Interim Management Statement

RNS Number : 4013H

Circassia Pharmaceuticals Plc

19 May 2014

 



-- Circassia Interim Management Statement --

Oxford, UK - 19 May 2014:Circassia Pharmaceuticals plc ("Circassia" or "the Company") (LSE: CIR), a clinical-stage specialty biopharmaceutical company, today publishes its interim management statement for the period from 1 January to 18 May 2014.

OPERATIONAL HIGHLIGHTS

Cat-SPIRE

·      More than 1,000 subjects randomised to date in phase III registration field study (CP007)

- Recruitment target of at least 1,182 subjects on track to complete by year-end 2014

- Primary endpoint to be measured one year after dosing, results expected H1 2016

HDM-SPIRE (house dust mite)

·      Observational field study (TH003) successfully completed and reported in Q2 2014

- 109 subjects enrolled

- Provided valuable information to inform the design of the upcoming phase IIb study (TH005)

·      Positive scientific advice and pre-IND meeting for HDM-SPIRE held with the FDA in Q2 2014

- Agreed phase IIb field study design (TH005) in approx. 660 subjects, expected to start Q4 2014

·      Phase IIb two-year follow-up study (TH002A) has enrolled 72 subjects

- Data expected H2 2014

·      Phase II controlled asthmatic safety study (TH004) completed enrolment of 30 subjects

- Data expected H2 2014

Ragweed-SPIRE

·      Phase IIb chamber study (TR006) successfully completed recruitment

- 280 subjects randomised, results expected H1 2015

·      Phase II controlled asthmatic study (TR007) successfully initiated in February 2014

- Expected to enrol 48 to 60 subjects

Grass-SPIRE

·      Observational study (TG003) recruitment started in May 2014

- Expected to enrol 80 to 100 subjects

·      Phase II controlled asthmatic study (TG004) started in April 2014

- Expected to enrol 48 to 60 subjects

·      Regulatory approval received for Phase IIb third season follow-up study (TG002B)

- Recruitment of up to 118 subjects expected to start in June 2014

FINANCIAL REVIEW

As at 31 December 2013, the Company had cash balances¹ of £30.6 million.  During the first half of 2014, Circassia successfully raised over £200 million through an initial public offering (IPO) on the Main Market of the London Stock Exchange.  As a result, the Company is now fully-funded to continue development of the SPIRE product portfolio and bring Cat-SPIRE to market; the first of a new generation of allergy immunotherapy products that have the potential to overcome the limitations of current treatments.  At 30 April 2014, the Company had cash balances¹ of £209 million.

OUTLOOK

Upcoming efficacy data read-outs include the HDM-SPIRE phase IIb two-year follow-up study (TH002A) and the Grass-SPIRE phase IIb third season follow-up study (TG002B), both expected in H2 2014.  As set out in the IPO prospectus, both of these follow-up studies will involve smaller numbers of subjects than the original treatment studies and therefore Circassia does not expect the trials to deliver statistically significant results.  However, given the wealth of clinical data generated across the ToleroMune® technology platform to date, any identifiable trends will prove extremely helpful in the design of future clinical studies.  The Company remains focused on delivering strong progress across its SPIRE product portfolio and furthering the development of its earlier-stage SPIRE product candidates.

Steve Harris, Circassia's Chief Executive, said: "We have continued to maintain strong momentum during 2014.  Our successful IPO has given us the financial strength to bring Cat-SPIRE to market and accelerate the development of our ToleroMune® platform technology.  We have therefore focused heavily on driving patient recruitment for our ongoing clinical trials, leveraging our extensive clinical data set to inform the design of clinical trials, and planning the regulatory pathways for our key clinical programmes. 

"Our SPIRE product candidates have the potential to revolutionise the treatment of allergy and we remain focused on meeting our operational goals and ultimately preparing for the future launch of Cat-SPIRE."

-Ends-

For further information, please contact:

Circassia Steve Harris, Chief Executive Officer Julien Cotta, Chief Financial Officer Lara Flynn, Vice President Corporate Affairs	Tel: [phone]
J.P. Morgan Cazenove Gina Gibson / Siddharth Natarajan	Tel: [phone]
Peel Hunt James Steel / Clare Terlouw	Tel: [phone]
FTI Consulting Ben Atwell / John Dineen	Tel: [phone]

Notes to editors

1.   Circassia

Circassia is a specialty biopharmaceutical company focused on the development and commercialisation of a range of immunotherapy product candidates for the treatment of allergy. Established in 2006, the Company has used its innovative proprietary technology, ToleroMune® to develop a new class of allergy therapies, Synthetic Peptide Immuno-Regulatory Epitopes (SPIREs), which Circassia believes represents a step change to a new generation of allergy treatment. The Company's portfolio of product candidates is designed to treat a broad range of seasonal and perennial allergies. The lead product candidate Cat-SPIRE, a new treatment for cat allergy, is currently in phase III development and three other product candidates have completed phase IIb clinical studies. As Circassia continues to grow, the Company remains focused on its founding principle - a commitment to improving patients' lives by controlling immune responses. Further information is available at: www.circassia.co.uk.

1.     Cash, cash equivalents and short-term bank deposits

 

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