Last updated on April 16, 2014 at 7:25 EDT

Circassia Initiates Pivotal Phase 3 ToleroMune® Trial in Cat Allergen-Induced Rhinoconjunctivitis

October 3, 2012

OXFORD, England, October 4, 2012 /PRNewswire/ –

Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today
announced the start of a pivotal phase 3 trial of its investigational ToleroMune(R) cat
allergy treatment for cat allergen-induced rhinoconjunctivitis.

The multinational study in almost 1,200 subjects incorporates input from leading
medical experts from Europe and North America, and follows a constructive End of Phase 2
meeting with the US Food and Drug Administration, Scientific Advice from the European
Medicines Agency and regulatory guidance from Health Canada, informing the path to
registration in each territory.

The ToleroMune(R) cat allergy treatment phase 3 study follows positive results from a
number of phase 2 trials. On September 17, the prestigious Journal of Allergy and Clinical
Immunology published phase 2 data showing patients had a significantly greater reduction
in symptoms compared with placebo one year after the start of the study, despite receiving
only a four-dose course of treatment over 12 weeks*.

“Allergy to cat dander is a common condition, and can greatly reduce patients’ quality
of life, impact work or school performance and exacerbate asthma symptoms,” said the
study’s Principal Investigator, Professor Harold S Nelson MD of National Jewish Health,
Denver, Colorado. “ToleroMune(R) cat allergy treatment represents a different therapeutic
approach to existing therapies, with phase 2 data suggesting it is the most exciting
innovation in the field of allergy for decades. Maintaining sustained allergen tolerance
over an extended period without requiring ongoing dosing would represent a major step
forward, and this large ToleroMune(R) cat allergy treatment phase 3 study aims to confirm
definitively if this can be achieved.”

“Circassia’s goal is to revolutionise the treatment of allergy, and the start of this
phase 3 study with our lead productis a major strategic milestone in this endeavour,” said
Steve Harris, Circassia’s CEO. “Tens of millions of people are allergic to cats in the
United States and Europe, and the disease can have a major effect on patients’ quality of
life. For many years sufferers have had limited treatment options, and currently no short,
simple treatment with long-lasting impact on the disease is available. We believe our
ToleroMune(R) technology has the potential to address this unmet medical need, and our
initiation of the final phase of clinical development demonstrates our commitment to
helping improve patients’ lives.”

Trial design

The randomised, double-blind, placebo-controlled, multi-centre, international field
study plans to enrol 1,182 patients aged 12 – 65 years old with cat allergen-induced
rhinoconjunctivitis. The trial will include approximately 110 centres located in the
United States, Canada and five countries in Europe. The study will evaluate the safety and
efficacy of both a single course and two courses of investigational ToleroMune(R) cat
allergy treatment, with each course consisting of four standardised doses administered
over 12 weeks. The trial’s primary efficacy endpoint will be the combined reduction in
rhinoconjunctivitis symptoms and rescue medication use one year after the start of
treatment, compared with placebo. The study is expected to complete in Summer 2014.

About cat allergy

Allergies are a significant global health issue. Allergic rhinoconjunctivitis (ARC)
affects up to 30% of adults and 40% of children in developed countries, and its prevalence
is rising. ARC reduces quality of life and impacts school and work attendance and
performance. In Continental Europe and the USA, cat allergy is one of the most common
forms of the disease, and affects 10 – 15% of those with ARC and / or asthma. As cat
dander is widespread in the human environment, and widely found in public buildings,
patients with cat allergy may experience significant symptoms despite attempting to avoid
exposure. Current treatment options include temporary symptom suppression with
antihistamines, corticosteroids and cromones, or long-term whole allergen immunotherapy,
which can take three – five years and has the potential to induce life-threatening
anaphylactic reactions.

About ToleroMune(R)

Circassia’s investigational cat allergy treatment is based on the company’s novel,
proprietary ToleroMune(R) technology. This uses rationally-designed combinations of
synthetic allergen-derived peptides to generate regulatory T cells to suppress allergic
responses and induce immune tolerance. Circassia’s lead ToleroMune candidate consists of
seven peptides derived from the major cat allergen Fel d 1. It has successfully completed
a number of phase 2 studies, which demonstrated that courses of short, simple treatment
can reduce patients’ symptoms and have a favourable safety profile. In a longer-term phase
2 follow-up study*, patients’ rhinoconjunctivitis symptoms were improved significantly one
year after the start of dosing compared with placebo, despite no further treatment after
the initial four doses given over 12 weeks (49.5% improvement in total symptom score vs
20.4% on placebo; p=0.01). This level of improvement is substantially higher than that
achieved in similar studies by a number of other treatment approaches used in allergy.

About Circassia

Circassia was founded by a team of highly experienced biotechnology scientists and
entrepreneurs, and is chaired by the former Chairman of GlaxoSmithKline, Sir Richard
Sykes. The company is based in the UK on the Oxford Science Park, and its joint venture
with McMaster University (Adiga Life Sciences Inc) is located in Hamilton, Canada.
Circassia’s ToleroMune(R) technology was developed originally by scientists at Imperial
College, London. Having successfully completed five fundraising rounds, Circassia has
raised approximately GBP105 million ($178 million) and is backed by a syndicate of
world-class institutional investors, including Imperial Innovations and Invesco Perpetual.

* Patel D et al. Fel d 1-derived peptide antigen desensitization shows a persistent
treatment effect 1 year after the start of dosing: A randomized, placebo-controlled study.
J Allergy Clin Immunol 2012 online 17 September.


        Steve Harris
        Tel: +44(0)1865-784574


        Rob Budge
        RJB Communications
        Tel: +44(0)1865-760969
        Mobile: +44(0)7710-741241

SOURCE Circassia

Source: PR Newswire