InhaleRx Limited has introduced SRX-25, an oral fixed-dose combination therapy targeting Treatment-Resistant Depression, aiming to improve patient access and adherence. The company also secured $1 million in capital to advance clinical development and plans a strategic rebrand.
- Launch of SRX-25 oral Esketamine and CYP450 inhibitor combo for Treatment-Resistant Depression
- Development via FDA 505(b)(2) pathway with planned Phase 1 and Phase 2 trials
- Secured $750,000 placement and $250,000 rights issue to fund development
- Backing from Linlithgow Family Office with $12.6 million funding commitment
- Proposed rebranding to Nexalis Therapeutics Limited to reflect expanded drug pipeline
A New Chapter in Depression Therapy
InhaleRx Limited, an Australian clinical-stage drug developer, has announced a significant expansion of its mental health portfolio with the addition of SRX-25, an oral fixed-dose combination therapy designed to treat Treatment-Resistant Depression (TRD). This new asset combines Esketamine, a rapid-acting antidepressant, with a CYP450 inhibitor that enhances drug bioavailability, potentially overcoming the limitations of current intranasal Esketamine treatments.
Esketamine, marketed as Spravato by Johnson & Johnson, has proven efficacy but requires administration in clinical settings due to its intranasal delivery method. This restricts patient access and adherence, creating a substantial unmet need in the TRD market, which was valued at nearly $2 billion globally in 2023 and is expected to more than double by 2030.
Strategic Development and Funding
SRX-25’s oral formulation aims to offer a more convenient and scalable treatment option, potentially broadening patient reach and improving adherence without sacrificing the rapid antidepressant effects of Esketamine. InhaleRx plans to advance SRX-25 through the US FDA’s 505(b)(2) regulatory pathway, leveraging existing safety data to accelerate development and reduce costs.
The clinical development roadmap includes a Phase 1 pharmacokinetic study followed by a Phase 2 proof-of-concept trial, targeting readiness for Phase 3 within two to three years. This timeline is supported by a $12.6 million funding commitment from the Linlithgow Family Office, which also holds options aligned with clinical milestones.
Capital Raising and Corporate Evolution
To support SRX-25’s development, InhaleRx completed a $750,000 placement at 2.5 cents per share and plans a non-renounceable rights issue to raise an additional $250,000. These capital raises will fund non-clinical work and working capital needs. Peak Asset Management acted as lead manager for these offers.
Reflecting its broadened focus beyond inhaled therapies, the company proposes a rebrand to Nexalis Therapeutics Limited, subject to shareholder approval. This repositioning signals a strategic shift towards becoming a diversified drug development company with a strong emphasis on mental health.
Looking Ahead
SRX-25 represents a potentially transformative step in addressing the challenges of TRD treatment by combining proven compounds into a patient-friendly oral therapy. If successful, it could disrupt the current market dominated by intranasal Esketamine and open new pathways for patient care and commercial partnerships.
Bottom Line?
InhaleRx’s SRX-25 could redefine depression treatment accessibility, but clinical and regulatory hurdles remain ahead.
Questions in the middle?
- How will SRX-25’s undisclosed CYP450 inhibitor differentiate it from existing therapies?
- What are the detailed timelines and endpoints for the upcoming clinical trials?
- How will the proposed rebranding impact investor perception and market positioning?