US-based biopharmaceutical firm Spyryx Biosciences has started patient enrolment in a Phase II clinical trial (HOPE-1) of its investigational candidate SPX-101 to treat cystic fibrosis (CF).
SPX-101 is a therapeutic peptide being developed to target epithelial sodium channels (ENaC) on the surface of the airway to reduce channel density by cellular internalisation.
Designed to improve airway and mucus hydration, SPX-101 also promotes mucociliary clearance.
The randomised, double-blind, placebo-controlled Phase II HOPE-1 trial will assess the safety and efficacy of various dose levels of SPX-101 inhalation solution over 28 days in around 78 subjects.
Being conducted in Canada, the UK, France and Portugal, the trial will include two serial patient cohorts.
Spyryx Biosciences chief medical officer Alistair Wheeler said: “This study will provide data relating to efficacy and safety at the earliest opportunity.
“We are particularly proud that patients who were part of the protocol review process have provided positive feedback, reflecting that we have kept the investment of their valuable time to a minimum.”
The firm reported favourable data from a Phase I clinical trial conducted to investigate the safety, tolerability, and pharmacokinetics of single ascending and multiple ascending doses of SPX-101 in 64 participants.
According to the results, SPX-101 was well-tolerated without any dose-limiting safety findings such as adverse effects on lung function and shifts in serum or urinary electrolytes.
Furthermore, the investigational candidate was observed to have low systemic exposure and rapid clearance from the circulation.