Melbourne-based healthcare innovator InhaleRx Limited (ASX: IRX) has secured a substantial funding deal worth up to AUD 38.5 million, aiming to revolutionize the treatment of pain management and mental health disorders. The deal, inked with Clendon Biotech Capital, is set to fund the clinical development of two of InhaleRx’s breakthrough drug-device products, IRX-211 and IRX-616a, through to Phase 2 clinical trials.

The substantial funding allows InhaleRx to make significant strides in addressing unmet medical needs within the pain management and mental health spheres. This partnership is designed to propel two innovative therapeutics, IRX-211, aimed at breakthrough cancer pain, and IRX-616a, targeted at panic disorder, towards later-stage clinical trials without financial delays.

Paving the Way for Clinical Advancements

The new financial backing will allow InhaleRx to cover all costs related to the Phase 1 and 2 clinical trials, including drug manufacturing and regulatory requirements. According to InhaleRx’s CEO, Darryl Davies, this financial boost will enable the company to focus on advancing their key clinical programs while also meeting the rigorous requirements laid out by the U.S. Food and Drug Administration (FDA). Davies noted that the funding removes a major obstacle in moving the clinical development forward.

Clendon Biotech Capital’s commitment means that InhaleRx can now activate the necessary batch manufacturing work for its upcoming Phase 1 and Phase 2 trials. Moreover, this will allow the company to meet FDA feedback requirements for its recent Investigational New Drug (IND) application for IRX-616a.

Breakthrough Products: IRX-211 and IRX-616a

IRX-211 aims to address a significant gap in cancer treatment, specifically in managing breakthrough cancer pain (BTcP). This condition is marked by sudden, intense episodes of pain that occur despite ongoing treatment for chronic pain. IRX-211 is designed to provide rapid-onset relief, ensuring cancer patients receive prompt care when they need it most.

The other spotlight product, IRX-616a, is designed to bring fast and effective relief to patients suffering from panic disorder. The medication is delivered via a specialized inhalation device that ensures rapid onset, which is crucial during sudden panic attacks when typical treatments might be too slow or cumbersome. The company expects that IRX-616a could be transformative for individuals experiencing acute anxiety episodes, helping them regain a sense of control more swiftly.

Funding Terms: What This Means for InhaleRx

The deal with Clendon Biotech Capital provides InhaleRx access to a funding facility up to AUD 38.5 million, with structured drawdowns aligned to clinical project milestones. The partnership involves a 15% per annum interest rate, with repayment timelines linked to project completion milestones. In addition, Clendon Biotech Capital will receive options in InhaleRx representing nearly 19.9% of the ordinary shares, strengthening its vested interest in the success of the ongoing research.

With a focus on neuroscience, oncology, and mental health, Clendon Biotech Capital is well aligned with InhaleRx’s therapeutic goals. InhaleRx’s board has touted this partnership as a “transformative step” that will facilitate the company’s aspirations to lead the inhaled therapeutics market.

Next Steps and Market Prospects

Looking ahead, InhaleRx plans to kick off its tender process for selecting a Clinical Research Organization (CRO) to oversee upcoming Phase 1 studies for IRX-616a. This will involve assessing pharmacokinetics, safety, and tolerability in healthy adult volunteers. Upon successful completion, InhaleRx aims to reapply for Human Research Ethics Committee (HREC) approval to move forward with the Phase 2 trials.

For IRX-211, the planned Phase 2 clinical trial is expected to evaluate its safety and efficacy in cancer patients experiencing breakthrough pain, with design elements that strategically mirror existing FDA-approved therapies.

Aiming for FDA Approval and Beyond

InhaleRx remains committed to pursuing an expedited regulatory pathway via the FDA’s 505(b)(2) process. The company’s ultimate aim is to secure New Drug Approval (NDA) status for both IRX-211 and IRX-616a by the end of 2027, at which point they will likely commence pivotal Phase 3 trials. With the funding from Clendon Biotech Capital, InhaleRx believes it can advance both products to the critical next stages without compromising financial stability.

InhaleRx’s entry into the advanced stages of clinical trials for inhaled therapies is expected to bolster its share value, which recently saw an uptick following the funding announcement. Market watchers have responded positively, anticipating that these groundbreaking treatments could substantially expand the company’s revenue potential if successful.

The future looks promising for InhaleRx as it continues its mission to improve outcomes for patients in the areas of pain management and mental health. With robust financial backing and a clear strategic roadmap, the company stands poised to take a leading position in the competitive landscape of inhaled therapeutics.

  ASX, Clendon Biotech Capital, Darryl Davies, FDA, InhaleRx Limited, IRX-211, IRX-616a, Melbourne, Phase 1