Circassia Interim Management Statement
– Strong operational progress; clinical programmes on track –
– Encouraging results from third season follow-up study in grass allergy –
Oxford, UK – 11 November 2014: Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty biopharmaceutical company focused on allergy, today publishes its interim management statement for the period 1 July to 11 November 2014.
Circassia is developing a range of innovative allergy immunotherapy products. These Synthetic Peptide Immuno-Regulatory Epitopes (SPIREs) represent a new generation of disease-modifying therapies, which have the potential to provide safe and well-tolerated, efficacious, short-course treatment.
On track to complete recruitment into phase III registration study (CP007) by year end
– Total of 1,112 subjects randomised into study to date (94% of overall target of ≥1,182); sufficient subjects enrolled to complete randomisation based on historical screening success rates
– Enrolment now closed in North America and Europe
– Study centres opened in Russia to support potential registration filing in additional significant market; recruitment will close end November 2014
– Primary endpoint to be measured one year after dosing started; results continue to be anticipated H1 2016
Highly encouraging results from phase IIb third season follow-up study (TG002B)
– 85 subjects enrolled three grass pollen seasons after completion of short-course treatment (30 months after first dosing)
– Results show continued reduction in Total Rhinoconjunctivitis Symptom Score (TRSS) vs placebo after three seasons in two treatment groups (8 x 6 nmol and 4 x 12 nmol) despite no further doses
– Symptom score improvements were statistically significant over placebo after second and third seasons in subjects assessed after both seasons in the treatment groups above, despite small sample size and no further doses
HDM-SPIRE (house dust mite)
Positive results from phase II controlled asthmatic safety study (TH004)
– 30 subjects randomised into double-blind, placebo-controlled safety study
– Positive outcome with excellent safety profile demonstrated for HDM-SPIRE; well tolerated by all subjects, with no treatment-related adverse events and no difference between HDM-SPIRE and placebo in change in asthma control status
– Data enables inclusion of controlled asthmatic subjects in phase IIb field study (TH005), significantly extending target population
Initiated phase IIb field study (TH005)
– Enrolment initiated into 660 subject multi-centre, randomised, placebo-controlled study in North America, South Africa and Europe
– Study will compare short-course treatment (4 x 12 nmol dose) used in previous phase IIb study (TH002) with double course (8 x 12 nmol) and higher dose (4 x 20 nmol) regimens
Appointed Chief Commercial Officer
– Company’s first Chief Commercial Officer (Linda Szyper) appointed to develop and lead commercial operations and establish infrastructure in US and other key markets
– US subsidiary established; Linda becomes Circassia’s first US employee, and brings over 20 years’ commercial experience
Strengthened R&D team
– Clinical, CMC, Regulatory and QA teams strengthened to support Ragweed-SPIRE and Grass-SPIRE phase III study implementation and prepare for future regulatory filings
On 29 July 2014, Circassia announced its interim results for the six months ended 30 June 2014. These confirmed the Company’s robust financial position, with a cash balance of £201.9 million following the Company’s successful initial public offering in March 2014. The Company’s cash position remains strong, standing at £192.5 million on 30 October 2014.
Circassia is well positioned and on track to continue meeting its operational goals. By the end of 2014, the Company anticipates completing recruitment into its phase III Cat-SPIRE study (CP007), and completing its Ragweed-SPIRE asthmatic safety study (TR007). Positive results would enable inclusion of subjects with controlled asthma in the planned ragweed allergy phase III study, extending the target population to this important group. In addition, the Company continues phase III preparations for its grass allergy product candidate (Grass-SPIRE).
Over the coming months, Circassia will remain focused on advancing its portfolio of next generation allergy treatments, and on building a commercial presence, actively exploring options to establish infrastructure organically or through acquisition.
Steve Harris, Circassia’s Chief Executive, said:
“We continue to make good progress, both in our clinical development programmes and in building the team to bring our products to market. Our phase III study in cat allergy remains on track, and we are successfully recruiting the experts we need to advance our broad portfolio and establish our commercial infrastructure.”
“Encouraging results showing long-term symptom improvement in our grass allergy programme provide additional evidence of the potential benefits our treatments can offer allergy sufferers, while results from our controlled asthmatic study in house dust mite allergy further support the excellent safety profile we have seen with our product candidates to date.”
“During the last quarter we have maintained a strong focus on meeting our operational goals, and we remain committed to continuing that progress.”
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
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.