Oxeia's Concussion Drug Shows 85% Success, Offers First Hope for Millions

BOSTON, MA – January 07, 2026 – In a move that could signal a turning point for millions suffering from the debilitating aftermath of concussions, Oxeia Biopharmaceuticals has launched an ambitious effort to fund the final stages of clinical testing for what may become the first-ever FDA-approved treatment for persistent concussion symptoms. The company's drug candidate, OXE103, has already demonstrated a remarkable 85% responder rate in an early-stage clinical trial, attracting both high-profile support and public investment through a newly launched equity crowdfunding campaign.

For years, the standard medical advice for a concussion has been rest and a gradual return to activity—a frustratingly passive approach for a condition that can leave individuals with chronic headaches, cognitive fog, and emotional distress for months or even years. Oxeia is aiming to shatter that paradigm. The Boston-based biotech is now raising capital on the StartEngine platform to advance OXE103 into a large-scale Phase 2b trial, a critical step toward regulatory approval.

A Critical Unmet Need

Each year, an estimated 1.4 to 4.2 million Americans develop persistent concussion symptoms, a condition where the typical recovery period stretches into a prolonged battle against an invisible injury. While standard brain imaging like MRIs and CT scans often show no structural damage, patients are left grappling with very real and life-altering symptoms. These can include unrelenting headaches, difficulty concentrating, memory problems, vision and balance issues, and severe mood swings, making it difficult to work, attend school, or maintain personal relationships.

The U.S. Centers for Disease Control and Prevention (CDC) estimates that nearly three million concussion cases are seen in emergency rooms annually, but many more go unreported. For the significant portion of patients whose symptoms do not resolve within a few weeks—some studies suggest this figure could be as high as 30-60%—the medical system has little to offer. This lack of effective treatment stems from the complex nature of the injury, which is not structural but metabolic. A concussion triggers a neuro-metabolic cascade, creating an energy crisis in the brain that can disrupt function long after the initial impact.

"I watched teammates deal with symptoms for months with no treatment options," said Alex Smith, the former NFL quarterback who suffered a career-altering concussion in 2012. Smith, who has since joined Oxeia’s board as an investor, highlighted the desperation within the patient community. "This is the first time I've seen real clinical evidence that a treatment could help patients recover."

A New Mechanism for Healing

Oxeia's OXE103 is not another painkiller or anti-inflammatory; it targets the underlying metabolic dysfunction. The drug is a synthetic form of human ghrelin, a naturally occurring hormone known for its ability to cross the blood-brain barrier. Preclinical research suggests ghrelin plays a crucial role in restoring normal energy metabolism within the brain, particularly in the hippocampus—a region vital for memory and cognition. By stabilizing this energy imbalance, OXE103 is believed to mitigate the downstream effects of the injury, including axonal damage and inflammation.

The promise of this approach was borne out in a Phase 2a proof-of-concept trial conducted at the University of Kansas Medical Center. The study, led by Dr. Michael Rippee, enrolled 21 highly symptomatic patients within 28 days of their concussion. Of the 13 patients who opted to receive OXE103—self-injected twice daily for 14 days—an astounding 85% were classified as responders, showing clinically significant reductions in symptom severity and improvements in quality of life. This stood in stark contrast to the 33% responder rate observed in the group receiving standard care alone. The compelling data were first presented at the American Congress of Rehabilitation Medicine's annual conference and later published in the peer-reviewed journal Neurotrauma Reports.

"We're funding the Phase 2b trial that could establish the first approved concussion treatment," said Michael Wyand, CEO of Oxeia Biopharmaceuticals. "We're validating the endpoints that create the regulatory pathway for the entire industry. For the first time, there's a real path to bringing treatment to millions of patients who have no options."

An Unconventional Path to Market

Oxeia's journey has been significantly streamlined by a savvy business strategy. In 2017, the company secured a licensing agreement with pharmaceutical giant Daiichi Sankyo for its ghrelin molecule, then known as SUN11031. This deal provided Oxeia with access to a massive trove of development data, including full preclinical safety packages and results from multiple human trials where over 300 patients were treated with ghrelin for other conditions. This access, valued at over $100 million, allowed the company to bypass an estimated five to seven years of early-stage safety testing and proceed directly to efficacy trials for concussion.

Now, to fund its pivotal next stage, Oxeia is turning to the public. The equity crowdfunding campaign on StartEngine allows retail investors to buy a stake in the private company with a minimum investment of $500, based on a $50 million valuation. The funds raised will be used to initiate the planned Phase 2b trial, a randomized, double-blind, placebo-controlled study designed to enroll 160 patients across major academic medical centers starting in 2026. This trial will use the Post Concussion Symptom Scale (PCSS) as its primary endpoint, a key step in validating the drug for the FDA.

This Reg CF offering represents a unique, albeit high-risk, opportunity for the public to invest directly in a late-stage biotech venture addressing a widespread medical problem. As with any investment in a private, clinical-stage company, there is a significant risk of loss, but the potential upside—both financially and for public health—is substantial.

The Race for a Solution

While Oxeia is a frontrunner, it is not alone in the quest to solve the concussion puzzle. The field of traumatic brain injury (TBI) therapeutics is growing, with several companies exploring different approaches. Astrocyte Pharmaceuticals is in Phase 2 with its neuroprotectant candidate, AST-004, for acute concussion. Other companies like Acorda Therapeutics and BrainStorm Cell Therapeutics have also shown promising data in trials for TBI-related conditions. However, Oxeia’s specific focus on treating the persistent symptoms of concussion with a neuro-metabolic agent places it in a unique position.

With no approved drugs on the market, the first company to successfully navigate the FDA's approval process will not only capture a significant market but also establish the clinical and regulatory framework for all subsequent treatments. For Oxeia, the upcoming Phase 2b trial represents that critical hurdle. The results of this larger, placebo-controlled study will be a pivotal moment, determining if this promising therapy can finally deliver a validated treatment to a patient population that has waited for decades.