Diurnal and IP Group eye 2017 launch for childhood hormonal treatment

11th Jul 2016 08:00

(ShareCast News) - Diurnal Group, 45%-owned by university spin-out specialist IP Group, has produced positive clinical trial results for its treatment for a rare hormonal disease in young children.A European Phase III study for AIM-quoted Diurnal's Infacort treatment for paediatric Adrenal Insufficiency (AI) met its primary target by demonstrating a dose of Infacort produced a statistically significant increase in cortisol, an essential hormone that is lacking in AI sufferers.Sheffield-based Diurnal, which was a 2004 spin-out from the local university thanks to investment from FTSE 250-listed IP, found no serious adverse events and is now carrying out a full evaluation of the data before it is expected to publish results of this comprehensive analysis later this quarter.AI, which is caused by primary adrenal failure or hypopituitarism, or Congenital Adrenal Hyperplasia (CAH), has been identified as a rare disease in Europe where there are estimated to be approximately 4,000 sufferers under the age of six, with no current licensed hydrocortisone preparations approved in the region specifically designed to treat these young patients.Diurnal chief executive Martin Whitaker said the initial results were "very exciting" as Infacort has "the potential to address a significant unmet need for children with AI who are not being treated satisfactorily".He added: "This marks a significant developmental milestone for Diurnal as we move towards building a proprietary endocrinology franchise based on Infacort and our second product, Chronocort, which is in Phase III trials in Europe for adult CAH."With Infacort now ready for regulatory filing later this year and anticipated market authorisation in late 2017, we have taken a major step towards realisation of our vision."Following US Food and Drug Administration (FDA) feedback, Diurnal said it will begin the US registration programme for Infacort in 2016.IP biotech chief Sam Williams said: "This is an important milestone in Diurnal's development and validates our decision to back the company from inception in 2004 all the way to late-stage clinical studies and market authorisation, which the Company now expects in 2017."He pointed out that Diurnal achieved the milestone several months ahead of schedule, which he said demonstrated its management's ability to continually meet or exceed expectations.Diurnal is expected to release pivotal data in early 2018 for its second Phase III product, Chronocort."IP Group's significant holding in Diurnal reflects our desire to back a focussed portfolio of high-conviction biotech companies."