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- Incannex Healthcare (IHL) is expanding its development program to assess the potential for its IHL-65A candidate to become a multi-use pharmaceutical drug
- The decision follows a pre-investigational new drug application meeting with the U.S. Food and Drug Administration (FDA) to discuss its regulatory development in the United States
- So far, Incannex has reported positive pre-clinical results from five distinct in-vivo assessments of IHL-675A, applicable to various disorders caused by excessive inflammation
- IHL has prioritised several indications for clinical assessment, including acute respiratory distress syndrome (ARDS) and sepsis-associated ARDS; pulmonary neutrophilia; inflammatory bowel disease; and rheumatoid arthritis
- With guidance from the FDA, Incannex has now commenced designing a phase one clinical trial, necessary to assess these conditions in humans
- Previously limited to COVID-19 patients with ARDS, IHL has expanded its development program to include other inflammatory disorders in light of the U.S. vaccine roll-out
- The FDA has agreed on marketing applications that will result in an accelerated and less costly route to the drug being approved
- Incannex shares are down 1.72 per cent and are trading at 28.5 cents
Incannex Healthcare (IHL) is expanding its development program to assess the potential for its IHL-65A candidate to become a multi-use pharmaceutical drug.
The decision follows a pre-investigational new drug application meeting with the U.S. Food and Drug Administration (FDA) to discuss regulatory development of the drug in the United States.
So far, Incannex has reported positive pre-clinical results from five distinct in-vivo assessments of IHL-675A, applicable to various disorders caused by excessive inflammation.
Accordingly, the clinical-stage pharmaceutical drug developer has prioritised several indications for clinical assessment, including acute respiratory distress syndrome (ARDS) and sepsis-associated ARDS; pulmonary neutrophilia; inflammatory bowel disease; and rheumatoid arthritis.
With guidance from the FDA, Incannex has now commenced designing a phase one clinical trial which is necessary to assess the conditions in humans.
The trial will form part of three distinct investigational new drug applications (INDs) and associated studies required to gain registration and marketing authority.
Lung inflammation program
Moving forward, the company has resolved to combine its ARDS/SAARDS and pulmonary neutrophilia development activities into a common project and IND, referred to as the lung inflammation program.
The expanded program contrasts with the former plan to pursue an emergency use authorisation (EUA) IND for only ARDS patients with COVID-19.
EUAs are conditional on the continuance of the state of emergency in the U.S. and subject to revocation by the FDA when the emergency subsides.
Incannex recognises that the rapid roll-out of more than 210 million doses of COVID-19 vaccines in the U.S. has significantly improved the outlook of the pandemic this year.
Further, it says the use of vaccines has shortened the expected time in which therapies with EUA approval can persist without having to achieve full product registration.
For this reason, the company chose not to limit the development program to COVID-19 ARDS patients only.
Instead, IHL says its newly combined program and single IND submission have markedly increased the patient cohort, thereby increasing the scope and economic potential of the program.
Incannex Managing Director Joel Latham commented on the FDA meeting’s outcomes.
“The directors of Incannex are delighted with the positive feedback and encouragement from the FDA at the PIND meeting and will now move forward with conviction on our clinical programs to develop IHL-675A as a multi-use pharmaceutical,” he said.
“The combined annual global market size of the indications being targeted by Incannex with IHL-675A is over US$125 billion, so we consider the economic potential, as well as the benefit to patients over incumbent treatments, to be enormous.”
The FDA has agreed on marketing applications that will result in an accelerated and less costly route to approval for the drug.
Incannex shares are down 1.72 per cent and are trading at 28.5 cents at 10:19 am AEST.
