PQS Phoqus

RNS Number:9831G
Phoqus Pharmaceuticals PLC
05 November 2007


                     ChronocortTM clinical programme update

West Malling, UK, 5 November 2007: Phoqus Pharmaceuticals plc (AIM: PQS) 
("Phoqus Pharmaceuticals" or the "Company"), the speciality pharmaceutical
company, today announces an update on the progress and design of the clinical
trial programme for ChronocortTM, its novel product in development for the
treatment of patients with congenital adrenal hyperplasia (CAH) and acquired
adrenal insufficiency (AI).

ChronocortTM is currently undergoing a Phase II clinical trial (Study #004) in
patients with CAH that is being conducted at the US National Institutes of
Health (NIH). The open-label trial in 12 CAH patients, which commenced at the
beginning of September, is progressing well, with 6 patients already enrolled
and on treatment with ChronocortTM and the remaining patients identified by the
NIH. The Company now expects to release the results of Study #004 during the
first quarter of 2008. Detailed planning is currently underway for the proposed
pivotal Phase III clinical trial in CAH which the Company now expects to
commence during the first half of 2008, subject to further consultation with the
FDA. The Company is planning for the potential launch of ChronocortTM in its
lead indication of CAH during the last quarter of 2009/early 2010.

Separately, under the protocol assistance available due to ChronocortTM's orphan
drug designation, Phoqus Pharmaceuticals has received regulatory feedback from
the EMEA over the design of clinical trials in ChronocortTM's second indication,
AI. The guidance from the EMEA enables a more straightforward pivotal clinical
trial design than had originally been anticipated, with agreement to utilise a
pharmacokinetic primary endpoint instead of quality of life (QOL). This has the
potential to reduce the risk of the pivotal trial as the Company has already
demonstrated that ChronocortTM can achieve the required pharmacokinetic profile
in healthy volunteers. As a result of the feedback, Phoqus Pharmaceuticals plans
to undertake a small Phase II study in patients with AI prior to commencing a
pivotal Phase III trial. Further updates regarding the proposed AI clinical
programme design and anticipated timings will be provided by the Company in due
course.

Phoqus Pharmaceuticals' CEO, Dr Richard Mason, commented:

"We are pleased with the progress of Study #004 and look forward to completing
the trial and releasing the results in due course.  Chronocort has the potential
to provide real clinical benefit to patients with congenital adrenal hyperplasia
and Study #004 should provide us with the first evidence of this."

"With respect to Chronocort's second indication of acquired adrenal
insufficiency, the guidance received from the EMEA on the design of the clinical
trials has been extremely helpful and provides for a simpler and lower risk
clinical trial programme than we had originally envisaged."


Enquiries:

Phoqus Pharmaceuticals plc                             Tel: 01732 870227

Dr Richard Mason, CEO
Dr Peter Johnson, CFO


Financial Dynamics                                     Tel: 020 7831 3113

David Yates/Sue Quigley

Nomura Code Securities                                 Tel: 020 7776 1200

Juliet Thompson/Phil Walker





Notes to Editors


About ChronocortTM

ChronocortTM is the first circadian endocrine treatment for congenital adrenal
hyperplasia ("CAH") and adrenal insufficiency ("AI").  ChronocortTM uses Phoqus'
proprietary QtrolTM modified release technology to provide a
delayed-and-sustained release profile of hydrocortisone to mimic the natural
over-night and early morning hormone levels found in healthy individuals that
are considered important in controlling both actual disease symptoms and also
reducing unwanted side effects resulting from excess steroid treatment.

Phoqus appointed a medical advisory board at the beginning of 2007 comprising
leading endocrinologists from Europe and the USA to assist the Company in the
design of the clinical development programmes able to demonstrate patient
benefits and clinical superiority of ChronocortTM over existing therapies for
both CAH and AI.

Some of the underlying intellectual property supporting the ChronocortTM product
is licensed from Diurnal Limited, a spin-out from the University of Sheffield
financed by Biofusion plc.  Phoqus and Diurnal collaborate on certain aspects of
ChronocortTM's development.



About Phoqus Pharmaceuticals

Phoqus Pharmaceuticals is a speciality pharmaceutical company that develops
differentiated products for use in high value, specialist indications. It seeks
to accelerate the rate and lower the risk of new drug development by applying
its novel re-formulation expertise and drug delivery technologies to finding new
indications for known, approved drugs. This avoids the high failure rate
typically associated with new chemical entities (NCEs) which often founder due
to safety issues encountered early in development.

The company's lead product is ChronocortTM for the treatment of patients with
cortisol deficiency due to diseases such as congenital adrenal hyperplasia and
Addison's Disease. It is differentiated from existing therapies because it is
designed to release steroid in a pattern that mirrors a healthy subject. At
present ChronocortTM is scheduled to reach the market in 2009/10.

Phoqus Pharmaceuticals aims to in-license product development opportunities from
academia and university spin-out companies. By collaborating with these groups
the company will access fundamental biological and clinical insights into
existing drug action and apply this knowledge to develop new indications for
those drugs. The company aims to capitalise on accelerated regulatory pathways
such as the priority review process to further fast track products to market.


www.phoqus.com


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            The company news service from the London Stock Exchange
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