SoftOx Solutions AS (SOFTOX-ME.OL) on Monday announced that the Danish Medicines Agency, or DMA, has approved the company's clinical trial application for a combined Phase 2a dose-escalation and proof-of-concept study of its SoftOx Inhalation Solution.
The integrated study design represents a pivotal milestone in SoftOx's clinical program and marks the first human efficacy-oriented assessment of SoftOx Inhalation Solution (SIS) in a target patient population.
Following the announcement, SOFTX.OL are trading 35.74% higher at 0.0828 Norwegian Kroner in the OSLO market.
SIS targets biofilm-associated infections through a patented, non-antibiotic mechanism designed to avoid resistance.
The proposed Phase 2a trial includes a dose-escalation study in healthy volunteers, designed to confirm safety and tolerability at increasing dose levels and a proof-of-concept study in people with cystic fibrosis. It will also assess safety at higher doses and generate key data on bacterial load reduction in the CF airway environment.
The upcoming key milestones of the study comprise the dose-escalation topline data, which is a key validation point for initiating PoC testing, and is expected in the first half of 2026. The final Phase 2a proof-of-concept readout is expected in the first quarter of 2027.
In cystic fibrosis alone, more than 13,000 patients across the US, Germany, France, Italy, Spain (EU4) and the UK rely on chronic inhaled antibiotic therapy that drives a market opportunity that exceeds $600 million every year.
Notably, the mechanism of SIS is also relevant to non-CF bronchiectasis, a significantly larger indication affecting approximately 445,000 patients with a potential market opportunity exceeding $5 billion.
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