Highlights:
- Secured Funding: InhaleRx has secured a funding facility of up to $38.5 million from Clendon Biotech Capital to fully cover the clinical trial costs, including the associated non-clinical work and trial drug manufacturing costs for the IRX-211 and IRX-616a drug development plans through to the completion of Phase 2 clinical trials.
- Clinical Progress: This funding will enable InhaleRx to move forward with its clinical development plans for IRX211 and IRX616a, including non-clinical data. It will also enable IRX to address the requirements of the US Food & Drug Administration (‘FDA’) relevant to its recent IRX-616a Investigational New Drug (‘IND’) application.
- Focus on Transformational Therapeutics: With this strategic support, InhaleRx is well positioned to accelerate the development of breakthrough inhaled therapies for patients with unmet medical needs.
The funding agreement provides InhaleRx access to up to $38.5 million in funding, which is expected to allow the Company to reach the Phase 3 pivotal stage for both IRX-211 and IRX-616a within the next 2-3 years. The facility allows for the drawdown of funding as eligible expenditure is incurred.
Further details of the Clendon Biotech facility and options included within the proposed funding structure are included in Appendices 1 and 2.
Once approved, the Clendon Biotech Capital facility will allow the Company to immediately activate the specification adjustment and batch manufacturing work required in the manufacture of the requisite trial drugs for the proposed IRX616a (Phase 1), and IRX-211 (Phase 2) trials.
This partnership ensures that InhaleRx can move forward with the next stages of its clinical trials and non- clinical work, including addressing the further requirements outlined in FDA feedback related to its recent IND submission for IRX-616a.
While it is expected that this funding arrangement will cover all necessary clinical trial costs, InhaleRx will remain responsible for covering its operational and corporate overheads as these costs are specifically outside the scope of the funding arrangement. The Company remains confident in its ability to secure the necessary additional funding to meet these working capital costs and ensure continued operational sustainability.
About Clendon Biotech Capital
Clendon Biotech Capital is a Melbourne based venture capital investor which is keenly focused on small to mid-size bio-technology companies in its target therapeutic areas - neuroscience, gastroenterology, oncology and anti-aging.
The Board of InhaleRx views the partnership with Clendon Biotech Capital as a transformative step in securing the Company’s ability to execute its clinical development strategy, which will further position it as a leader in the inhaled therapeutics sector.
IRX’s CEO, Mr. Darryl Davies, said: "We are very excited to have Clendon Biotech Capital as a committed funding partner. This agreement enables InhaleRx to focus on advancing our key clinical programs, including addressing the requirements outlined in FDA feedback on our recent IRX616a IND application. While this partnership provides vital support for our clinical development program, we will continue to explore opportunities to fund our broader operational needs and ensure the long-term success of the Company."
The Drug Development Pathway for IRX-211
IRX-211 is a drug-device medication, specifically designed to target breakthrough cancer pain (‘BTcP’), a condition characterised by sudden, intense episodes of pain that occur despite otherwise controlled cancer related chronic pain.
IRX-211 delivers a precise dose of the medication designed to provide rapid onset relief, ensuring quick absorption and action when needed most.
BTcP can be particularly debilitating for cancer patients, and conventional treatments often fall short due to delayed onset of action or suboptimal dosing. IRX-211 aims to address this gap by providing fast, effective relief, leading to an improvement in the quality of life of individuals suffering with cancer-related pain. By offering a more targeted and efficient solution, IRX-211 expects to become a cornerstone in the pain management toolkit for cancer patients, enhancing their overall comfort and care.
With the Phase 1 clinical trial complete, the next stage for IRX-211 is to commence the planned Phase 2 Double-blind, Placebo-controlled, Multicenter, Cross-over Study with Titration Period to Evaluate the Efficacy and Safety of IRX211a for the Treatment of Breakthrough Cancer Pain (‘BTcP’) in opioid tolerant patients in order to assess safety and efficacy of IRX-211.
The trial has been strategically designed to mirror the registration trials used for the fentanyl products, which are the only FDA approved drugs for treating BTcP.
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Figure one: Individual patient (001-005) and pooled results highlighting improvements in fibromyalgia domains as presented by University of Michigan 9 August 2024 (adapted)
Figure two: Individual patient and pooled results as presented by University of Michigan 9 August 2024 (adapted)