By Chris Wack

 

Incannex Healthcare Ltd. said it has completed a highly constructive pre-Investigational New Drug application meeting with the U.S. Food and Drug Administration to discuss the development IHL-42X.

IHL-42X is a fixed dose combination of dronabinol and acetazolamide that is being developed as a treatment for obstructive sleep apnoea in adults.

Incannex said it submitted a pre-IND meeting package and meeting request to the FDA in February, which included an overview of the development program, and specific questions Incannex had on the regulatory requirements for opening an investigational new drug application.

The company said the written responses, and the responses provided in a teleconference with FDA representatives, were constructive and supportive, with interest in the project underpinned by the significant cohort of people diagnosed with OSA and the absence of pharmacological treatment solutions.

The FDA provided guidance on Incannex's proposed long-term development strategy, including specific parameters to demonstrate safety and efficacy in phase 2 and 3 pivotal studies.

In a decision that will save Incannex time and cost, the FDA agreed that Incannex doesn't need to conduct studies in animals, confirming that animal toxicology and animal pharmacokinetic studies aren't required for opening an IND for IHL-42X. Therefore, the next step for the development of IHL-42X will be the adjustment of clinical trial designs and arrangement of operational imperatives necessary to open an IND with FDA.

Incannex shares were up 5% to $7.99 in premarket trading.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

May 17, 2022 08:26 ET (12:26 GMT)

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