TBI is an urgent and prominent public health challenge, impacting millions each year as a result of head trauma from accidents, falls, sports-related incidents, and military combat. TBI disrupts the normal functioning of the brain, leading to a range of cognitive, physical, and emotional symptoms. The collaboration agreement provides Owl Therapeutics with a global license to develop, manufacture, and commercialize NeuroSTAT^®.

"Abliva stands out as an exceptional partner for Owl Therapeutics, and we are excited to join forces in our collective commitment to advance NeuroSTAT^® (OWL-1410)," said William E. Haskins, PhD, Co-Founder of Owl Therapeutics and Chief Executive Officer of Gryphon Bio. "We are thrilled to focus our team's scientific, clinical, and business experience on this potentially game-changing treatment for military and civilian TBI patients."

Under the terms of the agreement, Abliva will contribute to both the operational and strategic elements of the program through the established steering committee. Owl Therapeutics will lead the clinical development and commercialization of NeuroSTAT^®. Upon commercialization, Abliva is eligible for royalties.

"Through this important collaboration with Abliva, Owl Therapeutics gains access to an innovative asset for TBI with orphan drug designation (ODD) in Europe and the U.S., as well as an investigational new drug (IND) approval granted Fast Track designation for clinical development and review in the U.S.," said Franklin Okumu, PhD, and Chief Technology Officer of Owl Therapeutics. "We are also excited by the potential to collaborate with clinical investigators to rapidly advance this treatment to patients in need."

"NeuroSTAT^® has demonstrated promising attributes in advanced experimental TBI models that replicate human disease," said Todd Kilbaugh, a prominent TBI researcher, advisor to Owl Therapeutics. "The scientific community is enthusiastic about collaborating closely with companies like Owl to fully unleash the potential of TBI treatments and accelerate their translation into clinical practice, ultimately enhancing the well-being of patients."

"NeuroSTAT^® has shown a promising reduction in levels of blood biomarkers of neuronal injury in advanced experimental TBI models and clinical studies," said Kevin KW Wang, PhD, an internationally renowned TBI biomarker pioneer, Co-Founder of Gryphon Bio, and Co-Founder and Chair of the Scientific Advisory Board of Owl Therapeutics. "We see this agreement as a strong endorsement of the TBI expertise that the Owl team brings to this collaboration, and we look forward to demonstrating the clinical profile of this drug with the underserved TBI patient population."

TBI places considerable strain on health care systems and society at large, incurring substantial expenses for emergency care, hospitalization, rehabilitation, and long-term care. Notably, TBI continues to be a contributing factor in one-third of injury-related fatalities in the U.S., imposing emotional and financial hardships on both patients and their families. To address this complex and pervasive health issue, it is imperative to prioritize ongoing research aimed at prevention, diagnosis, and treatment.