Biotech Oxeia Biopharmaceuticals is advancing a potential first FDA-approved concussion treatment into Phase IIb clinical testing. 

OXE103, a therapy for persistent concussion symptoms, demonstrated an 85% responder rate in Phase IIa clinical testing and will be evaluated in Phase IIb trial. 

Between 1.4 and 4.2 million people develop persistent concussion symptoms each year in the US. These patients experience headaches that last for months, cognitive impairment that makes work and school difficult, and lasting symptoms that stretch far beyond normal recovery timelines.  

Standard imaging often detects no structural damage from concussion, with no therapy administered by doctors to address underlying metabolic dysfunction driving persistent symptoms. 

Alex Smith, who suffered a career-altering concussion in 2012 playing quarterback for the San Francisco 49ers, said he watched teammates “deal with symptoms for months with no treatment options.” 

Smith, now an ESPN analyst, joined Oxeia’s board as an investor after reviewing the Phase IIa data. “This is the first time I’ve seen real clinical evidence that a treatment could help patients recover.” 

The Phase IIa clinical trial at University of Kansas Medical Center showed an 85% responder rate among patients treated with OXE103, compared to 33% of patients receiving standard care alone. Treated patients demonstrated reduction in symptom severity and improvement in quality of life, representing what the company believes is the first clinically meaningful improvement shown in persistent concussion patients. 

“We’re funding the Phase IIb 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.” 

Oxeia has launched an equity crowdfunding campaign to fund the Phase IIb development. The company aims to enrol 160 patients at major academic medical centres beginning in 2026.  

 

Bruno Quinney, Content Team, DDW