After completing patient dosing in its Phase 1 clinical trial of anti-inflammatory IHL-675A, Incannex Healthcare has advanced to Phase 2 trials.

Clinical stage pharmaceutical cannabinoid and psychedelics company Incannex Healthcare (ASX:IHL) has completed the Phase 1 clinical trial measuring the safety, tolerability, and pharmacokinetic profiles of its anti-inflammatory IHL-675A.

IHL-675A is a combination cannabinoid drug comprising cannabidiol (CBD) and hydroxychloroquine (HCQ) in a fixed dose combination.

IHL-675A has been well tolerated, with no adverse event of concern reported to date.

IHL is arranging Phase 2 studies for patients with rheumatoid arthritis.

The company is also planning Phase 2 studies for patients with inflammatory bowel disease and lung inflammation.

IHL is preparing for a pre-IND meeting with the FDA on the development of IHL-675A specifically for the treatment of patients with arthritis.

It intends to open an IND in parallel with the Australian Phase 2 study.

IHL chief scientific officer Dr Mark Bleackley said it was an exciting opportunity for the company to complete dosing in its Phase 1 study for IHL-675A because it has so many potential therapeutic uses.

“At this stage, there have been no unexpected adverse events and the drug appears to be well tolerated,” he said.

“This gives our team the confidence to take the next steps to commence Phase 2 clinical trials, initially in patients with arthritis, then in patients with lung inflammation and inflammatory bowel disease.”

Incannex achieves key FDA milestone

In further good news for the company, IHL earlier this week announced it is on track to advance its inhaled drug product for the treatment of traumatic brain injury and concussion (TBI) with positive vital feedback from the US Food and Drug Administration (FDA).

The company has completed a constructive pre-Investigational New Drug application (pre-IND) meeting with the FDA.

The meeting is for its proprietary drug IHL-216A, which combines cannabidiol (CBD) with any volatile anaesthetic agent, including isoflurane (ISO) for TBI.

IHL submitted a pre-IND meeting package to the FDA in August 2022. The meeting package included a description of the formulation, an overview of the proposed clinical development plan and specific questions on the regulatory requirements for opening an IND.

Opening an IND is required to conduct trials in the US and ensures that trials are designed to meet the data requirements necessary for FDA marketing approval.

In written correspondence, FDA provided valuable, multidisciplinary feedback on the proposed clinical development of IHL-216A and acknowledged that treatment of TBI is a significant unmet medical need that requires innovative treatment solutions.

The FDA also confirmed that the FDA505(b)2 application was the appropriate regulatory pathway for IHL-216A, whereby some of the information required for marketing approval may derive from studies already completed on the drug components of IHL-216A and in the public domain.

FDA provided critical guidance on the data requirements for opening an IND for IHL-216A, particularly related to the intricacies of developing an inhaled drug product and conducting clinical trials that involve an anaesthetic.

Follow-up now underway

IHL is now drafting a follow-up request for additional information on the FDA’s recommendations.

The pre-IND meeting indicated that the agency is highly interested in the development of IHL-216A for treatment of TBI.

The company said its responses covered all aspects of the proposed development and engaged a range of disciplinary experts that provided useful insight on all aspects of the development plan.

The FDA  has  provided  essential  advice  on  inhaled  drug  development  that  will  guide  the  most  efficient development of IHL-216A.

Positive early results

IHL-216A has demonstrated neuroprotective activity in two separate animal models of traumatic brain injury, one representing moderate to severe injury and the other representing mild injury, or concussion.

In both models, treatment with IHL-216A improved the effects of injury to a greater extent than either CBD or ISO monotherapy.

In May IHL released the results of an extensive animal study that compared IHL-216A to its component drugs, CBD, and ISO, in a model developed in collaboration with the US National Football League (NFL).

In that experiment, IHL-216A was observed to restore spatial memory after 24 hours in injured rodents. Injured rodents that only received the vehicle as treatment did not display restored spatial memory.

IHL is a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs.

Transformative year for IHL

These latest achievements come in what has been a year of accomplishments for IHL. In September the company was included in the S&P/ASX300 index and in February made its Nasdaq debut with a dual listing to attract medicinal cannabis investors as it pursues North American growth.

The company acquired leading cannabinoid biotech company APIRx Pharmaceuticals (APIRx), to further strengthens its global position in the cannabinoid and psychedelic sectors.

It also appointed recently appointed former Pfizer and now Novo Nordisk A/S vice president, US regulatory affairs Robert B. Clark to its board as a non-executive director.

This article was developed in collaboration with Incannex, a Stockhead advertiser at the time of publishing.  

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.