Medical cannabis company Impression Healthcare (ASX: IHL) has confirmed plans to bring its novel cannabinoid formula IHL-216A for patients with traumatic brain injury to the prescription market within the next three years.
The company commissioned advisory firm Camargo Pharmaceuticals Services to provide an independent strategic assessment report on the US Food & Drug Administration approval pathway for the cannabinoid to allow for the treatment of secondary brain injuries associated with TBI and concussion.
Camargo has since affirmed its ability to make an FDA 505(2)(b) new drug application for the drug, raising the prospect of reduced time and cost to commercialisation, subject to a successful phase 2b clinical trial.
Carmargo’s report also suggested that Impression should seek to apply for one or more of the FDA’s expedited review programs, which further assists to fast-track the development of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions.
The program would further hasten the drug review process and reduce the time to market.
In the meantime, unregistered sales of IHL-216A may be achievable through US and Canadian dispensaries and also via the Special Access Scheme in Australia, which is a Therapeutic Goods of Australia pathway available to access “unapproved” medications.
Traumatic brain injury
IHL-216A is being assessed for its ability to protect the brain against injury mechanisms which cause cell death and other negative consequences in the weeks and months following incidences of head trauma.
Research shows traumatic brain injury accounts for approximately 10 million deaths and/or hospitalisations worldwide each year.
There are currently no approved drugs available for these patients, with current treatment for severe injuries including a highly-invasive procedure known as decompressive craniotomy which drills into the skull to drain fluid.
Secondary brain injuries can evolve over minutes, days or months after the first injury and result from biochemical, metabolic and cellular changes initiated by the primary event.
Secondary injury cascades are thought to account for the development of many of the neurological deficits observed after a traumatic brain injury episode.
Their delayed nature suggests there may be a therapeutic window for treatment to prevent progressive tissue damage and improve patient outcomes.
Impression believes IHL-216A could potentially be administered in the immediate period after primary injury to the prevent development of secondary problems.
Phase 2b trial
Earlier this year, Impression announced plans for a phase 2b clinical trial of IHL-216A using a group of mixed martial arts fighters who receive frequent knocks to the head and show symptoms of traumatic brain injury and concussion.
The trial will investigate neurocognitive function in up to 50 participants who have sustained a concussion, comparing those who receive IHL-216A to those receiving a placebo.
Concussions will be diagnosed and ranked with the aid of Impression’s FitGuard concussive measuring smart mouthguard and FDA-recognised neurocognitive and neuroradiological tests.
Baseline neurocognitive tests covering attention, memory, language, reaction time and perception will be completed by each participant and repeated at various junctures post-trauma to compare IHL-216A and placebo cohorts.
Along with measuring duration to recovery (also known as “return to play”), clinical trial endpoints will include an array of brain-injury related blood biomarkers.
The trial is expected to commence in the third quarter this year but animal studies will commence sooner and in the current quarter.