New drug CBT-009 approved to conduct Phase 1/2 clinical trial in Australia

We are pleased to announce that Australia regulatory agency has approved our application to conduct Phase 1/2 trial in Australia to evaluate safety, tolerability and pharmacodynamics of CBT-009 (atropine) on healthy volunteers. Clinical trial is scheduled to start in July 2022.

Myopia is a common visual disorder and has become the major cause of visual impairment in children and adolescents. According to statistics from the “China Eye Health White Paper”, myopia rate among Chinese adolescents ranks highest in the world. In 2018, the nationwide myopia rate among children and adolescents was 53.6%, and the prevalence rate among high school students was above 80%. According to statistics of Front & Sullivan, the number of myopia patients among Chinese children and adolescents has increased from 150 million in 2015 to 170 million in 2019, with a compound annual growth rate of 3.3%, and the patient population will continue to grow.  The number is expected to reach 190 million by 2030.

Clinical studies have shown that low-dose atropine is clinically effective in preventing myopia progression in children. Atropine is an anticholinergic receptor inhibitor that blocks the action of neurotransmitters in the central nerve system as well as the peripheral nerve system, controlling myopia progression by disabling the focusing mechanism. However, the major problem of low-dose atropine eye drops is that atropine is unstable and easily degrades in eye drops with neutral pH, which affects the commercialization of low-dose atropine eye drops. In response to this, many ophthalmic R&D companies have attempted different methods to increase the stability of atropine in eye drops, including developing special complexing agents, using deuterated water instead of water as a solvent to slow down the hydrolysis of atropine, using special eye drop equipment to drop a small amount of slightly acidic stable preparation to reduce irritation, or using a closed-circuit solid atropine and liquid separation device to overcome the stability problem of low concentration atropine in aqueous solution. Cloudbreak Pharma developed the first non-aqueous atropine eye drop product (CBT-009) to eliminate the degradation of atropine in eye drops, thereby improving the stability of the drug.

CBT-009 is our fourth asset in the clinical stage along with CBT-001 for pterygium, and CBT-006 for meibomian gland dysfunction associated dry eye disease.  The encouraging progress of CBT-009 has once again broaden Cloudbreak Pharma’s product pipeline to becoming a leading ophthalmic R&D company.