The Incannex Healthcare Ltd (ASX: IHL) share price is climbing on the back of a positive update regarding its therapy, IHL-675A.
At the time of writing, the healthcare company's shares are up 5%, trading at 21 cents.
Image source: Getty Images
What did Incannex announce?
The Incannex share price is on the move today as investors appear pleased with the company's progress.
In its release, Incannex advised that it has been granted a pre-IND meeting with the United States Food and Drug Administration (FDA). The meeting follows the company's submitted information package, which contained details of IHL-675A and its medical benefits.
IHL-675A is a novel therapy that comprises hydroxychloroquine (HCQ) and cannabidiol (CBD) for the potential treatment of Acute Respiratory Distress Syndrome (ARDS) and sepsis-associated Adult Respiratory Distress Syndrome (SAARDS).
Incannex stated that the FDA is scheduled to provide feedback on the development proposal for IHL-675A by 21 April 2021. Once received, the company will seek to finalise clinical development plans with suggestions from the FDA.
The purpose of the pre-IND meeting is to explore the fastest pathway for IHL-675A to be given its registration stamp.
ARDS is a type of respiratory failure which collects fluid into the air sacs of the lungs. This is often caused by infection or trauma and can result in death if not treated. It is estimated that 10% to 15% of patients admitted to intensive care suffering from ARDS.
SAARDS, caused by infection, is associated with lung, urinary tract, stomach, skin infections and COVID-19 viral infections.
Management commentary
Incannex CEO and managing director Joel Latham welcomed the positive outcome, saying:
The United States is the largest pharmaceutical market in the world, so being granted a Pre-IND meeting review with FDA represents an important milestone for our company and a strong foundation for the clinical development of IHL-675A.
Our preclinical studies have demonstrated that IHL-675A has the potential to be a platform drug applicable to the treatment of multiple indications. We anticipate that the work completed on the FDA information package for IHL-675A for ARDS and SAARDS will assist us with hastening submissions to FDA for the other indications being pursued.
About the Incannex share price
The Incannex share price has gained more than 500% in the past 12 months and is up almost 30% year-to-date. The company's shares reached a multi-year high of 29.5 cents in the last month.
Incannex commands a market capitalisation of around $211 million, with roughly 1 billion shares on issue.
