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-- 12-month Phase 2 trial with subcutaneous Ostabolin-C provides strong clinical validation in osteoporosis patients; Phase 1 trial data support feasibility of noninjectable delivery of PTH analogues --
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West Conshohocken, PA, September 19, 2007 – Today Zelos Therapeutics announced
that it released data in two presentations at the 29th Annual Meeting of the American
Society for Bone and Mineral Research (ASBMR) that represent strong proof of concept
for cyclic PTH (1-31) (Ostabolin-C™) as an osteoporosis therapeutic. The data were
from a 12-month Phase 2 randomized, placebo-controlled, dose-ranging trial of
subcutaneous Ostabolin-C in post-menopausal women with diagnosed osteoporosis, and a
Phase 1 healthy volunteer study in post-menopausal women of an inhaled formulation of
Ostabolin-C developed with Nektar Therapeutics. Ostabolin-C, a proprietary cyclic
parathyroid hormone (PTH) analogue, is in late stage clinical development for the
treatment of osteoporosis.
“Zelos has clearly demonstrated that Ostabolin-C produces highly significant increases in
bone density, and that its clinical effects are established early and remain durable through
12 months of treatment,” said Brian MacDonald, MB, ChB, PhD, Chief Executive
Officer of Zelos. “Furthermore, the Phase 1 study represents the first time that an inhaled
formulation of a PTH analogue has shown an increase in serum markers of bone
formation in clinical use. We are very pleased that these studies have provided us with
such a strong clinical rationale for continued development.”
Phase 2 Study Results
The initial Phase 2 study evaluated the safety and efficacy of four months of treatment
with subcutaneous injections of Ostabolin-C in 261 post-menopausal women aged 45-75
with low bone mass. Approximately one-third of the study population had a history of
bone fracture. 198 study subjects then continued into an eight-month blinded extension
study. Study subjects received one of four active doses of Ostabolin-C (7.5, 15, 30 or 45
ěg/day) or placebo. The data showed that the primary endpoint was achieved with a
significant change in lumbar spine bone mineral density (LS-BMD) at one year. An
increase in LS-BMD was observed in all treatment groups at one year with a maximum
mean increase of 11%. The proportion of patients who developed a clinically relevant
LS-BMD increase of 3% or more was 79% after 4 months and 97% after 12 months in
the 45 ěg dose group. Significant increases in BMD of the hip were also observed.
Adverse events were in line with what is typically expected from PTH analogues.
Hypercalcemia was only observed with significantly higher incidence than placebo in the
45 ěg group. Most occurrences were mild.
The Phase 2 results were discussed by Anthony Hodsman, M.D., Professor of Medicine,
University of Western Ontario, in a podium presentation at ASMBR on Tuesday,
September 18 at 10:45 a.m. Hawaii Time.
“Without therapeutic intervention, a patient with osteoporosis who has fractured his or
her hip, spine or wrist is at significant risk of another fracture,” commented Dr.
Hodsman. “With only one FDA-approved anabolic agent, there is a clear need for new
therapies that can safely and effectively build new bone. This robust Phase 2 study
clearly demonstrates that Ostabolin-C should be further investigated as a novel PTH
analogue to reduce fracture risk in patients with osteoporosis.”
Phase 1 Study Results
Zelos also presented Phase 1 data for an inhaled formulation of Ostabolin-C delivered
with the Nektar T326 inhaler. The randomized, double-blind, placebo-controlled repeat
escalating dose study evaluated the pharmacokinetic, safety, and efficacy profiles of
inhaled Ostabolin-C in healthy post-menopausal women. Treatment duration was 28
days. The study demonstrated the ability of inhaled Ostabolin-C to increase serum
markers of bone formation to levels comparable with the effect of subcutaneous delivery
of Ostabolin-C at a similar time point. The safety profile of inhaled Ostabolin-C was
consistent with the PTH analogue class and no serious adverse events were reported.
There were no treatment-emergent pulmonary or cardiovascular adverse events and no
effects on pulmonary function were identified.
The Phase 1 trial was exhibited in a Plenary Poster presentation on Sunday, September 16
and Monday, September 17.
About PTH in the Treatment of Osteoporosis
Osteoporosis is a major public health issue in the United States and worldwide, affecting
more than a third of post-menopausal women but also a significant and increasing
number of elderly men. It is a silent disease and many sufferers present to the physician
for the first time when they experience a hip, spine or wrist fracture. Such patients have
already lost a large amount of bone strength and are at very high risk of another fracture.
The consequences of recurrent osteoporotic fractures are severe in terms of pain,
disability, loss of independence and increased mortality. To effectively reduce fracture
risk in such patients, therapies to create new bone and actively increase bone strength are
required. PTH (1-34) is the only such bone building therapy currently approved in the
U.S. and has been shown to reduce fracture rates in patients with severe osteoporosis by
65%. Despite this proven efficacy, the majority of patients with severe osteoporosis do
not receive PTH therapy. Therefore, there is a significant opportunity for new approaches
to PTH therapy to enter the market that can overcome the existing dosing, formulation
and tolerability limitations.
About Zelos Therapeutics, Inc.
Zelos Therapeutics, Inc. is a privately held biopharmaceutical company developing novel
therapies for patients suffering from conditions responsive to PTH-based therapeutics.
The Company is in late-stage clinical development with Ostabolin-C™, a PTH analogue
designed to improve upon the safety and efficacy of current therapies in the large and
rapidly growing osteoporosis market and which may become a leading osteoporosis
therapeutic. To address the need for more convenient and patient friendly, non-injectable
dosing of Ostabolin-C, the Company is exploring alternative delivery methods including
a collaboration with Nektar Therapeutics in the development of an inhaled dry powder
formulation of Ostabolin-C. Zelos is also developing its PTH analogues in other
indications, including the treatment of fracture in patients with osteoporosis.
Zelos is led by a team of seasoned biopharmaceutical executives, and is based in West
Conshohocken, Pennsylvania. More information is available at
www.zelostherapeutics.com.
Ostabolin-C is a trademark of Zelos Therapeutics, Inc.
# # #
Zelos Contacts:
Jay Mohr
Chief Business Officer
(610) 825-5224
Kari Watson
MacDougall Biomedical Communications
(508) 647-0209
kwatson@macbiocom.com
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