a proprietary pipeline of novel product candidates designed to address significant unmet medical needs by translating emerging biology into rigorously developed therapeutics.