Pharmaceutical cannabis and psychedelic medicine company Incannex Healthcare (ASX:IHL) continues to execute on its multi-channel development pathway for clinically-proven cannabinoid treatments.
And the company announced some more good news this morning, after holding its Pre-Investigational New Drug Application meeting (PIND) with the US Food and Drug Administration (FDA).
Following those discussions, IHL announced today that it will “expand its development program to assess the potential for IHL-675A to become a multi-use pharmaceutical drug applicable to the treatment of patients with lung inflammation, inflammatory bowel disease (IBD) and rheumatoid arthritis”.
The FDA also confirmed that marketing applications for IHL-675 should be done using the 505(b)(2) application process – a less costly and more streamlined development pathway than the traditional 505(b)(1) path.
CEO Joel Latham said the IHL board is “delighted with the positive feedback and encouragement from the FDA”, allowing the company to “now move forward with conviction on our clinical programs”.
The update marks another step forward for the company, following a steady stream of positive developments (and the addition of a psychedelic project with Monash University) which has seen IHL shares rise by more than 500pc since September.
IHL-675 development pathway
Ahead of Incannex’s PIND meeting with the FDA, the company had already obtained positive pre-clinical results for five separate in-vivo assessments of IHL-675, in the treatment of various types of inflammation.
As part of that process, the following indications have been prioritised for clinical assessment:
- Acute respiratory distress syndrome (ARDS) and sepsis associated ARDS (SAARDS);
- pulmonary neutrophilia (the primary underlying cause of COPD, asthma, and bronchitis);
- inflammatory bowel disease, and;
- rheumatoid arthritis.
Following its meeting with the FDA, Incannex will now move development for two treatments – ARDS/SAARDS and pulmonary neutrophilia – into a combined research program and Investigational New Drug (IND).
Inflammatory bowel disease and rheumatoid arthritis will have their own research programs and INDs
Incannex says that the three development programs has increased the scope and economic potential of the program.
Along with its approval for an expanded development pathway, the FDA also advised that IHL’s marketing applications for IHL-675A should be done using 505(b)(2) New Drug Application pathway.
The 505(b)(2) provides guidance for how safety and efficacy information on active ingredients can be approved by historical studies – rather than having to be conducted by Incannex.
The ruling gives Incannex a “less costly and faster route to approval” compared to 505(b)(1) pathway, IHL said, whilst also “creating a new and differentiated commercial product, subject to clinical success”.
“Additionally, the FDA panel provided valuable guidance on the design of clinical trials, including opinions on the selection of clinical trial endpoints,” IHL said.
Latham highlighted that with the results from its PIND meeting, IHL continues to build momentum for its proprietary treatments for what is a major market opportunity.
“The combined annual global market size of the indications being targeted by Incannex with IHL-675A is over US$125 billion,” Latham said.
“So we consider the economic potential — as well as the benefit to patients over incumbent treatments — to be enormous.”
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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