Circassia Extends its Clinical-Stage Portfolio With Phase II Trials of T-Cell Vaccines Against House Dust Mite and Cat Allergies
biopharmaceutical company focused on allergy, today announced that it has
initiated phase II clinical trials of its T-cell vaccines targeting house
dust mite and cat allergies. With the start of these studies, and the ongoing
trial of Circassia’s ragweed allergy (hay fever) T-cell vaccine, the company
now has three clinical development programmes in phase II. Each of these
builds on earlier successful phase II results with the company’s
ToleroMune(R) technology, which scientifically validated the novel use of
T-cell vaccines in the treatment of allergy, and identified the optimal
dosing regimens to progress into late-stage development.
In Circassia’s cat allergy trial, which is underway in
patients will be randomised to receive placebo or one of two regimes of the
company’s T-cell vaccine. This study is the first to test Circassia’s novel
room-temperature-stable ToleroMune formulation. This offers great potential
practical advantages compared with existing allergy desensitisation
treatments, which are inherently unstable and require cold chain distribution
and storage. During the study, the volunteers will be exposed to aerosolised
cat dander in an environmental exposure chamber, both before and after
treatment, to measure the effect of the ToleroMune T-cell vaccine.
Circassia has also initiated the first clinical study of its T-cell
vaccine against house dust mite allergy, which is underway in
The double-blind, placebo-controlled, randomised trial will include 50
allergy patients. The active treatment groups will receive four standardised
doses of the ToleroMune T-cell vaccine over several weeks. This approach
contrasts with current immunotherapies, which require many months of
escalating doses and maintenance treatment over a number of years. During the
trial investigators will ‘challenge’ the volunteers with house dust mite
allergens to assess the therapeutic effect of Circassia’s T-cell vaccine.
“The start of these two studies demonstrates the rapid clinical advance
of Circassia’s T-cell vaccines. With this further broadening of our
portfolio, Circassia now has three development programmes in phase II,
targeting some of the most common allergies in the world,” said
Circassia’s CEO. “We are committed to continuing this rapid pace of
development, to ensure we can bring these breakthrough T-cell vaccines to
market as soon as possible. We believe that patients can benefit greatly from
our ToleroMune allergy therapies, which offer the prospect of simple,
convenient and effective treatment while minimising the risk of the severe
and sometimes life-threatening side effects associated with many existing
immunotherapies.”
About Circassia’s allergy T-cell vaccines
Circassia’s range of allergy T-cell vaccines is based on its proprietary
ToleroMune(R) technology. This technology utilises allergen epitopes to
generate regulatory T cells that suppress allergic immune responses. Clinical
results with Circassia’s cat allergy T-cell vaccine show that short treatment
regimes can greatly reduce patients’ symptoms, without the need for adjuvants
or other immune stimulators, while proving extremely well tolerated. As a
result, the company’s allergy T-cell vaccines offer major potential clinical
benefits compared with existing therapies, and consequently have significant
market opportunities. Over 150 million people suffer from allergic rhinitis
in the US and
billion
ToleroMune technology has additional potential regulatory and supply
chain benefits. The short peptides utilised in Circassia’s vaccines are
manufactured chemically, in contrast to existing allergen immunotherapies,
which are purified from natural sources. Circassia’s approach applies the
chemistry, manufacturing and control standards associated with conventional
pharmaceuticals to its allergy T-cell vaccines. This fits with changes in the
European regulatory environment, where authorities are increasingly treating
allergen immunotherapies as pharmaceutical products, and requiring
elimination of the batch-to-batch potency variability that is an intrinsic
feature of many current treatments.
About Circassia
Circassia has a highly experienced management team with a proven track
record in product development and commercialisation. Having successfully
completed three fundraising rounds the company is backed by a syndicate of
world-class venture capital and institutional investors, including Imperial
Innovations, Invesco Perpetual, Goldman Sachs and Lansdowne Partners.
For more information please visit http://www.circassia.co.uk.
Contacts
Steve Harris Rob Budge
CEO RJB Communications
Circassia Tel: +44(0)1865-760969
Tel: +44(0)1865-784574 Mobile: +44(0)7710-741241
SOURCE Circassia Ltd