Incannex to target 3 major markets with its IHL-675A following pre-IND with the US FDA; enable a less costly and faster 505(b)(2) FDA registration pathway
2021-04-23 01:11:15 (AET) by Ring Zhang 572
Incannex (ASX: IHL) has decided to target 3 major markets with its drug called IHL-675A following pre-IND with the US Food and Drug Administration and confirmed its eligibility for a less costly and faster FDA registration pathway.
Incannex Healthcare Limited (ASX: IHL), an ASX-Listed pharmaceutical development company, has reported tremendous progress associated with its drug candidate IHL-675A’s drug indication expansion and FDA registration pathway, following a successful Pre-Investigational New Drug Application meeting (‘PIND’) with the US Food and Drug Administration (‘FDA’), the world’s most respected pharmaceutical regulator.
Following the guidance from the FDA meeting, IHL announced the following key results from discussions:
1. IHL to target three new New Drug Applications for IHL-675A
Following the guidance from FDA, IHL confirmed that it will undertake clinical programs to work towards submitting three new New Drug Applications for IHL-675A for lung inflammation, inflammatory bowel disease and rheumatoid arthritis, to unlock the potential for the drug candidate to become a multi-use medicine.
Multiple in vivo studies conducted by IHL have provided substantial pre-clinical evidence that the drug candidate possesses strong anti-inflammatory effect against various disorders caused by excessive inflammation. IHL-675A is applicable to acute respiratory distress syndrome (ARDS) and sepsis associated ARDS (SAARDS), pulmonary neutrophilia (primary underlying cause of COPD, asthma, and bronchitis), inflammatory bowel disease and rheumatoid arthritis.
The studies for Acute respiratory distress syndrome (ARDS), sepsis associated ARDS (SAARDS) and pulmonary neutrophilia (COPD, asthma, and bronchitis) will be combined into one development program and become the lung inflammation indication.
Combining the two study programs into a single IND submission not only markedly increases the patient cohort to include those with bronchitis, asthma, COPD, SAARDS, ARDS and COVID-19 ARDS, but also dramatically upsizes the scope and economic potential of the program.
The other two development programs and INDs will be for inflammatory bowel disease and rheumatoid arthritis. IHL is in the process of designing a phase 1 trial that will inform and be a part of all three development programs and INDs in the future, subject to clinical success.
2. EUA submission remains as an option
In a previous announcement, IHL has mentioned an intention to purse an Emergency Use Authorisation (‘EUA’) IND for only ARDS patients with COVID-19, and the decision to reform the lung development program has contrasted with the original plan.
Further to that, the company commented that the rapid roll-out of COVID-19 vaccination across the United State may have impact on the continuance of the EUA program and doesn’t wish to limit its development program to only COVID-19 ARDS. Submitting an EUA application for COVID-19 ARDS remains an option during the lung development program, should the pandemic outlook worsen in the US.
3. Eligibility for 505(b)(2) application confirmed
Most importantly, the FDA panel has agreed that marketing applications for IHL-675A should be 505(b)(2) applications. Compared to the traditional 505(b)(1) pathway, the 505(b)(2) allows the usage of historical studies not conducted IHL as the reference of the safety and effectiveness report. This will result in a less costly and faster route to FDA approval.
IHL also reported that the FDA provided it guidance on the design of the clinical trials, including opinions on the selection of clinical trial endpoints, to ensure the most efficient clinical development plan to be included in the three IHL-675A IND applications.
Incannex CEO and Managing Director, Mr Joel Latham, said; “the directors of Incannex are delighted with the positive feedback and encouragement from the FDA…the combined annual global market size of the indications being targeted by Incannex with IHL-675A is over US$125Bso we consider the economic potential, as well as the benefit to patients over incumbent treatments, to be enormous”.
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