The development work on Incannex Healthcare's inhaled drug product will be undertaken at Vectura’s Chippenham, UK facility
Vectura Group, an inhalation CDMO, has signed an agreement with Incannex Healthcare, an Australian cannabinoid medicines development company. Vectura will provide pre-clinical development services for IHL-216A, Incannex’s proprietary inhaled drug product for the treatment of traumatic brain injury (TBI).
Under the terms of the agreement, Vectura will undertake formulation screening studies, manufacturing process optimisation studies and stability assessments, as well as manufacturing a laboratory-scale batch of IHL-216A to support toxicological studies.
The candidate is a combination drug combining cannabidiol (CBD) with the anaesthetic isoflurane, which the company says it’s previously found to synergistically reduce neuronal damage, neuroinflammation and behavioural deficits resulting from TBI.
The drug has been designed to be administered soon after head trauma to reduce secondary brain injuries, as well as satisfying the World Anti-Doping Agency (WADA) and Australian Sports Anti-Doping Authority (ASADA) specifications for use by athletes at risk of TBI and chronic traumatic encephalopathy.
Incannex has partnered with the Trauma Group at Monash University’s Department of Neuroscience in Australia to do an in vivo study on the effect of the drug in sports concussion, based on a model of TBI developed in collaboration with the US National Football League (NFL). Vectura will further develop and progress the formulation in parallel with the in vivo experiments based on the NFL model, ahead of clinical trials.
Mark Bleackley, Incannex’s CSO, said: “The in vivo study we have developed offers the opportunity to accelerate this programme through to clinical development, and we look forward to working with Vectura, leveraging its wealth of experience in developing inhaled drugs, to progress this treatment to the next stage.”
Mark Bridgewater, Vectura’s CCO, said: “The risks associated with head injuries in sport are becoming more widely recognised, and this project is at the forefront of research to not only make sports safer, but reduce the morbidity and mortality rates of people suffering serious head traumas. There are currently no pharmaceutical agents approved for the treatment of TBI, and we look forward to working with Incannex to develop a truly innovative and potentially life-saving drug.”