Speedel Starts Phase III Study of SPP301 in Diabetic Nephropathy
Speedel pipeline now contains two potential blockbuster drugs in Phase III.
Bridgewater, NJ (PRWEB via PR Web
Direct) July 7, 2005 -- Speedel announced today the start of its Phase III
study for SPP301, its once-a-day oral endothelin A receptor antagonist (ERA) in
the indication of diabetic nephropathy (diabetic kidney disease). The ASCEND(1)
study has begun with the first patient visit as per the schedule outlined by
Speedel in March 2005 when the company reported successful completion of the
Phase II clinical trials.
Dr. Alice Huxley, CEO of Speedel, commented:
“This milestone is of major strategic importance for Speedel as SPP301 is the
first drug which we have progressed into Phase III ourselves and it is a
considerable commercial opportunity. Our mature and diverse pipeline now
includes two Phase III products with blockbuster potential for major indications
– SPP100 partnered with Novartis for hypertension and SPP301 for diabetic kidney
disease. Both products have the potential to be first-in-class in their
respective indications, and demonstrate Speedel’s commitment to innovative
therapies for the large and growing markets of cardiovascular and metabolic
diseases.”
Dr. Jessica Mann, Medical Director of Speedel, added: “The
prevalence of diabetic nephropathy has been increasing dramatically in line with
the rising numbers of diabetes patients worldwide. Diabetic nephropathy has a
high mortality rate affecting an estimated 8.0 million people(2) diagnosed with
diabetes in the US, Japan, and major European countries. Therapeutic options are
limited at present. We believe SPP301 to have considerable potential as a
breakthrough therapy with significant medical benefits for the people who suffer
from this chronic disease.”
The Phase III pivotal ASCEND study is a
randomized, placebo-controlled morbidity and mortality study with over 2,000
patients, designed to assess time to doubling of serum creatinine, end-stage
renal disease or death in type 2 diabetes patients with overt diabetic
nephropathy(3). Patients will be given either 25mg or 50mg of SPP301 once per
day on top of standard therapy, or will receive standard therapy alone (i.e. the
placebo arm). The study, which has been discussed and agreed with the FDA and
the EMEA, will be conducted in about 260 clinical sites in Europe, USA and other
countries. This is an event-driven study, and the current best estimate is that
it will take approximately 3.5 years for enough events to occur in the composite
end-point to demonstrate statistically significant efficacy. In view of the high
unmet medical need diabetic nephropathy represents, SPP301 has been granted Fast
Track Designation(4) and has undergone a Special Protocol Assessment by the
FDA(5). This means that the review process is expedited and that assuming
successful registration, SPP301 could be launched in the USA in late 2009 and in
other countries in 2010.
The ASCEND study oversight bodies consist of a
Steering Committee, Data Safety Monitoring Board and an Endpoint Committee
consisting of highly experienced and well respected nephrologists, cardiologists
and diabetologists.
Professor Giancarlo Viberti, Chairman of the ASCEND
Steering Committee, stated: “SPP301 offers a truly novel approach to treating
diabetic kidney disease. The clinical results obtained so far are very
encouraging, and suggest that SPP301 could impact on morbidity and mortality in
patients suffering from this chronic disease. We look forward to working with
our colleagues worldwide on this large and rigorous study to demonstrate the
benefits of SPP301 over current therapies.”
The Steering Committee
members are professors Giancarlo Viberti, Johannes Mann, Luis Miguel Ruilope and
Kenneth Jamerson.
Giancarlo Viberti is professor of diabetes and
metabolic medicine at Kings College London, England. Professor Viberti was head
investigator of the Microalbuminuria Collaborative Study Group and is
Co-chairman of the Steering Committee for the ROADMAP (Randomised Olmesartan And
Diabetes MicroAlbuminuria Prevention) study.
Johannes Mann is professor
of medicine and director of the department of nephrology at the Schwabing
General Hospital in Munich, Germany. Professor Mann was principal investigator
for the HOPE (ramipril in Heart Outcomes Prevention Evaluation)
study.
Luis Miguel Ruilope is associate professor of internal medicine at
the Complutense University of Madrid, Spain, and head of the hypertension unit
at the 12 de Octubre Hospital in Madrid. Professor Ruilope was chairman of the
Endpoint Committee of the VALUE (Valsartan Antihypertensive Long-term Use
Evaluation) study.
Kenneth Jamerson is professor of internal medicine at
the University of Michigan, USA. Professor Jamerson was one of the lead
investigators of the AASK (African American Study of Kidney disease and
hypertension) study sponsored by the National Institute of Health.
The
ASCEND study with SPP301 is being managed by Speedel and run globally by
Quintiles, the world’s leading pharmaceutical services organization. Quintiles
has considerable experience in the execution of studies related to diabetes;
over the past 5 years it has worked on over 100 such studies, enrolling over
40,000 patients at over 5,500 clinical sites.
About SPP301
SPP301 is
a once daily oral endothelin A receptor antagonist that Speedel licensed from
Roche in October 2000 when it was in regulatory toxicology studies. SPP301, a
second generation ERA, developed out of Roche's endothelin research and drug
discovery program, and was specifically optimised for improved liver safety.
Speedel has taken the compound through a number of Phase I and exploratory Phase
IIa clinical trials before selecting the novel indication of diabetic
nephropathy for a Phase IIb clinical trial, the results of which were announced
in March 2005. Speedel has exclusive worldwide development and commercialisation
rights under the licensing agreement with Roche.
About Diabetic
Nephropathy
Diabetic Nephropathy is a new indication for this class of
compound, and the positive Phase II results for SPP301 indicate considerable
additional benefit on top of current therapies taken by patients suffering from
this chronic disease. Current therapies include – amongst others - drugs that
work on the renin-angiotensin system such as ACE inhibitors and ARBs, which have
an antihypertensive effect as well as a renoprotective effect and have been
shown to slow disease progression. However, 20-40% of patients with markers of
early disease still progress to advanced kidney damage and eventually End Stage
Renal Disease and death(6).
Definition: Diabetic nephropathy refers to
any deleterious effect on kidney structure and/or function caused by diabetes
mellitus. More specifically, diabetic nephropathy is thought of in stages, the
first being that characterized by microalbuminuria (30-300 mg urinary albumin
per 24 hours). This may progress to overt nephropathy or macroalbuminuria
(>300 mg urinary albumin per 24 hours). Later still, progressive renal
functional decline is characterized by significant decreases in glomerular
filtration rate accompanied by rises in serum creatinine, the final result of
which is End Stage Renal Disease.
Prevalence: According to the WHO in
2000, some 177 million people around the world had some form of diabetes,
including undiagnosed cases. About 20–40% of patients with type 1 or type 2
diabetes develop nephropathy(7). Current treatments (primarily antihypertensive
treatment and inhibition of the renin angiotensin system) slow progression of
DN, but it remains an unmet medical need, with a high mortality rate.
About Endothelin Receptor Antagonists
Pharmacological blockade of the
endothelin system constitutes a relatively new concept for modulating
haemodynamic and cellular functions. Substantial evidence from animal testing
and clinical studies suggest that endothelin plays a pivotal role in several
diseases such as hypertension, chronic heart failure, and chronic nephropathies.
Endothelin triggers renal vasoconstriction, decreases glomerular filtration rate
and modulates sodium excretion and water balance at the level of the proximal
tubule and medullary collecting ducts, by mechanisms that are still unclear.
Endothelin also stimulates the renin angiotensin system and atrial natriuretic
peptide release and inhibits vasopressin-mediated water re-absorption in the
collecting duct. In preclinical testing, chronic administration of Endothelin
Receptor Antagonists protected animals, including those with induced diabetes,
from developing renal injury.
About Speedel
Speedel is a
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 (Aliskiren), the first-in-class renin inhibitor, is
partnered with Novartis for Phase III development and commercialisation in
hypertension with filing for registration expected in 2006. Our pipeline covers
three different modes of action, and in addition to SPP100, includes SPP301 in
Phase III, SPP200 in Phase II, SPP630 and SPP635 in early 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 60 employees, including 34 experienced pharmaceutical scientists,
is located at our headquarters and laboratories in Basel, Switzerland and at
offices in New Jersey, USA and Tokyo, Japan. Since being founded in 1998 as a
private company, we have raised gross proceeds of CHF 169 million (approximately
EUR 109 million or USD 141 million) from private placements of equity securities
and a convertible loan and we have had total revenues, principally from
milestone payments, of CHF 57.7 million (approximately EUR 37 million or USD 48
million).
(1) Avosentan on doubling of Serum Creatinine, End stage renal
disease and death in Diabetic nephropathy
(2) Decision Resources, October
2004, based on research in US, Japan, France, Germany Italy, Spain, United
Kingdom
(3) Those patients with the more advanced form of the disease,
producing urinary albumin excretion of over 300mg per 24 hours
(4) Fast-Track
Designations granted by the FDA facilitate the development and expedite the
review of new drugs that are intended to treat serious or life-threatening
diseases. In addition, it demonstrates the potential to address unment medical
needs.
(5) Special Protocol Assessment is a procedure where FDA evaluates
protocols of pivotal studies to ensure that the study design is adequate to meet
scientific and regulatory requirements for a successful approval of an
NDA
(6) Diabetes Care, American Diabetes Association 2004
(7) Diabetes
Care, American Diabetes Association 2004
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.
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 e-mail protected
from spam bots
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 e-mail protected from spam
bots
www.speedel.com
# # #
Source : http://www.prweb.com/releases/2005/7/prweb258944.htm