Ceria Therapeutics Inc

A Novel Anti-inflammatoryand Anti-oxidant Therapy for Treating Non-healing Diabetic Foot Ulcers - Summary Delayed or Impaired Wound Healing Is a Serious Complication of Diabetes, Often Leading to Lower Limb Amputations. by 2050, 1 in 3 Americans Will Develop Diabetes, and Up to 34% of Diabetic Patients Will Develop a Diabetic Foot Ulcer (DFU) in Their Lifetime. Current Treatments for Dfus Include Debridement, Infection Control, Maintaining a Moist Wound Environment, and Pressure Offloading. Despite These Interventions, a Large Number of Dfus Fail to Heal and Are Associated With a Cost That Exceeds $31 Billion Annually. Chronic Inflammation and Increased Oxidative Stress Have Been Implicated in the Pathogenesis of the Diabetic Wound Healing Impairment. We Have Designed and Tested a New Therapeutic That Synergistically Targets Both Inflammation and Oxidative Stress Using Novel Cerium Oxide Nanoparticles (CNP), Which Possess Reactive Oxygen Species (ROS) Scavenging Properties, Conjugated With an Anti-inflammatory Microrna Mimic (MIR146A) That Is Deficient in Diabetic Wounds and Inhibits the Activation of Nfκb-induced Pro-inflammatory Response. Importantly, Our Novel Patented Conjugate CNP-MIR146A Efficiently Delivers MIR146A Into the Wound to Reduce Inflammation and Ros, and Accelerate Wound Healing. We Have Developed a CNP-MIR146A Specifically Formulated for Intradermal Injection (CTX-001) for the Treatment of Dfus. Our Preliminary Studies Demonstrate That a One-time Intradermal Administration of CTX-001 to Full-thickness Wounds Fully Corrects the Wound Healing Impairment in Diabetic Mice and Elicits a Significant 25% Improvement in Wounds in Diabetic Pigs, Essentially by Normalization of Inflammation and Oxidative Stress. Repeated Weekly Administration Can Correct the Diabetic Wound Healing Impairment, Similar to Healing in Non- Diabetic Wounds. Following a Pre-ind Meeting With the Fda and Having Completed a Pilot Bulk Drug Substance CGMP Manufacturing of CTX-001, the Objective of This Direct to Phase Ii Application by Ceria Therapeutics (CERIA) Is to Complete Cgmp-grade Manufacturing and Analysis of CTX-001 Drug Product (specific Aim 1) to Fulfill Ind-enabling Studies. Specific Aim 2 Will Confirm the Preclinical Efficacy of CTX-001 in Diabetic (DB/DB) Mice and a Porcine Model of Diabetic Wound Healing; We Will Assess the Role of Infection on the Efficacy of CTX-001 in Mice, and Optimize the Dose and Frequency of Administration of CTX-001 to Enhance Efficacy in the Correction of the Impaired Healing in Diabetic Pigs. in Specific Aim 3, We Will Carry Out a Dose-range Finding Acute Toxicity Study of CTX-001 in Both Rats and Minipigs, Followed by Ind-enabling Repeat Dose Toxicology Studies. in Vitro Genotoxicity Studies and an Irritation/sensitization Study in Guinea Pigs Will Complete Safety Studies in Preparation for First-in-human Clinical Trials With Our Lead Product.