In Australia, a cannabinoid and psychedelic compound developer has now aligned itself with a New York-based organization to expedite the production of a novel drug designed to combat the harmful effects of concussions and traumatic brain injuries (TBI).
On Tuesday, Incannex Healthcare Limited (NASDAQ: IXHL) (ASX: IHL) announced that it had entered into a partnership with Curia Global, Inc. (NASDAQ: AMRI) to help accelerate the production of IHL-216A, a proprietary inhaled drug developed by Incannex.
Incannex states that the new engagement with Curia signifies considerable progress in the production process for IHL-216A that can be linked to compelling results from proof-of-concept research that was revealed in June last year.
Those essential studies conducted by Incannex prior to the collaboration with Curia established IHL-216A as an “optimal inhaled formulation” on an investigational scale, and now, Curia has been hired to accelerate the fill-finish manufacture of the new drug in accordance with Current Good Manufacturing Practices (cGMP).
$IHL (#ASX) $IXHL (#nasdaq) #Incannex announces scale up of manufacture of neuroprotective drug IHL-216A following proof-of-concept in formulation development. Files another patent application.
(#cbd #concussion #CTE #biotech #fda)
Read here: https://t.co/EMuaFbpDGk pic.twitter.com/8jTE96J7y1
— Incannex Healthcare (@ASX_IHL) August 1, 2022
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Incannex describes IHL-216A as a combination drug that utilizes CBD in conjunction with any volatile anaesthetic agent, including isoflurane. The drug is designed to be administered to a subject shortly after they have suffered brain trauma in order to reduce secondary brain injuries that can lead to neurological deficits.
Incannex is a Melbourne-based clinical-stage pharmaceutical company dedicated to producing unique medicinal cannabis products and psychedelic medicine therapies for treating a broad range of health conditions. Anxiety disorders, inflammatory bowel disease, obstructive sleep apnoea (OSA), rheumatoid arthritis and traumatic brain injuries are examples.
Curia (formerly known as AMRI before 2021) describes itself as a global contract research, development and manufacturing organization (CDMO) offering products and services across the drug development spectrum. The company says that it partners with biotechnology and pharmaceutical companies to amplify business performance and have a positive impact on the lives of patients.
Curia was originally most well-known for its discovery and development of Allegra allergy medication.
Incannex claims that the combination of CBD and isoflurane present in IHL-216A will significantly reduce the negative impact of TBI on subjects once administered. The company announced in May that IHL-216A had demonstrated the ability to restore memory and spatial learning losses associated with brain injuries to a greater extent than either isoflurane or CBD alone in a rodent experiment/study replicating sports concussion impacts.
“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,” said Dr. Mark Bleackley, Chief Scientific Officer at Incannex.
“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,” he added.
An international patent application entitled “Compositions and Methods for the Treatment or Prevention of Traumatic Brain Injury” has been filed as part of the IHL-216A development program, according to Incannex. The company also claims the aforementioned patent application has moved into the national phase in several jurisdictions and that a second patent for the unique formulation and composition of the new drug has also been filed.
Curia plans to catalogue data regarding the stability and quality of the new inhalable drug to assist with regulatory filings going forward, including a United States Food and Drug Administration (FDA) pre-investigational new drug (IND) package and ensuing IND application.
Incannex says that the first cGMP batch of the drug produced by Curia will be utilized in a phase 1 clinical trial beginning once feedback regarding the suggested IHL-216A development proposition has been received from the FDA in a pre-IND consultation that the company plans on holding with the FDA in Q3 this year.
“Curia is honoured to be partnering with Incannex as it addresses an area of unmet patient need. We look forward to our scientific collaboration to help advance this potential treatment from idea to impact,” said Chris Conway, President of Research & Development at Curia