SC Therapeutics, a clinical-stage biopharmaceutical company pioneering therapies that deactivate mechano-sensitive ion channels (MSCs) to treat respiratory and cardiovascular disease, recently reported initiation of the REACH2 trial. The study will evaluate the Company’s lead product candidate in patients with refractory chronic cough (RCC) – a debilitating condition for which no disease-modifying treatment options currently exist. The trial will be run in three major cough centers across the UK.
A Novel, Disease-Modifying Mechanism of Action
SC0032, SC Therapeutics’ most advanced product candidate, is a proprietary therapeutic aerosol composed entirely of ions endogenous to human airways. Unlike current symptomatic investigational drugs – including P2X3 receptor antagonists and neurokinin-1 (NK1) receptor antagonists that seek to dampen neural hypersensitivity through receptor blockade – SC0032’s approach directly addresses the upstream inflammatory drivers of chronic cough. By acting to relieve compression of MSCs implicated in chronic cough hypersensitivity, the product candidate targets the pathophysiological airway root cause of disease rather than its downstream manifestations.
This mechanistic distinction positions SC0032 as potentially disease-modifying. Because the therapeutic effect is directed at normalizing aberrant MSC activity rather than transiently suppressing cough reflex signaling, the Company believes treatment may produce durable benefit that persists beyond the active dosing period – a hallmark feature that differentiates it from existing symptomatic approaches.
REACH2 Trial Design
REACH2 is a randomized, placebo-controlled study designed to explore the effects of the product candidate over a three-week treatment period in patients with RCC. Consistent with the Company’s disease-modifying mechanistic hypothesis, the protocol includes a four-week post-treatment follow-up period after cessation of dosing. This follow-up phase is specifically designed to characterize whether therapeutic benefit is sustained beyond treatment, providing a critical early test of durability of effect and further distinguishing the product candidate from symptomatic alternatives. The trial will utilize Hyfe’s CoughMonitor Suite for continuous objective cough counting.
A central design consideration in REACH2 is the recognition of substantial day-to-day variability in cough frequency – a well-documented challenge in RCC clinical research that can obscure true treatment effects and complicate trial interpretation. To address this, the trial’s primary efficacy endpoint will compare seven continuous days of objective cough monitoring at the end of the baseline period with seven continuous days of monitoring at the end of the treatment period.
The Company believes this extended continuous monitoring approach will meaningfully reduce the influence of day-to-day variability, thereby improving the robustness and interpretability of the efficacy assessment relative to shorter or less continuous measurement windows. The study is being conducted at Royal Brompton Hospital, King’s College Hospital, and Belfast City Hospital
“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.”
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