Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL)’s phase 1 trial recently found that IHL-675A cannabinoid combination therapy (cannabidiol (CBD) and hydroxychloroquine (HCQ)) was well tolerated in healthy volunteers with no serious adverse events reported.
Following these positive results, Incannex will continue to progress the development of IHL-675A and is now gearing towards the initiation of a Phase II study, initially focusing on rheumatoid arthritis patients.
HCQ (Plaquenil) has already received FDA approval for the treatment of rheumatoid arthritis as a monotherapy, so Edison Investment Research views management’s decision to prioritise development in this indication as a sensible clinical strategy.
The following is an extract from Edison’s research update:
Incannex has announced encouraging safety data from the Australian Phase I trial for its anti-inflammatory drug IHL-675A, having successfully completed patient dosing. The study found that IHL-675A cannabinoid combination therapy (cannabidiol (CBD) and hydroxychloroquine (HCQ)) was well tolerated in healthy volunteers with no serious adverse events reported. Following these positive results, Incannex will continue to progress the development of IHL-675A and is now gearing towards the initiation of a Phase II study, initially focusing on rheumatoid arthritis patients. HCQ (Plaquenil) has already received FDA approval for the treatment of rheumatoid arthritis as a monotherapy, so we view management’s decision to prioritise development in this indication as a sensible clinical strategy. Additionally, global sales of rheumatoid arthritis drugs reached c US$30bn (source: EvaluatePharma) in 2021, highlighting the potential opportunity in this target market. We value Incannex at US$714.7m or US$11.74 per ADR.
As a reminder, IHL-675A is a combinational regime being investigated for the treatment of three major indications: rheumatoid arthritis, inflammatory bowel disease and lung inflammation, having previously demonstrated anti-inflammatory activity in preclinical studies. The Phase I trial began patient enrolment in August, recruiting three patient cohorts (n=12 per cohort), with each group being treated with either IHL-675A, CBD or HCQ. Patients will continue to be monitored until the end of October 2022. However, to date, no serious adverse events have been recorded from each of the study arms.
With these results, management intends to open a pre-investigational new drug (IND) meeting with the FDA to discuss the clinical development of IHL-675A. Details of the follow-on Phase II Australian study will be announced following trial commencement. However, the trial will look to recruit up to 100 participants and, in parallel, Incannex intends to open an IND that will allow the initiation of FDAregulated studies in rheumatoid arthritis. In our view, positive data from the Phase II study will significantly support the application of future FDA trials. The company has also commenced planning for Australian Phase II trials in inflammatory bowel disease and lung inflammation.
This latest announcement marks what has been a period of positive newsflow for Incannex, which has recently released details of a successful pre-IND FDA meeting for its preclinical asset IHL-216A, to treat traumatic brain injury, which we anticipate is nearing entry into the clinic.