CLOUDBREAK-B (02592.HK): CBT-001 Meets Phase III Endpoints in Pterygium

NewTimeSpace News: Cloudbreak Pharma Inc. (stock code: 02592) announced topline results from the Phase 3 study of CBT-001 as a potential treatment for pterygium, with statistical significance obtained for both primary endpoints. At Month 3 for conjunctival hyperemia and at Month 12 for pterygium lesion length, both the 0.1% and 0.2% doses of CBT-001 (administered twice daily) demonstrated highly statistically significant improvements versus vehicle (p<0.001); the clinical improvement was observable as early as Week 2 and persisted throughout the 12-month follow-up cycle. The Company said this marks the first time a drug has demonstrated therapeutic effects in pterygium through a statistically significant improvement in hyperemia and lesion size.

In terms of lesion size, the benefit in the treatment group compared with vehicle was approximately 10% of the baseline value, and the observed treatment effect had not yet plateaued at Month 12. On safety, superficial punctate keratitis was the most commonly reported adverse event in the 0.1% group (20% versus 8% in the vehicle group), with most events resolving after artificial tears; other individual adverse events occurred in fewer than 10% of patients in that group, while the 0.2% dose reported similar events at a moderately higher rate.

The trial, CBT-CS301 (NCT05456425), is a multi-regional, double-masked, randomised, vehicle-controlled Phase 3 study with twice-daily dosing over 24 months and a 12-month extension for additional safety data; enrolment began in the US in June 2022 and expanded to China, New Zealand, Australia and India, with the topline summary covering 659 patients (164 on CBT-001 0.1%, 329 on 0.2% and 166 on vehicle). The Company is conducting analyses of secondary endpoints and subgroups and intends to meet the FDA on next steps for the programme. Pterygium affects just under one billion people globally, including 13 million in the US, where no drug therapy is approved. Trading in the Company's shares has been suspended since 9:00 a.m. on 10 September 2026 under an SFC order and will remain suspended until further notice.