Thought it a very pertinent time to detail for new shareholders a little background on IHL-42X which is being developed by Incannex.
Pertinent, because we are waiting for an update from the FDA Pre-Ind meeting on 11th May (US Time)
I am guessing that the BOD is digesting the FDA guidance ATM and will give shareholders an update in the coming days.
I have transcribed, the Podcast between Jeff Cone and CEO Joel Latham
https://thewallstreetresource.com/webcasts/dated Monday, May 9, 2022, an invaluable insight for new shareholders.
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This is Jeff Cone with the Wall Street Resource. Joining me is Joel Latham. He's the CEO of Incannex Health Care.
> Hello, Joel.
Jeff. A pleasure to meet you.
> So welcome. For those that aren't familiar with Incannex Healthcare, can you give us a quick overview of the company?
Of course. Incannex is a global biotech company developing cannabinoid and psychedelic compound medicines. Our mission is to create Premier pharmaceutical drugs and therapies restoring health and transforming the lives of patients with unmet medical needs. We are developing targeted and scientifically validated products, creating long-term value for our patients and shareholders.
We're a dual-listed company. We listed our company firstly on the ASX here in Australia back in 2016 and pleasingly. We achieved our Nasdaq listing in February.
> So it sounds like you're definitely not in just another CBD company.
No, definitely not. So we have developed proprietary combination products targeting indications that have limited or unmet treatment options available to patients. So we've developed quite a robust IP strategy ensuring that we have IP coverage over our proprietary combination products targeting these unmet medical needs.
So as it stands currently we have six developmental projects in our clinical developmental pipeline. So across those six projects, we're targeting $110,000,000,000 annually of unmet medical needs. So the indications that we're targeting are
- obstructive sleep apnea,
- traumatic brain injury,
- inflammatory lung conditions,
- rheumatoid arthritis,
- inflammatory bowel disease and
- generalized anxiety disorder.
So treatment for any one of these conditions have massive potential as the markets we are targeting huge success in just one development program provides significant investor value and given that we have six programs running in parallel, we have news flow imminent over the coming months and years due to having each of these programs running at once. So it is quite a unique offering.
> So you have a lot going on. So let's talk about what your lead candidate is.
For sure. So it's IHL-42X We're targeting obstructive sleep apnea.
So obstructive sleep apnea is categorized by the narrowing or the obstruction of the upper airway in sleep. This interferes and interrupts with breathing, resulting in decreased oxygen uptake and poor quality of sleep. This is a relatively common and chronic disorder and is largely undiagnosed and untreated. The pharmacy therapy for OSA has had limited success as effective agents have not yet been identified. This treatment option currently is a CPAP machine that splits the airway open to prevent disruptions in breathing. However, CPAP is not well tolerated by many patients due to discomfort, claustrophobia and the noise of the machine.
So here at Incannex, we have designed IHL-42X, a combination of dronabinol, which is synthetic THC, and acetazolamide for the treatment of obstructive sleep apnea. Both dronabinol and acetazolamide are clinically proven to reduce the Apnea-Hypopnea Index, which is the measure used for diagnosis and monitoring of obstructive sleep apnea.
However, they have both have had limited efficacy in most studies as well as unwanted side effects and efficacious doses. So dronabinol and acetazolamide affect OSA through different pathways, the dronabinol binds to the cannabinoid receptors, modulates signaling, and activates muscles that dilate the Airways, whereas acetazolamide induces metabolic acidosis, which signals to the body that there is excess CO2 in the blood, inducing and taking of a breath. So IHL is intended to decrease the required dose of each of the component drugs by targeting two mechanisms for reducing Ahi simultaneously.
So pleasingly for the company. We've recently completed a phase two clinical study. The results that we received far exceeded our expectations. So 20% of the patient cohorts experienced over 80% reduction in their Ahi, and 60% of patients in the trial experienced a reduction of over 50%. So these are truly groundbreaking results considering that there are no registered pharmaceutical treatment options available to patients currently. And we're targeting a $10 billion addressable market. Pleasingly for the company. We have a pre Ind meeting with the FDA next week, (11th May) so we look forward to receiving feedback from the FDA, presenting our clinical development plan, and fast-tracking the registration of this product with the FDA. As we continue to hopefully have clinical success,
we're planning on having a blended phase two, phase three clinical trial kick-off by the back end of this year.
So there are a few milestones between now and then, and the team are working hard in the background because we know, given the results that we've received, that we're well and truly onto something with our leader.
> In terms of regulatory pathway. You mentioned the FDA. So you're going for the US. Are you going for additional countries as well initially?
Definitely the US. So the FDA first and foremost is the key target for each of our clinical development projects in our pipeline. Yes. We're an Australian company who is now listed in the US, and a big part of us being listed in the US is because our regulatory strategy centers around the FDA. So each of our clinical development projects are geared toward registration with the FDA. Following success with the FDA, regulatory registration will be sought in other jurisdictions such as Australia, Europe, and other major target markets for us globally.
> Okay. And how is this drug taken?
It's taken orally, so we've created a dual capsule soft gel cap that is to be taken prior to going to sleep. So as I mentioned, the current treatment for obstructive sleep apnea is a CPAP machine, so it's a mask that's cumbersome, can be labor-intensive and socially awkward. It has a higher drop-off rate.
So we've created this solution where it's a soft gel capsule that's to be taken before bed. And we're very excited by the results. And the feedback from the patients that we've had participated in the trial has been great. Their overall life has been improved because they're able to have a quality night's sleep without worrying about wearing a CPAP mask or taking any other pharmaceutical option.
> So what are the endpoints or have you not yet designed that with the FDA?
Definitely. So we're working with the FDA at the moment. So the main endpoint that we're working on, our primary endpoint is the Hypopnea Apnea index. So that's called Ahi. So this measure is used for the diagnosis and monitoring of obstructive sleep right now.
> And then how does the drug work? What's the mechanism of action?
So the dronabinol. So it's a combination product that consists of dronabinol and acetazolamide. So both act in different ways. So the dronabinol binds to the cannabinoid receptors, modulates signaling, and activates muscles that dilate the Airways, whereas acetazolamide induces metabolic acidosis, which signals to the body that there is excess CO2 in the blood, inducing the taking of a breath.
> And then where are the studies taking place and how large are they going to be?
Our first phase two proof of concept study was it took place here in Australia, so we partnered with the University of Western Australia and the Alfred Hospital in Melbourne. So we received 40 Ahi data points throughout the trial, which was great for the business and put us in a position to be able to receive data to essentially proof of concept.
And now we're scaling into our pivotal studies, which will be multisite, multi-jurisdictional throughout the US. So basically we will tailor the clinical development pathway based on the feedback that we received from the FDA next week. But we're proposing to do our pivotal phase two study with in excess of 250 patients, which we expect to kick off by the end of the year.
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Looking forward to learning more about the FDA guidance from 11th May - I like the idea of a blended Pase 2 - Phase 3 study mentioned by Joel in this podcast.
Good luck all holders.
