StockMarketWire.com - Diurnal Group has announced positive data from the food matrix compatibility study for Alkindi (development programme name: Infacort; hydrocortisone granules in capsules for opening) in healthy adult volunteers.

It said this study supports the planned US registration package for Alkindi for the treatment of paediatric adrenal insufficiency (AI).

The company has opened an investigational new drug application for Alkindi and, following advice from the US Food and Drug Administration, will be in a position to start the next study in the registration programme, a bioequivalence study in healthy adult volunteers, during H1 2018.

The food matrix compatibility study was a single centre, open‑label, randomised, single dose crossover study in 18 healthy adult subjects (EudraCT NUMBER: 2016-001388-36; ClinicalTrials.gov Identifier: NCT03178214).

The primary objective of the study was to evaluate the bioavailability of Alkindi multi-particulate granules administered as sprinkles onto soft food or yoghurt compared with direct administration to the back of the mouth.

The secondary objective was to assess the safety and tolerability of Alkindi throughout the study. Diurnal said the results of the study confirmed that the pharmacokinetics of Alkindi when sprinkled on to soft food or yoghurt were equivalent to Alkindi administered directly. There were no adverse events and Alkindi was well tolerated.

The group also issued a trading update and said it was in a strong financial position with cash and cash equivalents and held-to-maturity financial assets (unaudited) of £14.0m at the end of 2017 (31 Dec 2016: £25.6m).

Chief executive Martin Whitaker said: 'We are delighted to have ended a very productive 2017, with our first product, Alkindi, receiving a positive opinion from the EMA.

'This positive momentum continues into 2018 as we expect to receive the formal Marketing Authorisation from the European Commission in February, followed by our first European launch of this product with our own salesforce in the second quarter of 2018.'




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