PANIC DISORDER TRIALS

The phase 2 trial for panic disorder is planned to commence in early 2023.

From a layman’s perspective, panic disorder is a type of anxiety disorder with no known cause or cure.

An attack usually passes in 5 to 10 minutes, but it can linger for hours. It can feel like you’re having a heart attack or a stroke.

One in 10 adults in the U.S. have a panic attack each year and they usually begin between the ages of 15 and 25.

We’ve seen some first-hand accounts in the media recently with ex-AFL footballer, Tom Boyd, who quit the game at the peak of his powers and left behind a multi-million dollar contract.
AFL: Tom Boyd reveals ongoing battle with anxiety, panic attacks, Western Bulldogs (nine.com.au)

Existing treatments are less than satisfactory.

Psychotherapy is uncomfortable and time consuming. Current drugs are slow acting and are accompanied by unwanted side-effects.

Based on what we can glean from IHL’s experiences, the company will likely combine an existing off-patent medication with an off-patent CBD medication with the aim to produce positive synergistic effects for improved patient outcomes.

The genius of this route, the IHL playbook, is it saves a lot of time & money because trials for the existing off-patent medicines do not need to be replicated. The company only has to test for synergistic effects of the combination drugs.

The pot of gold is the company can patent the combination drug.

The company states the TAM is USD$45 billion.

I’d argue it’s much, much higher because that figure assumes only patients with panic disorder will use the combination drug if it’s successful.

I think we will find the drug will be used proactively, not just reactionary.

There will be known situations which are more likely to bring on an anxiety episode. Why not get in ahead and inhale a puff or two, calm the nerves and save the trauma of a panic attack before it occurs?

Moreover, will its use be limited to only patients diagnosed with panic disorder?
"About a third of people have one in their lifetime, but most of them don’t have panic disorder."
Panic Disorder and Panic Attacks (webmd.com)

Who doesn’t have high anxiety moments in life from time to time? Think of the anxiety public speaking, job interviews, first meetings, challenging times at work, financial hardship, social functions, moving houses, flying on airplanes, break ups & divorce can cause people who don't have panic disorder.

Maybe a fast-acting medicine which can help calm the nerves, anxiety and negative thoughts may be of value to many people in the community struggling in one of the above situations?

Especially, because the combination drug contains no THC, so many handbrakes are removed. For examples, much of the red tape in importing the medical cannabis component disappears and working or driving on the medication is a complete non-issue.

Equally important, because the drug is taken via a socially accepted and discreet inhaler, not only are the effects almost immediate, the drug can be taken anywhere anytime – even in a restaurant or on an airplane.

The market is wide open for anyone to use, even teenagers.

In terms of progress, the pMDI has been selected, the company has recently completed initial formulation work for its panic disorder medication, with solubility and spray characteristics now determined and stability testing is currently underway with very encouraging results. Premier Research (formerly Camargo) are on the job to fast track approval pathways with the FDA.

It is expected that Phase 2 clinical trials will commence with the first patient is anticipated to be between Feb-April 2023.

The ASX is littered with cannabis companies that rely on hype because that’s all they’ve got. By contrast, the world class executive team of IRX is highly skilled and experienced, and includes Dr Sud Agarwal (Cannvalate), Dr Andrew Saich (ex-GW Pharma) and Vijay Sappani (TerraAscend).

The register is tightly held and the top 20 own over 70%.

In terms of what to expect that might trigger a re-rate, I think all the building blocks are already in place now, so we are simply waiting for news flow.

One would expect the news flow to start as the trial fast approaches.

Imho