SPEEDEL REPORTS SUCCESSFUL SPP635 PHASE IIA TRIAL IN HYPERTENSION
- Next generation renin inhibitor to continue Phase II profiling in
diabetic patients -
Basel/Switzerland and Bridgewater NJ/USA, 28 June 2007
Speedel (SWX: SPPN) today announced that it has reached another
significant milestone in the development of its family of renin
inhibitors with the successful completion of a Phase IIa
proof-of-concept clinical trial with SPP635 for the treatment of
hypertension. Based on these positive results, the company is to
continue developing SPP635 in Phase II in a special population of
diabetic patients with mild-to-moderate hypertension. This compound
is the first of a next generation of renin inhibitors following
Speedel's lead product SPP100 (aliskiren, Tekturna/Rasilez[1]), which
is partnered with Novartis and recently obtained US marketing
approval from the FDA and a positive opinion from the CHMP in
Europe[2]. SPP635 is the most advanced compound in the SPP600 series
and is one of several new proprietary renin inhibitors invented by
Speedel Experimenta, the company's late-stage research unit.
Phase IIa results demonstrate strong efficacy and good tolerability
The trial had a double-blind, placebo-controlled, randomised,
parallel design and it evaluated patients treated with a single
dosage level of SPP635 once-daily for 4 weeks. It studied the safety
and efficacy of SPP635 in 35 male and female patients (20 patients
receiving SPP635 and 15 receiving placebo) with mild-to-moderate
hypertension by measuring office and ambulatory blood pressure[3].
SPP635 was safe and well tolerated over the 4 week period. There were
no serious adverse events reported nor were there any clinically
significant changes in laboratory safety parameters. Sitting systolic
blood pressure was significantly reduced by 17.9 mmHg from 156.6±9.1
mmHg at baseline (mean ± SD) to 138.7±13.3 mmHg in the SPP635 treated
group after 4 weeks (p<0.001). The placebo group remained unchanged
(156.1±9.0 to 153.2±8.9 mmHg; baseline vs. end of treatment).
Diastolic blood pressure was also significantly reduced by 9.8 mmHg
from 91.3±7.8 to 81.5±8.2 mmHg (p<0.001) in the SPP635 treated group
compared to the placebo treatment (95.3±5.1 to 93.3±5.4 mmHg). These
blood pressure measurements were taken at trough, 24 hours after the
previous medication. Similar results were observed for ambulatory
blood pressures, which were reduced both during the day as well as in
the night.
The half-life of SPP635 had been previously reported to be
approximately 24 hours suggesting once daily administration; these
latest ambulatory blood pressure data confirm the use as of SPP635 as
an once-a-day drug. The extent of blood pressure reduction is similar
to those reported for the renin inhibitor SPP100
(aliskiren,Tekturna/Rasilez)[4].
Hans R. Brunner, Professor Emeritus of Medicine at the University of
Lausanne, and acting Speedel Medical Director, commented: "These
positive results show that SPP635 has comparable efficacy to other
blood pressure lowering therapies. It will be exciting to see the
first follow-on renin inhibitor to SPP100 demonstrate its potential
in diabetic patients in further clinical trials."
Alice Huxley, CEO of Speedel, commented: "This success with SPP635
reinforces Speedel's strategy of building a family of renin
inhibitors which can be profiled for both general and special patient
populations. We continue to leverage our exceptional knowledge in
renin inhibition which we believe has the potential to be the next
gold standard for the treatment of different cardiovascular
diseases."
Continued Phase II development
Clinical profiling of SPP635 will continue this year in special
populations with a further study planned in diabetic patients with
mild-to-moderate hypertension. This harder to manage patient group
has been shown to respond to SPP100 to controlling blood pressure
alone and in combination with an ACE-I[5][6]. Further details about
this proof-of-concept Phase II trial will be announced later in 2007
when it commences. The trial will be carried out in Europe with
results due in the second half of 2008.
Speedel's next generation renin inhibitors include other compounds in
the SPP600 series, the SPP1100 series with SPP1148 due to report
first Phase I results in Q42007, and the SPP800 series currently in
late-stage pre-clinical profiling. Each series is a different
chemical class with distinct properties and is protected by different
patent applications.
About SPP600 series
SPP635 is the most advanced compound of the SPP600 series of renin
inhibitors being developed by Speedel. The company has made
significant progress in the optimisation and development of this
series of newly synthesised compounds by using rational drug design,
including computer assisted molecular modelling techniques,
state-of-the art preclinical disease models and human microdosing.
In December 2001, Speedel acquired a worldwide exclusive license from
Roche covering its entire programme in renin inhibition. This license
allows Speedel to use the acquired know-how for lead optimisation of
its own compounds designated as the SPP600 series. Speedel holds full
development and commercialization rights for these product candidates
under the license agreement with Roche. If Speedel decides to offer
rights to any Speedel compound from the series to a third party,
Roche has a right of first negotiation with respect to such rights.
If Roche has not expressed its interest in acquiring such rights
within a defined period of time, or the parties have not reached an
agreement on the terms of such rights, Speedel is free to grant such
rights to any third party.
About Hypertension
Hypertension is a common disorder in which blood pressure is
abnormally high, placing undue stress on the heart, blood vessels and
other organs such as the kidney and the brain. Blood pressure is
determined in two phases as the heart contracts and relaxes. Systolic
blood pressure represents the force that blood exerts on the walls of
arteries as the heart contracts to pump out blood. Diastolic blood
pressure represents the force as the heart relaxes to allow the blood
to flow into the heart.
Due to its wide prevalence and impact on cardiovascular health,
hypertension is a major cause of disease and death in Europe and
North America. More than one in three Europeans and North Americans
over the age of 35 suffers from hypertension - but for the vast
majority of patients who undergo hypertension treatment, the causes
of high blood pressure are unknown. More than 40 % of patients
undergoing treatment with current therapies do not reach targeted
blood pressure levels, and so there is a considerable unmet medical
need.
The latest potential therapeutic agents for hypertension are renin
inhibitors. Renin is an enzyme produced in the kidneys in response to
reduced renal perfusion. Through a cascade of biological events,
renin acts to bring about sodium retention, an increase in blood
pressure, and restoration of renal perfusion, which shuts off the
signal for renin release. For hypertensive individuals, renin
inhibitors are currently being investigated as a therapy that may
provide benefits over current therapies to reduce blood pressure,
decrease salt retention and may protect end organs such as the
kidney, heart and brain.
About Speedel
Speedel is a public biopharmaceutical company that seeks to create
value for patients, partners and investors by developing innovative
therapies for cardiovascular and metabolic diseases. Speedel is a
world leader in renin inhibition, a promising new approach with
significant potential for treating cardiovascular diseases. Our lead
compound SPP100 (Tekturna/Rasilez [i]), the first-in-class direct
renin inhibitor, was in-licensed from Novartis in 1999 and
licensed-back to Novartis Pharma in 2002 for further development and
commercialisation; SPP100 was approved by the FDA in the US in March
2007, and filed by Novartis with the EMEA in the EU in Q3 2006. Our
pipeline covers three different modes of action, and in addition to
SPP100, includes SPP301 in Phase III (on hold), SPP200 in Phase II,
SPP635 in Phase Il, SPP1148 in Phase I and several pre-clinical
projects.
Speedel develops novel product candidates through focused innovation
and smart drug development from lead identification to the end of
Phase II. We either partner with big pharma for Phase III and
commercialisation in primary-care indications, or we may ourselves
complete Phase III development in specialist indications. Candidate
compounds for development and the company's intellectual property
come from our late-stage research unit Speedel Experimenta and from
in-licensing. Our team of approximately 70 employees, including over
30 experienced pharmaceutical scientists, is located at our
headquarters and laboratories in Basel, Switzerland and at offices in
New Jersey, USA and Tokyo, Japan.
In January 2007 the company raised gross proceeds of CHF 55.5 million
(approximately EUR 34.3 million or USD 44.5 million) through a
convertible bond issue. In March 2006 the company raised gross
proceeds of CHF 83.95 million (approximately EUR 53m or USD 64m)
through the public offering of 500,000 treasury shares. Previously,
as a private company, we raised gross proceeds of CHF 255 million
(approximately EUR 157 million or USD 204 million) from private
placements of equity securities and two convertible loans including
the conversion premiums. We have had total revenues, principally from
milestone payments, of CHF 57.7 million (approximately EUR 37 million
or USD 44 million). The company's shares were listed in September
2005 on the SWX Swiss Exchange under the symbol SPPN.
Forward looking statements
This press release includes forward-looking statements that involve
substantial risks and uncertainties. These forward-looking statements
are based on our current expectations and projections about future
events. All statements, other than statements of historical facts,
regarding our strategy, future operations, future financial position,
future revenues, projected costs, prospects, plans and objectives of
management are forward-looking statements. The word "may" and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these identifying
words. We may not actually achieve the plans, intentions or
expectations described in these forward-looking statements and you
should not place undue reliance on them. There can be no assurance
that actual results of our research and development activities and
our results of operations will not differ materially from these
expectations. Factors that could cause actual results to differ from
expectations include, among others: our or our partners' ability to
develop safe and efficacious products; our or our partners' ability
to achieve positive results in clinical trials; our or our partners'
ability to obtain marketing approval and market acceptance for our
product candidates; our ability to enter into future collaboration
and licensing agreements; the impact of competition and technological
change; existing and future regulations affecting our business;
changes in governmental oversight of pharmaceutical product
development; the future scope of our patent coverage or that of third
parties; the effects of any future litigation; general economic and
business conditions, both internationally and within our industry,
including exchange rate variations; and our future financing plans.
-- Ends --
[1] Tekturna® and Rasilez® are Novartis trademarks in the USA and
Europe, respectively
[2] Food and Drug Administration (FDA) and Committee for Medicinal
Products for Human Use (CHMP)
[3] Ambulatory blood pressure is measured by a portable device worn
by the patient over 24 hours at pre-determined intervals
Office blood pressure (systolic and diastolic) is measured when the
patient is in the physician's office at pre-determined intervals
[4] Aliskiren Reduces Blood Pressure and Suppresses Plasma Renin
Activity in Combination With a Thiazide Diuretic, an
Angiotensin-Converting Enzyme Inhibitor, or an Angiotensin Receptor
Blocker O'Brien E; Barton J; Nussberger J; Mulcahy D; Jensen C;
Dicker P; Stanton A, Hypertension. 2007;49:276-284.
[5] Angiotensin Converting Enzyme Inhibitor
[6] Uresin Y et al. Aliskiren, a novel renin inhibitor, has greater
BP lowering than ramipril and additional BP lowering when combined
with ramipril in patients with diabetes and hypertension. European
Society of Hypertension. 16th European Meeting on Hypertension. June
12-15, 2006; Madrid, Spain.
[i] Tekturna/Rasilez® are Novartis trademarks
For further information please contact
Nick Miles
Director Communications & Investor Relations
Speedel
Hirschgässlein 11
CH - 4051 Basel
Switzerland
T +41 (0) 61 206 40 00
D +41 (0) 61 206 40 14
F +41 (0) 61 206 40 01
M +41 (0) 79 446 25 21
E nick.miles@speedel.com
www.speedel.com
Frank LaSaracina
Managing Director
Speedel Pharmaceuticals Inc
1661 Route 22 West
P.O. Box 6532
Bridgewater, NJ 08807
United States of America
T +1 732 537 2290
F +1 732 537 2292
M +1 908 338 0501
E frank.lasaracina@speedel.com
www.speedel.com