ASX and NASDAQ listed Incannex Healthcare (ASX:IHL) (NASDAQ:IXHL) have engaged Curia to scale up the fill-finish manufacture of IHL-216A in compliance with current good manufacturing practice (cGMP).
Incannex has previously found that CBD and isoflurane acts synergistically to reduce neuronal damage, neuroinflammation and behavioural deficits that are consequences of Traumatic Brain Injury (TBI).
Sixty-nine (69) million people are estimated to incur a TBI annually(1). There are currently no registered pharmaceutical agents approved for the treatment of TBI. Current treatment strategies for TBI range from rest in minor TBI and concussion to surgical interventions to deal with hematomas in severe TBI(2).
IHL-216A is a combination drug that combines CBD with any volatile anaesthetic agent, including isoflurane. IHL-216A has been designed to be administered soon after head trauma to reduce secondary brain injuries that lead to neurological deficits.
Incannex Chief Scientific Officer Dr Mark Bleackley;
"Scaling up cGMP manufacture of IHL-216A is an exciting step in the development of our product and represents a critical milestone for delivering an inhaled drug, such as IHL-216A. Its manufacture will facilitate investigation of the product in the well-controlled clinical trials we are designing, with feedback from FDA, to assess the safety and therapeutic benefit in patients with traumatic brain injuries".
"IHL-216A has been observed to have a greater neuroprotective effect in a rodent model of sports concussion than CBD, and results indicate restoration of the spatial memory deficit post-concussion with IHL-216A administration. Given that there is no registered treatment for the secondary effects of concussion, or traumatic brain injury, we look forward to working with Curia during this exciting phase of development for IHL-216A".
"Curia is honoured to be partnering with Incannex as it addresses an area of unmet patient need,"
Chris Conway, president, R&D, Curia.
"We look forward to our scientific collaboration to help advance this potential treatment from idea to impact."
- Dewan MC, Rattani A, Gupta S, Baticulon RE, Hung Y-C, Punchak M, Agrawal A, Adeleye AO, Shrime MG, Rubiano AM. 2018. Estimating the global incidence of traumatic brain injury. J Neurosurg 130:1080–1097.
- Galgano M, Toshkezi G, Qiu X, Russell T, Chin L, Zhao L-R. 2017. Traumatic Brain Injury: Current Treatment Strategies and Future Endeavors. Cell Transplant 26:1118–1130.