UPDATE: Diurnal Prepares For First Revenue As Appoints Trial Partner

LONDON (Alliance News) - Pharmaceutical firm Diurnal Group PLC on Monday appointed a clinical trial services provider for its Chronocort treatment, as it posted a widened interim loss due to increased research and administrative costs.

For the six months ended December, pretax loss widened to GBP7.8 million from GBP5.7 million the year prior. This was after research and development costs and other administrative expenses rose in the period to a combined GBP7.7 million from GBP5.7 million. Diurnal generated no revenue in either years.

"Since our last results announcement, the company has made significant steps towards becoming a revenue-generating specialty pharma company focused on endocrinology," Diurnal Chief Executive Officer Martin Whitaker said. "The approval of our first product, Alkindi, in Europe in early 2018 highlights the company's ability to take a product from concept through to commercialisation, with market launch planned in Q2 2018."

Diurnal said it will generate its first revenue in 2018.

"We are also pleased to complete patient recruitment in the European Chronocort Phase III study, with data expected later in 2018," Whitaker added. "Our experience in the development, registration and preparation for launch of Alkindi will be invaluable in the progression of Chronocort towards potential approval and launch in 2020. This positive momentum is also reflected in our US programmes; we have made significant progress with the development of Alkindi and Chronocort for this important market, with activities to support the planned Alkindi Phase III regulatory package ongoing and Chronocort Phase III development expected to commence later in 2018."

Separately, Diurnal also said it has appointed contract research firm Worldwide Clinical Trials as its preferred clinical trial services partner. Worldwide Clinical will initially support Diurnal in the US clinical development of Chronocort.

No financial details of the contract were disclosed.

Diurnal anticipates the Phase III Chronocort study for the treatment of congenital adrenal hyperplasia to begin in the middle of 2018. The trial will recruit up to 150 patients and last for 12 months.

In addition, Worldwide Clinical will assist in Diurnal's Phase II proof-of-concept trial in adrenal insufficiency. This is expected to commence around the end of 2018.

"With its extensive experience in planning and recruiting studies in rare and orphan diseases, Worldwide is the ideal partner to support the US clinical development of Chronocort for the treatment of congenital adrenal hyperplasia and adrenal insufficiency," Whitaker said. "The US represents an estimated total market opportunity of approximately USD1 billion for Chronocort in these two disorders. We are looking forward to working with Worldwide as we commence the Phase III registration package in mid-2018."

Shares in Diurnal were 1.9% higher at 215.00 pence on Monday.