Boston, Mass. — SC Therapeutics has initiated a Phase 2 clinical trial evaluating its lead therapeutic candidate, SC0032, in patients with refractory chronic cough, the clinical-stage biopharmaceutical company said.
The randomized, placebo-controlled REACH2 trial will enroll patients at three major cough centers in the United Kingdom: Royal Brompton Hospital, King’s College Hospital and Belfast City Hospital.
SC0032 is a proprietary therapeutic aerosol composed entirely of ions naturally found in human airways. The treatment is designed to deactivate mechano-sensitive ion channels implicated in chronic cough hypersensitivity.
Unlike investigational treatments such as P2X3 receptor antagonists and neurokinin-1 receptor antagonists, which seek to reduce neural hypersensitivity by blocking receptors, SC0032 is intended to address upstream inflammatory factors associated with chronic cough.
By relieving compression of mechano-sensitive ion channels, SC Therapeutics said the therapy may target the underlying airway dysfunction rather than temporarily suppressing cough reflex signaling. The company believes this mechanism could produce benefits that continue after treatment ends.
The REACH2 trial will evaluate SC0032 over a three-week treatment period, followed by four weeks of post-treatment monitoring. The follow-up period will assess whether any therapeutic benefits persist after dosing has stopped.
The study will use Hyfe’s CoughMonitor Suite to continuously and objectively measure cough frequency.
To account for the substantial day-to-day variation in cough frequency among patients, the trial’s primary efficacy endpoint will compare seven consecutive days of monitoring at the end of the baseline period with seven consecutive days at the end of treatment.
SC Therapeutics said the extended monitoring periods are intended to reduce the effect of daily fluctuations and provide a more reliable assessment of the treatment’s efficacy.
“We are excited by REACH2 and the opportunity it brings to clarify preliminary RCC treatment findings from REACH1, including the rapid reduction of cough and cough bout frequency and the more gradual reduction in cough hypersensitivity we anticipate to occur with the down-regulation of MSCs implicated in hypersensitivity,” said David A. Edwards, scientific founder and CEO of SC Therapeutics. “What we learn from SC0032 will be helpful in understanding treatment possibilities for many respiratory and cardiovascular conditions associated with dehydrated airway mucosa, including all etiologies of chronic cough.”
Refractory chronic cough affects patients who do not receive adequate relief from standard treatments. The condition is associated with cough hypersensitivity, in which the threshold for triggering the cough reflex is abnormally low, resulting in a persistent and potentially disabling cough.
Approved treatment options remain limited, and SC Therapeutics said no available therapy has demonstrated disease-modifying properties.
