Biocurious: Inhalerx hones in on pot for pain and panic in its quest for historic drug approval

• Inhalerx is focused on a nasal mode of delivery for two underserved but broad indications
• The company is in the throes of trials for breakthrough cancer pain and panic disorder
• Clendon Biotech Capital is backing the dream with a $38.5 million debt facility

ASX minnow InhaleRX (ASX:IRX) is seeking to achieve what has eluded dozens of other cannabis plays: to regulatory approval.

In pursuing inhaled medications for mental health (panic disorder) and cancer pain management, Inhalerx is going about things differently to most of its peers.

The company doesn’t purport to have superior cannabis cultivars, or a unique delivery medium.

The device is a bog-standard pressurised metered dose inhaler, commonly used for asthma. The active synthesised cannabis ingredient is also readily available.

“We are targeting indications where there are insufficient or unmatched treatment options, or they don’t exist at all,” says CEO Darryl Davies.

Inhalerx has no interest in cannabis cultivation, manufacturers and distribution.

“We are focused on the sole goal of getting a drug approved by the FDA [US Food and Drug Administration],” Davies says.

“We have tried to detach ourselves from the ‘pot stock’ category, because a lot of investors have been burnt by listed cannabis companies.”

Pain relief

The company’s first candidate – IRX-211 – is for breakthrough cancer pain (BtCP), which affects about 60% of cancer sufferers.

IRX is an inhaled version of dronabinol, which the FDA has approved for other indications.

Isn’t pain just pain?

“You can be on opioids but still have rapid pain episodes,” Davies says.

“You can get an overwhelming sense of pain in the middle of the night.”

The company intends IRX-211 to have a rapid onset when inhaled – and an equally rapid ‘offset’ when the pain goes away.

Think of it as ‘just in time’ cancer pain management.

IRX-211 contains synthesised THC, pot’s psychoactive ingredient.

To date, a phase I study has supported safety and absorption aspects, while the company gleaned ‘good insights’ into how the device performed.

Davies says the company met with the FDA, in view of an Investigational New Drug application (permission to run a trial under the agency’s auspices).

“Initially we targeted for complex regional pain syndrome  but pivoted to breakthrough pain as result of meeting,” he says.

“We have a very good regulatory dialogue going on.”

Don’t panic, we can help

Inhalerx’s second candidate IRX-616 (a) addresses panic disorder.

IRX-616 (a) contains a series of cannabinoids (CBDs) –  but not THC. Cannabinoids are purported to contain all kinds of goodness.

A discrete inhaler, this one is designed for situations such as the onset of panic on a crowded train.

Davies notes a spike in anxiety disorders post pandemic, with the average sufferer aged 24.

“There is no FDA approved drug for treating panic disorder via inhalation,” Davies says.

“This is truly a world first”.

Davies notes the company also pondered a vape formulation, but these devices are not odour free.

“There’s a lot of negative connotations about vapes and in many cases rightly so. Doctors are more familiar with a pressurised metered dose inhaler.”

The company hopes to launch a phase I study by the end of the year, enrolling healthy volunteers at Adelaide’s CMAX clinical research facility.

The trial will involve up to 24 participants across three cohorts, delivered in a single ascending dose.

Cancer trial

To be conducted across five local sites, a two-stage phase II BtCP study is targeting 156 opioid-tolerant patients for part A and 78 for part B.

About 20-40% of US cancer patients report using cannabis (much of it the repurposed recreational variety).

Davies says the botanically-derived stuff contains thousands of CBD variations.

“The challenge is having an approved medication that is consistent and works every time.”

Alternatives are confined largely to opioid (fentanyl) based nasal sprays, wafers and lozenges.

The company expects to screen the BtCP patients this month, with the first patient dosed in the first (open label titration) stage by the end of the year.

Patients who self-assess as achieving effective pain relief will go on to the double-blinded, placebo-controlled part B.

Patent position protects products

Given the inhaler and the active ingredient is standard, where lies the company’s intellectual property advantage?

“The secret sauce is the way the drug combines and how it is delivered,” says Davies.

In the case of IRX-211, the company claims protection around “the method of use and device-enabled delivery of Inhalerx’s assets”.

This includes the inhaled formulation and drug–device combination, “ensuring alignment with regulatory and clinical development programs”.

The  approach combines “patent protection, FDA regulatory exclusivity and procedural mechanisms to maintain early-market positioning.”

In the case of IRX-211, on FDA approval Inhalerx expects to qualify for three-year data exclusivity.

This prevents other applicants from relying on IRX-211’s clinical data to obtain approval for a similar inhaled dronabinol product.

The company is also extending similar coverage to future cannabinoid-based indications, “including the upcoming IRX-616 (a) program”.

So there!

Better funded than at first blush

As of the end of September, Inhalerx had cash of $170,000, having burnt $310,000 during that quarter.

But Inhalerx’s financial position is not as parlous as it looks.

In October last year the company entered a funding agreement with the Melbourne based Clendon Biotech Capital, for up to $38.5 million.

The money will cover the clinical trial costs, including associated non-clinical work over the next two to three years.

“It’s essentially a debt with options that sit underneath that,” Davies says.

Used funds are subject to capitalised interest at 15% per annum, with payment tied to trial progress.

The company has drawn down $247,000 to date.

Meanwhile the board can’t be accused of overpaying itself, as directors are paid in performance rights only.

‘Sharpen the axe’ first

To date, the FDA has approved only four cannabis-derived therapies.

For the record, they are Epidiolex (a CBD oil for epilepsy), the synthetic THC dronabinol (branded Marinol and Syndros, for nausea and anorexia) and nabilone (Cesamet, a synthetic THC for chemotherapy induced nausea and vomiting).

Of course, the drugs are used off label for other purposes.

“A lot of people have tried to get CBD medications approved,” Davies says.

“It’s an area we understand well.”

The company is confident of getting both therapies to phase II, after which it hopes to partner for phase III studies.

Given its THC-free status, the panic drug candidate would seem to have an easier path to approval.

But the winds of change are blowing, with the FDA keen to see opioid alternatives amid the White House’s war on fentanyl – and Canada.

Despite the company’s ultimate commercialisation goal backed by an “extremely supportive” FDA, Davies says the company wants to get the basics right first.

“We prefer to spend time sharpening the axe than chopping the tree.”