Circassia Completes Recruitment for Cat Allergy Treatment Pivotal Phase III Study
– Study on track to report in H1 2016 –
– 1,409 subjects randomised; 19% above target –
Oxford, UK – 8 January 2015: Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty biopharmaceutical company focused on allergy, today announces that it has completed recruitment into the pivotal phase III study of its cat allergy treatment, Cat-SPIRE. When recruitment closed on 31 December 2014, 1,409 subjects had been randomised into the study. The total recruited exceeds the minimum target of 1,182, and includes an additional 91 subjects enrolled at centres in Russia to support a potential filing in this significant market. The study is progressing as planned, and the Company remains on track to report the results in H1 2016.
Steve Harris, Circassia’s Chief Executive, said: “Our phase III Cat-SPIRE study is designed to efficiently assess our treatment in subjects who would benefit most from an effective new therapy. The team has made great progress in completing enrolment as planned into this international field study. We continue to be well placed to meet our timelines to complete the study in H1 2016, and, subject to the results, to file for regulatory approval later the same year.”
Phase III study design (CP007; or CATALYST)
The Cat-SPIRE study design follows guidance from the FDA, EMA and Health Canada, who advised that a single pivotal phase III trial is sufficient for registration. The study, which is being conducted under the name CATALYST (an abbreviation of Cat Allergy Study), is powered to meet each of the regulators’ statistical requirements. The double-blind, randomised, placebo-controlled, multi-centre field study has enrolled 1,409 cat allergic subjects aged 12 to 65 years with a cat at home and moderate or severe allergy symptoms (mean Total Rhinoconjunctivitis Symptom Score (TRSS) ≥ 10). The study allows inclusion of subjects with controlled asthma after an earlier clinical trial showed Cat-SPIRE to be safe and well tolerated in this group.
The study is ongoing in approximately 160 centres across the United States, Canada, six European countries and Russia, and is assessing a single course and two sequential courses of Cat-SPIRE, each of 4 x 6 nmol doses administered over 12 weeks. The primary efficacy endpoint is a comparison of the change in combined TRSS and rescue medication use scores one year after the start of treatment versus placebo. In an earlier phase IIb study, subjects who received 4 x 6 nmol doses of Cat-SPIRE had a statistically significant improvement in TRSS one year after beginning treatment compared with placebo (p=0.01).
For further information, please contact:
Steve Harris, Chief Executive Officer
Julien Cotta, Chief Financial Officer
Rob Budge, Corporate Communications
Tel: +44 (0)1865 405 560
J.P. Morgan Cazenove
James Mitford / Alex Bruce
Tel: +44 (0) 20 7742 4000
James Steel / Clare Terlouw
Tel: +44 (0) 20 7418 8900
Ben Atwell / Simon Conway / Mo Noonan
Tel: +44 (0) 20 3727 1000
Notes to editors
Cat allergy is a common condition, with skin prick testing suggesting it is the third most prevalent allergy in Europe and the sixth most prevalent in the United States. In Europe, approximately 8 – 10% of the population is estimated to be sensitised to cat allergens, while a national survey in the US estimated 17% of the population is sensitised.
Circassia’s candidate cat allergy treatment, Cat-SPIRE, contains a mixture of seven synthetically produced small peptides, identified from the main allergen responsible for cat allergy (Fel d 1) using the Company’s proprietary ToleroMune® technology. The treatment is designed to generate a regulatory T-cell response to induce tolerance to naturally occurring cat allergen.
Circassia is a specialty biopharmaceutical company focused on the development and commercialisation of a range of allergy immunotherapy product candidates. Established in 2006, the Company has used its proprietary ToleroMune® technology to develop a new class of therapies, the Synthetic Peptide Immuno-Regulatory Epitopes (SPIREs), which have the potential to revolutionise allergy treatment.
The Company’s portfolio of SPIREs is designed to treat a broad range of seasonal and perennial allergies. The most advanced, Cat-SPIRE, targets cat allergy and is currently in phase III development. Three other product candidates, targeting house dust mite, ragweed and grass allergies, have completed clinical proof-of-concept phase IIb 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.com.