Special Report: Along with Phase 1 trials for IHL-675A, the company also received a positive response with respect to its global patent application from the Patent Examiner.

Incannex Healthcare (ASX:IHL) announced the latest key update for its IHL-675A treatment this morning, with the commencement of its Phase 1 clinical trial.

The trial is the culmination of an extensive period of pre-development for IHL-675A, which has proven its potential as a multi-use drug candidate for the prevention and treatment of inflammatory lung conditions, rheumatoid arthritis, and inflammatory bowel disease.

IHL-675A is a combination treatment consisting of the registered pharmaceutical agent  hydroxychloroquine (HCQ) and cannabidiol (CBD).

Combined together, four separate in vivo studies show that the two components work synergistically to inhibit inflammation.

The Phase I trial will now assess the IHL-675A soft gel capsules in healthy patients, as Incannex moves towards clinical validation for its product in a global anti-inflammatory market that exceeds US$125 billion per year.


Phase 1 trials

IHL’s Phase 1 trial will be carried out at the CMAX Clinical Research Centre in South Australia.

A total of 36 subjects will participate in the trial, divided evenly into three groups of 12 who will be allocated a separate treatment – IHL-675A, CBD or HCQ.

The aims of the study are to “demonstrate that there are no, or minimal, additional side effects associated with the combination of CBD and HCQ compared to each drug alone, and that the uptake and metabolism (pharmacokinetics) of the two drugs do not materially interfere with one another”, IHL said.

The company anticipates that the first patients for the trial will be recruited in the December quarter.

The trial will be managed by Avance Clinical, which is the largest full-service contract research organisation (CRO) in Australia.

A specialist in early-stage biotech research, Avance has 24 years of experience with a full clinic team to support development through to Phase 1 and 2 clinical trials.

“With experience across more than 105 indications the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review,” IHL said.

In the event of a successful clinical result, the trial will form part of the three investigational new drug (IND) applications that Incannex has filed with the US FDA for IHL-675A, for each of its treatment applications; lung inflammation, rheumatoid arthritis, and inflammatory bowel disease.


Patent protection

Along with the commencement of Phase 1 trials, Incannex has taken detailed steps to ensure it secures intellectual property (IP) protection for the IHL-675A treatment.

As part of its development program, the company recently filed an International Patent Application called “Methods and compositions for treating or preventing an inflammatory condition”.

The patent was filed in accordance with the Patent Cooperation Treaty, which will give IHL patent protection in multiple global markets including the US, Europe, Japan and Australia.

In light of its application, IHL advised the market that it has received a response from the International Examiner.

The examiner’s report considered that the “claims directed to IHL-675A, and methods for the treatment of inflammatory conditions using IHL-675A, are novel and inventive and meet the requirements for industrial applicability”, Incannex said.

Upon receipt of the International Search Report and Opinion, IHL is now considering options to expedite the patent application process as part of its broader intellectual property strategy.

The promising news for IHL-675A marks a continuation of Incannex’s patent strategy across its product suite, where applications have also been filed for its IHL-216A concussion treatment and its IHL-42X sleep apnoea treatment.

This article was developed in collaboration with Incannex Healthcare, 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.