First-in-class disease-modifying therapeutic aerosol targeting mechano-sensitive ion channels advances into phase 2 clinical evaluation in UK

SC Therapeutics, a clinical-stage biopharmaceutical company pioneering therapies that deactivate mechano-sensitive ion channels (MSCs) to treat respiratory and cardiovascular disease, today reports 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 [https://www.isrctn.com/ISRCTN56616986].

“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.”

About Refractory Chronic Cough

Refractory chronic cough affects millions of patients worldwide who fail to achieve adequate relief with standard treatments. The condition is characterized by cough hypersensitivity – in which the cough reflex threshold is pathologically lowered – resulting in persistent, often disabling cough that significantly impairs quality of life. Despite growing recognition of the disease burden, approved therapies remain limited and none have demonstrated disease-modifying properties. Mechano-sensitive ion channels have emerged as a promising therapeutic target given their role in transducing mechanical stimuli to drive the hypersensitive cough reflex.

About SC Therapeutics

SC Therapeutics, formerly Sensory Cloud Inc, is a clinical-stage biopharmaceutical company focused on developing first-in-class therapies that deactivate mechano-sensitive ion channels implicated in respiratory and cardiovascular disease. The Company’s proprietary platform leverages the biology of endogenous airway ions to modulate MSC activity, with the goal of achieving disease-modifying outcomes across conditions driven by aberrant mechanical signaling. SC Therapeutics is headquartered in Boston, Massachusetts.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of applicable securities laws, including statements regarding the design and objectives of the REACH2 clinical trial, the potential disease-modifying properties of SC0032, and anticipated clinical and regulatory milestones. These statements are based on current expectations and involve known and unknown risks and uncertainties. Actual results may differ materially from those expressed or implied. SC Therapeutics undertakes no obligation to update any forward-looking statements.

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