Diurnal, the physiological hormone replacement company, today announced that it had completed enrolment of 30-healthy volunteers and begun its Phase 1 Chronocort^® study at Simbec Research located in Merthyr Tydfil (Wales, UK).

Chronocort^® is a modified release hydrocortisone formulation for the treatment of Congenital Adrenal Hyperplasia and Adrenal Insufficiency both chronic, life-long disease. Diurnal has already received two Orphan Drug designations for the above indications from the European Medicines Agency (EMA), which affords ten years of market exclusivity after the grant of marketing authorisation in Europe.

Prof Richard Ross, Chief Scientific Officer, said:

“We are delighted to have started our Chronocort^® Phase 1 study on schedule and expect to have read-out of the results during H2, 2010” .

Diurnal, the physiological hormone replacement company, today announced that it has received Medicines and Healthcare products Regulatory Agency (MHRA) and Ethics Approval to carry out an open label, randomised, single dose crossover study in healthy volunteers of its lead product Chronocort^®.

Chronocort^® is a modified release hydrocortisone formulation for the treatment of Congenital Adrenal Hyperplasia and Adrenal Insufficiency both chronic, life-long disease. The outcomes of this Phase 1 study aim to compare the pharmacokinetics of Chronocort^® to immediate release hydrocortisone and to determine the dose proportionality of Chronocort^®.

The study will be carried out at Simbec Research located in Merthyr Tydfil (Wales, UK) and is expected to start during Q2, 2010.

Prof Richard Ross, Chief Scientific Officer, said:

“It is a tremendous credit to the Diurnal and Simbec teams to have completed and achieved regulatory submission in such a short space of time. We have begun enrolment in the study which we hope to start imminently”.

Diurnal, the physiological hormone replacement company, completed a £600,000 (USD $1M; Euro €650K) investment round led by Fusion IP PLC, the university commercialisation company which turns university research into business, and Finance Wales. Both Fusion IP and Finance Wales invested £300,000 (USD $500K; Euro €325K. Diurnal will have a post money valuation of £2 million (USD $3.3M; Euro €2.2M).

Diurnal is developing novel physiological approaches to drug delivery which will help patients suffering from reduced cortisol and testosterone levels. Diurnal, headquarted in Cardiff (Wales, UK), has developed Chronocort^® a delayed and sustained release therapy to deliver hydrocortisone in a manner that mimics the body’s normal circadian rhythm (the body’s natural 24 hour hormone cycle). This therapeutic approach has the potential to help patients with deficiencies in the hormone cortisol who suffer from Congenital Adrenal Hyperplasia and Adrenal Insufficiency. These conditions require life-long treatment and Diurnal’s novel approach to drug delivery has the potential to drastically improve patients’ lives.

Working closely with Penn Pharmaceuticals (Wales, UK), a Tredegar-based pharmaceutical services company and Simbec Research located in Merthyr Tydfil (Wales, UK), Diurnal will utilise the funds raised to continue to develop its new formulation approach to endocrine therapy and to complete Phase I clinical trials of its lead product Chronocort® for adrenal insufficiency in H2 2010. The product, has already received two related Orphan Drug designations from the European Medicines Agency, which affords ten years of market exclusivity after the grant of marketing authorisation in Europe.

Martin Whitaker, General Manager at Diurnal Ltd, commented:

"Diurnal’s product pipeline has the potential to help many patients with hormone deficiencies that disrupt the body’s natural clock. Our lead compound Chronocort^® is focused on delivering a delayed and sustained release therapy. Following positive preclinical results and today’s fundraising, Chronocort^® is poised to enter Phase I clinical trials next year. In addition, it has significant market potential and has already received Orphan Drug Designation potentially giving it market exclusivity in Europe.”

David Baynes, Chief Executive Officer of Fusion IP, added:

"Diurnal’s endocrine therapies have great potential for patients suffering from hormone deficiencies. Taking Chronocort^® into phase I clinical trials next year is a major step forward for Diurnal and we are delighted to see the company making such positive progress."

Jocelyn Brown, Associate at Finance Wales, said:

“This latest funding round accelerates Diurnal’s commitment to creating niche therapeutics targeting areas of greatest unmet patient need. The continuing success of Diurnal is underpinned by their strong partners within the Welsh biosciences community, and we’re pleased to be investing in such a dynamic, forward-looking company”.

Diurnal, the physiological hormone replacement company, announced today that it has secured more than £250,000 (USD $350K; Euro €280K) in venture capital investment from Finance Wales, Fusion IP PLC and the Viking Fund.

Diurnal received the investment and an additional £200,000 (USD $280K; Euro €224K) development grant from the pharmaceutical company Pfizer to develop an endocrine (hormone) multi-platform treatment that will benefit a range of chronic illnesses.

Diurnal’s endocrine therapies have the potential to help patients with deficiencies in steroid hormones, testosterone, thyroid hormones and associated conditions. These can include regulating metabolism, growth development and puberty, tissue function and in determining mood.

Each of these deficiencies requires life-long treatment that Diurnals novel approach to drug delivery would make easier for the body to accept by mimicking its natural hormone levels.

Finance Wales is investing £150,000 (USD $210K; Euro €168K) equity alongside £50,000 (USD $70K; Euro €56K) each from the Viking Fund and university investment group, Fusion IP PLC, of which Diurnal Ltd is a subsidiary. Diurnal was originally spun out from the University of Sheffield but will be headquartered at offices in Cardiff (Wales, UK) and will work closely with Tredegar-based Penn Pharmaceuticals (Wales, UK) to develop its new formulation approach.

Martin Whitaker, General Manager at Diurnal Ltd, said:

“This funding was paramount - the investment will allow us to develop our drug development programmes to the next level and closer to final testing, licensing and commercialisation. The impact will be considerable to people who suffer from reduced cortisol and testosterone levels and by working with the body’s natural rhythm it could drastically improve their lives." J

ocelyn Brown, an Associate at Finance Wales plc, which provides commercial funding to businesses in Wales, stated:

"Diurnal Ltd is an innovative early stage pharmaceutical company that has yielded novel product opportunities through innovative research activities to commercialisation.”

"The company’s rich pipeline of product opportunities has significant market potential. Our investment, together with that of the co-investors, will support the company’s growth and development at a critical time within its life-cycle,"

David Baynes, CEO of Fusion IP, added:

"This fundraising is a great endorsement to Diurnal’s exciting science and Fusion IP is pleased to continue its support of the company through participation in this financing round."

Commenting on its investment in Diurnal Ltd, Andrew Burton, Managing Director of Viking said:

"Diurnal has identified a strong need to improve the efficiency and delivery of hormones to patients. This is a good proposition and an excellent addition to Viking’s portfolio of investments".

Diurnal Limited has announced today that it has secured the return of the clinical, commercial and intellectual property data package from Phoqus Pharmaceuticals PLC.

Diurnal was founded in 2004 as a spin-out from the University of Sheffield (Sheffield, UK) based on the research into circadian hormone rhythms by leading endocrinologist Prof Richard Ross.

Diurnal had entered into a 4-year collaboration and license agreement with Phoqus Pharmaceuticals PLC (West Malling, UK) which yielded the successful completion of three Phase 1 clinical trails and one Phase 2 clinical trial of Chronocort^® – a modified release hydrocortisone formulation for the treatment of Adrenal Insufficiency. The collaboration came to an end in July 2008 when Phoqus announced that it was to go into administration. Under the terms of the collaboration and license agreement all clinical, commercial and intellectual property data was returned to Diurnal.

Diurnal is now actively seeking partners and investors to continue with the development of the Chronocort^® programme.