Daily treatment with SC0023 yielded treatment efficacy 53.5% ± 19.2% relative to baseline in 24-hour daily cough rate and 19.5% ± 6.2% placebo effect
Cough rate reduction was observed from the first day of dosing and across baseline cough rates ranging from 5 to 25 coughs/hour
Persistent cough suppression post-treatment was also observed across cough rates, reaching 86% reduction (with 95% confidence interval of 80.8% to 91.3%) relative to the 25/h baseline cough rate three weeks post treatment
Sensory Cloud Inc., a clinical-stage biopharmaceutical company pioneering therapies that deactivate mechano-sensitive ion channels to treat respiratory disease, and King Saud University, are today reporting findings from the REACH trial for the treatment of patients with refractory chronic cough (RCC). SC0023 is a proprietary therapeutic aerosol composed of ions endogenous to human airways, acting to relieve compression of mechano-sensitive ion channels implicated in chronic cough hypersensitivity.
“We are very encouraged by the REACH findings and in particular the observation of persistent treatment effect of SC0023 for several weeks post dosing,” said David A. Edwards, PhD, founder and CEO of Sensory Cloud, Inc, and adjunct professor of Medicine at Johns Hopkins Medical School. “We are still exploring the dataset and will be sharing final results in a keynote presentation at RESCON in San Francisco this fall.”
“REACH illustrates the analytical power of continuous cough monitoring,” said Kian Fan Chung, MD, Professor of Respiratory Medicine at Imperial College London and co-PI of the REACH trial with Professors Beshayr Alotaibi, MD and Kholood Altassan, PhD of King Saud University. “With over 450 patient cough count days, the REACH trial exceeded the sample size of any previous Phase 2a or 2b trial with only 10 patients, and generating intra- and inter-subject information on the time-course of treatment that, in the case of SC0023, appears vital to understanding the effects of the therapeutic.”
“REACH sheds new light on a unique modality of cough treatment, equally as first-line treatment for RCC and as a possible adjuvant for future RCC therapeutics that act downstream of the airway inflammation cascade targeted by SC0023,” said Dennis Ausiello, MD, Jackson Distinguished Professor of Clinical Medicine at Harvard Medical School, former Chief Medicine at Massachusetts General Hospital, and Chairman of the Board of Sensory Cloud Inc.
Due to a significant treatment period effect from the crossover design for the primary efficacy analysis of relative change from baseline in 24-hour cough frequency the analysis was limited to the first dosing period as a parallel arm design.
Preliminary data from the intention-to-treat (ITT) (n=10) and per protocol analyses (n=7) confirm the exploratory clinical findings of Abubakar-Waziri et al (2024) revealing reduction in cough rate over placebo in RCC patients across baseline cough rates. Post hoc analyses of the data considering adherence of the investigational product showed a 34% (n=6) placebo adjusted reduction in cough rate (p=0.045). Visual analog score (VAS) was observed to fall by 40 relative to placebo (n=6) and similarly across baseline cough rates — falling 56 for baseline cough rate of 5 coughs/hour and falling 54 for baseline cough rate of 25 coughs/hour. Persistency of cough rate suppression, as monitored using the Hyfe CoughMonitor watch, continued for several weeks post dosing notwithstanding the 3 hour clearance time of SC0023 endogenous ions as is consistent with treatment de-compression and down-regulation of mechano-sensitive ion channels (MSCs) implicated in cough hypersensitivity. There were no clinically significant treatment emergent adverse events reported, and two SAEs reported were deemed not related to the investigational product.
Sensory Cloud is preparing REACH2 with Professor Kian Fan Chung in London later this year.
