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- Incannex Healthcare (IHL) has been granted a pre-investigational new drug (IND) meeting with the U.S. Food and Drug Administration (FDA)
- The meeting is regarding IHL-675A and its use in preventing Acute Respiratory Distress Syndrome (ARDS) and Sepsis Associated Acute Respiratory Distress Syndrome (SAARDS)
- FDA intends to provide a comment on IHL-675A by April 21, after which Incannex will formalise its clinical development plan
- On the market this morning, Incannex is up 2.50 per cent and is trading at 20.5 cents per share
Incannex Healthcare (IHL) has been granted a pre investigational new drug (IND) meeting with the U.S. Food and Drug Administration (FDA).
The meeting is regarding IHL-675A and its use in preventing Acute Respiratory Distress Syndrome (ARDS) and Sepsis Associated Acute Respiratory Distress Syndrome (SAARDS).
ARDS is a life-threatening injury characterised by fluid leakage into the lungs, caused by lung injury due to trauma. Around 10 to 15 per cent of patients admitted to intensive care have ARDS.
SAARDS is a leading cause of mortality associated with lung, urinary tract, stomach, skin infections and SARS-CoV-2.
Patients diagnosed with ARDS currently have poor treatment outcomes and standard treatment continues to use oxygen ventilators to treat symptoms but does not treat fluid leakage.
The purpose of the meeting is to obtain regulatory guidance and agreement on the most efficient clinical development plan.
FDA has indicated a goal date for providing comment on IHL-675A by April 21, after which Incannex will formalise its clinical development plan.
“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,” CEO Joel Latham said.
“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,” he added.
On the market this morning, Incannex is up 2.50 per cent and is trading at 20.5 cents per share at 10:17 am AEDT.
