Diurnal Group plc announced that the first patient has been dosed in its Phase 3 pivotal clinical trial ofhydrocortisone modified-release hard capsules (DNL-0200 -approved in Europe and the UK under the commercial name Efmody®)for adults with congenital adrenal hyperplasia (CAH). The pivotal Phase 3 randomised, double-blind, active-controlled, clinical trial, known as CONnECT, is evaluating the efficacy, safety and tolerability ofmodified-release hydrocortisonecompared with immediate-release hydrocortisone replacement therapy in participants aged 16-years and over with CAH. The pivotal studyfor key US and Japan marketsworth together in excess of $100m per annum will recruit up to 150 subjects with CAH who will be treated for a period of 52 weeks in centres across Japan, the US, France, and Turkey.

The study is anticipated to take up to one year to recruit all patients, with subsequent data readout anticipated in 2024. The study is being conducted under a Special Protocol Assessment (SPA) that has been agreed with the US FDA. The SPA provides agreement that the Phase 3 trial design adequately addresses objectives that would support the regulatory submission for drug approval.

DNL-0200 is a preparation of hydrocortisone that has been specifically designed for patients with diseases of cortisol deficiency such as CAH and is currently approved as the only near physiological cortisol replacement treatment for CAH in Europe and the UK.