Oxeia is developing a first-in-class synthetic human ghrelin—an endogenous hormone that crosses the blood-brain barrier—therapy to target the hippocampus. By restoring normal energy metabolism and reducing the toxicity caused by reactive oxygen species (which form in low-energy states), it treats the neuro-metabolic dysfunction and axonal injury that concussions cause. Distress signals “The brain has a few mechanisms to heal itself, and a number of distress signals that indicate it’s in trouble,” notes William Korinek, PhD, co-founder and CEO of Astrocyte Pharmaceuticals. “One of those danger signals is adenosine.” When cells’ ATP energy levels are depleted, adenosine is released, which tells the astrocytes to go into action, utilizing alternative energy stores and clearing away more of the damaging excitatory neurotransmitters. “Our drug (AST-004) promotes that same set of intrinsic healing mechanisms.” Korinek suggests AST-004 may aid recovery as well as halt further damage, based on preclinical results in both TBI and stroke. The other hurdle in the development of widespread clinical trials for concussion is the perceived lack of clearly defined study endpoints. Currently, neurologic diseases, including migraines, Parkinson’s disease, ALS, depression, and Alzheimer’s disease as well as concussions, are based on assessment of patient symptoms, Wyand points out. “These endpoints are accepted as primary endpoints for approval of therapeutics by the FDA, and have specific guidance documents for validation,” he says. If biomarkers were required to conduct widespread clinical trials, “there would not be any drug development or approved drugs for any of these indications.” https://www.genengnews.com/topics/translational-medicine/game-on-for-concussion-therapies/
OXE-103 overview Oxeia Biopharmaceuticals (Oxeia) is a clinical stage biotechnology company that develops drug treatments for mild traumatic brain injury or concussion and underlying neuro-metabolic dysfunction. The company’s lead pipeline candidate includes OXE-103, potent mitochondrial stabilizer that crosses the blood brain barrier and activates a well-characterized pathway that promotes normal mitochondrial activity. It also provides medical solutions to aid recovery. The company conducts human clinical research for drug development. It partners with pharmaceutical and biotechnology companies. Oxeia is headquartered in San Diego, California, the US. OXE-103 (SUN11031) is under development for the treatment of traumatic brain injury (which leads to neurodegenerative conditions and concussion) and covid long hauler syndrome (“Long Covid”). The drug candidate is a ghrelin analogue which binds to growth hormone secretagogue receptor GHS-R1a (GHSR) and is administered through subcutaneous injection and through intravenous route. It was also under development for the treatment of cachexia associated with chronic obstructive pulmonary disease and in subjects with anorexia nervosa. https://www.pharmaceutical-technolo...traumatic-brain-injury-likelihood-of-approval
