Incannex Healthcare (ASX:IHL) plans US FDA meeting over positive IHL-216A results – The Market Herald
- Inannex Healthcare (IHL) announces positive results from a preclinical study testing its drug IHL-216A in rodent models
- The study compared IHL-216A to CBD and isoflurane in a study model developed with the US NFL to mimic the type of brain injury that occurs in sports-related concussions.
- IHL-216A restored spatial memory after 24 hours in rodent models, while rats treated with CBD alone experienced only partially restored spatial memory
- Incannex says the results further confirm its drug’s benefits and is accelerating a pre-investigation new drug (IND) meeting with the US FDA later this year
- IHL shares are trading down 7.89% at 35 cents
Incannex Healthcare (IHL) has announced positive results from a preclinical study testing its drug IHL-216A in head trauma.
The study compared IHL-216A to its component drug, cannabidiol (CBD) and isoflurane, using six groups of 24 Sprague Dawley rats.
The study model was developed in conjunction with the US National Football League (NFL) to represent the type of brain injury that can occur in sports-related concussions.
Concussions suffered by NFL players were adapted to rodent subjects to mimic collision mechanisms.
IHL-216A was observed to have a strong neuroprotective effect in that it restored spatial memory after 24 hours in injured rodent models, while those who received only the vehicle as a treatment had not restored spatial memory.
Rats that were treated with CBD alone experienced only partially restored spatial memory, further confirming the benefits of Incannex Healthcare’s new drug combination over CBD alone.
IHL Scientific Director Dr. Mark Bleackley said it was “exciting” that Incannex observed a neuroprotective effect for IHL-216A.
“Combining the results of our two animal studies indicates that IHL-216A has the potential to be effective in reducing the effects of traumatic brain injury across the spectrum of injury severity,” Dr. Bleackley said.
Due to the positive preclinical results, the healthcare stock began preparing a pre-Investigational New Drug (IND) meeting brief for IHL-216A.
The company is targeting a pre-IND meeting with the U.S. Food and Drug Administration (FDA) in the September quarter of 2022. The meeting will discuss Incannex’s plan to conduct a clinical trial for a new drug application and a marketing approval.
IHL fell 7.89% to trade at 35 cents at 11:10 a.m. AEST.