Ceramedix Awarded Phase 2B NIH SBIR Grant to Evaluate the Non-Clinical Pharmacology of Its Lead Candidate to Support IND Submission

Approximate $3 Million Grant Will Fund Additional Research for Mitigating Illness Due to Radiation Exposure

NEW YORK, Aug. 24, 2023 /PRNewswire/ -- Ceramedix Holding, LLC (Ceramedix), a privately-held biotherapeutics company developing a new class of antibody-based drugs designed with the aim to address novel disease targets involving the microvasculature, today announced it was awarded a $3,007,043 Phase 2B National Institutes of Health (NIH) Small Business Innovation Research (SBIR) grant to evaluate the non-clinical pharmacology of its lead drug candidate. Specifically, the anti-ceramide antibody that disrupts cell death signaling is in development through the NIH as a potential therapeutic to mitigate and/or treat illness due to radiation exposure. The grant was issued by the National Institute of Allergy and Infectious Diseases (NIAID) at the NIH, a part of the U.S. Department of Health and Human Services.

The grant will specifically fund the establishment of independent potency assay capabilities within Ceramedix, as well as in vitro studies to better understand the pharmacology of the antibody. Additionally, the grant will fund in vivo studies that will inform dose selection and dose scheduling, which are essential for the submission of an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA).

"The award of this NIH SBIR grant reflects potential of the antibody to prevent and treat lethal gastrointestinal (GI) acute radiation syndrome (ARS)," stated Charles L. Dimmler, III, Managing Member of Ceramedix. "Successful completion of this preclinical work will accelerate the submission of an IND and the clinical evaluation of this potentially transformative therapeutic platform, which could have profound benefits in protecting civilians, defense personnel, and first responders."

About Ceramedix antibodies
Ceramedix' anti-ceramide antibodies that disrupt cell death signaling bind ceramide on the extracellular leaflet of the plasma membrane of endothelial cells in the GI tract, and in other organs. By binding ceramide, the formation of ceramide-rich platforms is disrupted, which thereby disrupts the cell death signaling pathway, and improves survival. Extensive data in multiple species, including nonhuman primates (NHPs), show that disrupting the ceramide signaling pathway protects and mitigates lethal GI-ARS, preventing lethality. To date, Ceramedix has demonstrated dose-dependent efficacy in NHPs as well as survival benefits in mice. These antibodies represent a major breakthrough for the treatment of the lethal GI-ARS, and, as such, have the potential to become the first FDA-approved and available treatment for GI-ARS. The product's subcutaneous route of administration makes it more suitable for mass casualty events than an intravenous-based treatment.

About Ceramedix Holding, LLC
Ceramedix Holding, LLC is a privately-held, preclinical stage biotherapeutics company developing a new class of pharmacologic drugs designed to address novel disease targets involving the microvasculature. Using patented intellectual property, exclusively licensed from Memorial Sloan Kettering Cancer Center (MSK), the Ceramedix technology disrupts endothelial ceramide injury signaling to enable restoration of microvascular homeostasis. The company's traditional clinical indication is the treatment of severe diseases of the microvasculature associated with diabetes, with an initial focus on vascular diseases of the eye, specifically diabetic retinopathy. Additional near-term opportunities include diabetic kidney disease and pulmonary injury, including acute respiratory distress syndrome.

Contact at Ceramedix Holding, LLC:
Lisa Janicki
Controller
212.933.4128
Lisa.janicki@ceramedix.com

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SOURCE Ceramedix Holding, LLC