Incannex Healthcare has completed a constructive pre-Investigational New Drug Application (pre-IND) meeting with the US Food and Drug Administration (FDA) for its proprietary drug product IHL-675A for treatment of rheumatoid arthritis (RA).

IHL-675A is a proprietary combination product of  Incannex Healthcare (ASX:IHL) containing cannabidiol (CBD) and hydroxychloroquine sulfate (HCQ) for treatment of inflammatory disorders including RA.

IHL submitted a pre-IND meeting package to the FDA in June 2023 including a description of the unique formulation developed by the company and an overview of its proposed clinical development plan.

It also submitted specific questions on the regulatory requirements for opening an Investigational New Drug (IND) application.

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

Pathway for IHL-675A clinical development

IHL says in the written correspondence the FDA provided valuable, multidisciplinary feedback on the proposed clinical development of IHL-675A.

Importantly, the FDA confirmed that no further nonclinical studies are needed for. the IND application.

The FDA also provided specific guidance on what is required for IHL to submit an NDA via the 505(b)(2) pathway, whereby some of the information required for marketing approval is derived from published studies on  the  components  of  IHL-675A and/or  the agency’s findings on safety and/or effectiveness for relevant listed drugs.

IHL says the FDA provided critical guidance on the proposed clinical development plan for IHL-675A, which it is incorporating into its clinical trial designs and the overarching strategy for the drug’s development.

Chief Scientific Officer of Incannex, Dr. Mark Bleackley, says feedback received from the FDA in the pre-IND  meeting is highly  valuable for the  continued  development  of  IHL-675A  for  treatment  of rheumatoid arthritis.

“The agency’s responses covered multiple aspects of our development strategy that will be incorporated into our clinical trial designs and research plans.

“We look forward to continuing to work with the FDA to ensure that the IHL-675A development program generates high quality data that addresses the requirements set forth by the agency.”

Phase-2 trial underway

IHL is currently conducting a Phase-2 clinical trial assessing IHL-675A in patients with RA at 8-10 sites in Australia and New Zealand.

The trial will include 128 participants who meet the eligibility criteria and is designed to include patients who have on-going pain and reduced function while on stable treatment for their RA.

The Phase-2 trial follows a successful Phase-1 clinical trial whereby both active pharmaceutical ingredients cannabidiol (CBD) and hydroxychloroquine sulphate (HCQ) were absorbed from IHL’s fixed dose combination product IHL-675A.

The drug product was also observed to be well tolerated, with no adverse events of concern. Before starting  clinical  trials, IHL  observed  positive  results  from  an  animal model  of  RA.

IHL-675A was observed to be more effective at reducing RA across multiple disease assessments including clinical score, paw volume, pannus score, total histology score and serum  cytokine  levels  than  the  rodent equivalent of the standard dose of HCQ or equivalent doses of CBD.

In further good news for the company, this week IHL also announced it had successfully submitted an IND application to the FDA for IHL-42X for treatment of obstructive sleep apnoea.

The IND dossier compiled by the IHL team includes comprehensive modules on the safety and efficacy of IHL-42X and its component active  pharmaceutical ingredients.

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.

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