Opthea Ltd (ASX:OPT) (FRA:UKJ) (OTCMKTS:CKDXY), a Victorian company focused on commercialising eye therapeutics, plans to enrol and dose patients in two Phase 2-stage clinical trials in the next 12 months.
The South Yarra-based company, which is appearing at the upcoming ASX Small and Mid-Cap Conference in Sydney on Thursday next week, used its 2017-18 annual report to outline its agenda for the upcoming financial year.
Opthea increased its annual revenues by 95% to $1.2 million during the 2017-18 financial year, on the back of a $16.9 million loss from ordinary activities which were attributable to members.
The company’s losses increased 172.9% as it continued to progress a clinical trials program currently at the Phase 2 stage.
Net tangible assets per share came in at 19 cents, compared to 27 cents in the 2016-17 financial year.
Opthea chairman and investor Geoffrey Kempler told fellow shareholders it had been a strong year for the company on the operations front.
Kempler wrote in an overview to the company’s annual report issued today: “We moved forward with our clinical strategy to investigate our lead drug candidate OPT-302 in two retinal eye diseases, wet age-related macular degeneration and diabetic macular edema.
“With two clinical trials currently ongoing, a Phase 2b study of 351 patients with wet AMD and a 117 patient Phase 1b/2a clinical trial in DME, the company remains focused on advancing OPT-302 through clinical development and addressing the unmet medical need that remains for patients with these diseases.”
Opthea managing director and CEO Dr Megan Baldwin — who will speak at the inaugural ASX conference in Darling Harbour next week — issued a directors’ report on behalf of the company board, which outlined a vision for the next 12 months.
Opthea’s annual report said it was on track to progress its clinical development program for its therapeutic OPT-302 and meet milestones as it investigated the therapy in people with diabetes — those with diabetic macular edema (DME) — and elderly people with wet age-related macular degeneration (AMD) by the year 2020.
The company directors reported that in the next 12 months Opthea planned to complete patient enrolment for its Phase 2b wet AMD trial and complete the first six-monthly dosing regimen for the elderly patients.
Wet AMD is the leading cause of blindness in people aged older than 55 years and leads to loss of vision in what is known as the central visual field.
Opthea expects it will share primary data analysis for the wet AMD Phase 2b by early 2020.
The company raised $45 million to progress the trial in April last year.
Opthea also plans to finish recruiting and dosing patients in its 351-patient Phase 1b/2a clinical trial in DME in the next year.
DME is the leading complication for people with diabetes and is also the main cause of blindness in diabetics.
The company also intends to report the outcomes of a Phase 1/2a study of OPT-302 in wet AMD patients in a peer-reviewed journal.
Opthea vision for the coming year also includes consulting ophthalmology opinion leaders about its clinical program to ensure its well designed and executed.