Welcome to InhaleRx Ltd
InhaleRx Ltd (IRX) is an Australian biotechnology company focused on the development of precision medicine delivered via inhalation.
Leaders in the development of innovative inhaled therapeutics to address unmet medical needs for the benefit of the global health care market.
Targeting acute symptoms that patients experience in two therapeutic areas, Mental Health, and Pain, the company is pursuing New Drug Approvals (NDA’s) with the Food & Drug Administration (FDA).
World-first rapid onset treatments for carefully chosen acute conditions with a large total addressable market.
Why Inhaled therapies?
There are many treatment options available to patients that suffer from chronic conditions, but there’s very few safe and effective options that target acute episodes.
Acute treatment options can be used as an adjunct to chronic therapies, or in some cases may replace the need for use of medications to manage symptoms.
- Application of treatment and Mechanism of Action
- Inhaled
- Oral
- Transdermal
- Injectable
- Onset of Action^
- Fast
- Slow
- Slow
- Fast
- Offset of Action^
- Fast
- Slow
- Slow
- Fast
- Bioavailability
- Fast
- Low
- Low
- High
- Not impacted by 1st pass metabolism
- Ease of patient use
- Suitable for Acute Indications
Magnitude of Opportunity
Pain Management Market
The pain management market is estimated to be worth $75 billion (USD) in 2023, with a CAGR 3.6% between 2023 and 2028*.
$75
Billion (USD)
IN 2023
3.6%
CAGR
- Inhaled analgesic therapies outside of a clinical setting are uncommon.
- Nasal formulations of fentanyl (e.g. Lazanda) have shown to be efficacious, however these were withdrawn due to safety concerns.
- Sublingual fentanyl products (e.g. Actiq, and Fentora) remain as the main treatment options for intense breakthrough pain. Abstral has also been withdrawn in the US.
Magnitude of Opportunity
Mental Health
The global anxiety disorder treatment market is projected to reach USD 9 billion by 2030 at 2.9% CAGR during the forecast period 2022-2030. It includes panic disorders, post-traumatic stress disorder (PTSD), phobias, and obsessive-compulsive disorder.
- Panic Disorder is estimated to affect approximately 3-5% of the general population.
- More prevalent in women and typically begins in young adulthood. The exact prevalence of panic disorder is difficult to determine, as it is often under-diagnosed and under-treated.
GLOBAL ANXIETY DISORDER TREATMENT MARKET
$9
Billion (USD) BY 2023
Strategic Objectives
Short Term
Market Testing
- Acquire distribution experience in the Australian setting.
- Acquire valuable insights over 18 months of data from over 10,000 Australian patients and physicians to better understand the product market fit and the role of novel inhalation devices.
- Acquire Schedule 4, 8 wholesale / supply scheduled medications from the Department of Health.
- Acquire Import and Export licences from the Office of Drug Control (ODC).
Medium Term
New Product Development
- Work with best in class global experts for formulation configuration drug / device development plans.
- Source FDA compliant GMP and ISO13485 components for assembly.
- Test plume geometry and delivery efficiency.
- Commence a stability program.
Long Term
Commercialisation Following Clinical Trials
- Execute two drug development pipelines in parallel, both targeting an NDA via the streamlined regulatory pathway, FDA 505(b)(2) to develop the first ever FDA medically registered inhaled cannabinoid delivery systems.
- Acquire Approved Investigational New Drug (IND’s) on each drug candidate.
Assets Under Development
Pain Asset – IRX 211
Mental Health Asset – IRX616
Why the 505(b)(2) over standard New Drug Approval (NDA) pathway?
Standard Drug Development Pathway (FDA)
FDA 505(B)(2)PATHWAY TO REGISTRATION
Leveraging existing data reduces risk and cost
Time to approval – only 3 to 4.5 years (compared to the usual 10+ years)
Regulatory Strategy
Faster approval process
Enabling access to use data from previously conducted studies of approved drugs can result in a faster approval process as the FDA.
Cost savings
There are often significant cost-saving opportunities as companies can leverage previously conducted studies of approved drugs, which can reduce the costs associated without executing a full drug-development program.
Reduced regulatory burden
The FDA may not require a full complement of preclinical and clinical studies.
Increased flexibility
The 505(b)(2) pathway provides opportunities to incrementally innovate on already approved drugs.
