Atelerix Life Sciences

Atelerix Life Sciences Inc. Announces BARDA Contract to Support First-in-Human Clinical Trial of ATLX-0199 as a Novel Respiratory Stimulant

New therapeutic treatment being developed to reverse respiratory depression

CHARLOTTESVILLE, VA., Sep. 27, 2023. Atelerix Life Sciences Inc., a leader in new therapeutics for unmet medical needs related to respiratory depression, announced today that it has been awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA), a component of the Administration for Strategic Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), a U.S. government agency.

The contract consists of $749,000 awarded for the continued development and clinical testing of ATLX-0199 as a novel therapeutic treatment for respiratory depression, often the cause of morbidity and mortality in hospital critical care settings. ATLX-0199 has been shown in animal models to reverse respiratory depression by a novel mechanism of action, addressing an unmet medical need for a new therapeutic modality that can restore breathing while maintaining needed sedation and pain relief. The drug, licensed to Atelerix Life Sciences, under an agreement with Case Western Reserve University, harnesses research into the role of newly identified voltage gated potassium channels in stimulating respiratory drive. The primary objectives of the contract are to successfully manufacture GMP drug product, submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), and complete a Phase 1a clinical trial establishing basic human safety parameters in 2025.

“We are privileged to have BARDA’s support,” said David Kalergis, Co-Founder and CEO at Atelerix Life Sciences. “Their strategic guidance and extensive expertise will speed our efforts in developing ATLX-0199 as a breakthrough treatment for respiratory depression.”

The award is a component of BARDA’s DRIVe’s Host Directed Therapeutics program . The project is supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00053.

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About Atelerix Life Sciences Inc.

Atelerix Life Sciences Inc. is a biotech company developing a proprietary platform technology of small molecule drugs targeting unmet medical needs. The Company’s lead compound is ATLX-0199, a novel respiratory stimulant to address morbidity and death arising from drug-induced respiratory depression (DIRD) and related conditions. The current approach to drug-induced respiratory side effects from opioid or sedative medications is to administer an opioid receptor antagonist such as naloxone, which can help reverse certain life-threatening conditions. These, however, carry risks and limitations, particularly as they suppress pain control, making them problematic in the surgical and critical care settings. Atelerix’s solution is found within the new platform of small molecule drugs called active thiol-based compounds (ATBCs) targeted at safely preventing or reversing respiratory depression via a novel molecular pathway. Lead drug ATLX-0199 uses a novel mechanism of action to reverse DIRD while preserving vital pain relief and sedation, with first uses targeted in the perioperative and critical care hospital settings.