23 GHP Healthcare and Pharmaceutical Awards 2025 Unfortunately, despite decades of recognising the devastating consequences of mTBI, there have been no new drugs developed and submitted to the FDA for review. Consequently, there are no validated endpoints available for drug developers to utilise in the design of pivotal clinical trials targeting drug approval. Oxeia Biopharmaceuticals intends to change that. Another significant challenge that lies ahead is funding; traditional sources shy away from funding small clinical-stage biotech companies unless they are focusing on areas such as oncology, AI, and gene and cell therapies. Even with the promising results of the Phase 2a pilot study, it is virtually impossible for companies such as Oxeia Biopharmaceuticals to fund a full-scale, multisite, randomised and placebo-controlled Phase 2 clinical trial. In response to the lack of traditional investor interest, the company has engaged StartEngine, a leader in the crowdfunding sphere. The unique aspect of crowdfunding is that it is not limited to wealthy investors; any individual can invest in an area that is important to them. There are countless concussion sufferers around the world who, along with their loved ones, wish to speed up the pace of brain injury research to develop an effective therapy that treats both symptoms and underlying damage. These individuals want the chance to invest in something that can be truly beneficial to the often-debilitating post-concussion symptoms, and Oxeia plans to provide them with that chance. As Oxeia Biopharmaceuticals looks to the future, CEO and Director Dr. Michael Wyand shared: “OXE103’s pilot Phase 2a trial showed strong potential as an effective treatment for concussion. We are highly encouraged and optimistic about our next Phase 2b trial. Postconcussion patients have been not only long suffering, but also an overlooked population. Our crowdfunding campaign brings a possible solution to them, and perhaps to other neurodegenerative diseases.” Further information on Oxeia Biopharmaceuticals’ ongoing research and development efforts can be found on the company’s website. Contact: Dr. Michael Wyand Email: [email protected] Telephone: 617 302-6195 Company: Oxeia Biopharmaceuticals, Inc. Web Address: www.oxeiabiopharma.com Based in Boston, Oxeia Biopharmaceuticals is a clinical stage biotech company developing drug treatments for mild traumatic brain injury, also known as concussion, and underlying neurometabolic dysfunction. The company is comprised of passionate scientists, biotech leaders, and athletes bringing together decades of medical, scientific, and business experience to deliver a safe and effective concussion therapy to market. Oxeia Biopharmaceuticals is among a limited number of biopharma companies operating within the field of concussion research. The company has targeted the common molecular pathology found in both concussions and neurodegenerative conditions that include acute-mitochondrial dysfunction, which leads to a prolonged energy crisis in the brain that increases the risk of neuronal damage. Ghrelin is a hormone primarily produced by enteroendocrine cells of the gastrointestinal tract and is often dubbed the “hunger hormone”. Studies have shown that animals with a brain injury or neurodegenerative disease that were treated with ghrelin have improved psychomotor function and cognition. Oxeia Biopharmaceuticals is developing OXE103, a synthetic form of human ghrelin designed to treat mild traumatic brain injury. Freely crossing the blood-brain-barrier, OXE103 uniquely targets the hippocampus region of the brain, an important area for cognition and memory. Treatment with OXE103 has been shown in numerous preclinical studies to restore normal energy metabolism, increased appetite, and reduce the toxic effects of reactive oxygen species that form in low energy states. The drug is now being tested in humans to potentially treat concussions by addressing underlying neurometabolic dysfunction and axonal injury. OXE103 is a first-in-class investigational drug, with there being currently few studies and no effective pharmacological FDAapproved treatments for concussions. The drug successfully completed a pilot Phase 2a clinical trial in 2022, with positive results that showed robust treatment effect across study endpoints. The OXE103 responder rate was 85% in comparison to a baseline of 33%, showing strong potential as an effective treatment for concussion. Looking ahead, Oxeia Biopharmaceuticals will be conducting a Phase 2b randomised controlled study for OXE103, utilising 160 patients. Before this study can begin, however, the company must complete one critical step: validating the endpoint. This is one of the most important parts of a clinical trial intended to obtain FDA approval of a new drug therapy, as this enables researchers to measure the drug’s treatment effect. Approximately 69 million people experience Traumatic Brain Injury annually, with concussions accounting for about 85% of all TBI cases. Once dismissed as minor injuries, concussions are now recognised as serious neurological events with long-term consequences,fromchronicheadachesanddepressiontocognitivedeclineandincreased risk of neurogenerative disease such as Alzheimer’s and CTE. Below, we explored the remarkable research being conducted by Oxeia Biopharmaceuticals, a pioneering company at the forefront of developing targeted therapies for mild traumatic brain injury. Most Innovative mTBI Biopharma Company 2025
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