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Aursos,inc. Executive Summary
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Company Background |
Aursos is a biotechnology company leveraging
the evolutionary advantages the black bear has developed over millions of years to escape the debilitating effects of osteoporosis
and other bone related diseases. Black bears hibernate for 4-6 months each year without loss of bone density whereas humans
placed on bed rest due to age, surgery or an accident can show detectable bone loss in just 14 days. Black bears have developed
a mechanism to maintain bone mass while inactive, while inactivity in humans generally results in osteoporosis. This provides
a poor prognosis for the elderly, patients with spinal cord injuries, and those whom are bed ridden or otherwise immobilized
by disease. The Company’s platform technology is based on the amino acid sequence
of Black Bear Parathyroid Hormone (BB-PTH). This platform consists of three distinct constructs; BB-PTH 1-34, BB-PTH 1-84
(full-length) and BB-PTH 7-84. The strategic vision for the Company is to develop each of the BB-PTH constructs for different
clinical indications. Aursos has partnered with Proteos, Inc. (Kalamazoo, MI) which has developed
a recombinant process in E. coli for efficient production and purification of these peptides. Though inactivity leads to bone loss in humans, bears maintain balanced bone remodeling and do not lose bone during
hibernation, a period that may reach 6 months of the year. Bears may prevent bone loss during disuse
via the anabolic effects of endogenous parathyroid hormone (PTH). Serum PTH levels increase during hibernation
and are positively correlated with osteocalcin (a serum marker of osteoblast bone formation activity) in hibernating and active
bears. Thus, PTH may govern the mechanism by which bears maintain balanced bone remodeling and prevent
osteoporosis during disuse and may lead us down a development path to novel and highly effective treatments for humans. BB-PTH has important implications in not only the osteoporosis market but the orthopedic market as
well. The disuse osteoporosis market is underserved and Forteo®, the only anabolic agent marketed in the U.S.,
is approved for 1) treatment of postmenopausal women with osteoporosis at high risk for fracture, 2) increase of bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture osteoporosis and 3) treatment of men and women with glucocorticoid-induced osteoporosis at
high risk for fracture.Only one product is currently FDA approved for site-specific,
local application in spinal fusions (rBMP-2, INFUSE Bone Graft) and has been associated with significant morbidity and mortality.
No bone-building (i.e. anabolic) products are currently approved for site-specific application to promote “accelerated
healing” in open orthopedic procedures such as long bone fractures. The
intent of the Company is to develop BB-PTH for 1) disuse osteoporosis conditions and 2) site-specific delivery in spinal fusions
and long bone fractures, to promote healing, via the anabolic actions of this peptide. The peptide will be delivered Sub-Q
as an injection for disuse indications and as a resorbable gel for site-specific applications. The Company was established in 2008 under the guidance of The Apjohn Group, LLC (www.apjohngroup.com), a business development accelerator in Kalamazoo, MI. The Apjohn Group,
brings together valuable resources, management talent and angel/seed financing to help promising life science start-ups achieve
milestones where they would be attractive to professional investors at stepped up valuations. Aursos
licensed its technology from the laboratory of Dr. Seth Donahue of Michigan Technological University (Houghton, MI). Dr. Donahue and his
graduate students obtained blood from hibernating bears and sequenced black bear (Ursus americanus) Parathyroid Hormone (PTH)
peptides and wrote IP entailing composition and methods for their use. |
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Markets |
Osteoporosis Osteoporosis
is currently a health issue for approximately 44 million Americans (10 million with osteoporosis, and an additional 34 million
with low bone mass who are at risk for osteoporosis). These numbers are expected to rise to 62 million Americans (14 and 48
million, respectively) by 2020. Approximately 40% of women and 13% of men over age 50 are at risk for spine,
hip or forearm or other long bone fractures within their lifetime. The costs associated with treatment of osteoporosis-related
fractures were approximately $18 billion dollars in 2002, and continues to climb.
In addition to primary (age-related) osteoporosis, disuse osteoporosis is an important
clinical problem, especially for patients partially or completely immobilized due to long bone fracture, stroke, muscular
dystrophy or spinal cord injury. Disuse further increases fracture rates primarily because reduced
skeletal loading causes unbalanced bone remodeling, which leads to bone loss (disuse osteoporosis). Orthopedics
In 2006, more than $1.8 billion was spent
on spinal fixation and dynamic stabilization devices in the U.S. Sales of these products are expected to grow at a compound
annual rate of 10.4% reaching more than $3.2 billion in the year 2012. The incidence of spine disorders totaled approximately
75,000 in 2006. Back pain is the second most common medical condition for which individuals seek treatment, accounting for
more than 50 million physician office visits annually in the U.S. It is estimated that more than 75% of the entire U.S. population will be affected by low back pain over the course of their lifetime. Orthopedics In 2006, U.S. sales of orthopedic implant, reconstruction, and trauma products totaled approximately $12.2 billion. Sales of these
products are expected to increase at a compound annual rate of 6.9%, reaching more than $18.1 billion in the year 2012. |
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Pre-clinical Proof-of-Efficacy Established | Assessment of bone building cell (osteoblast) survival has been accomplished.
These in vitro experiments demonstrated that mouse osteoblasts treated with BB-PTH 1-34 have a greater potential
to survive and produce new bone compared to cells treated with human PTH 1-34. This finding suggests BB-PTH has potential
to be a more efficacious osteoporosis drug than human PTH because of its enhanced ability to maintain osteoblast survival. A proof-of-concept in vivo study was also completed and demonstrated that
human and BB-PTH 1-34 increase cortical bone strength equivalently in young healthy male rats following short (6 week) treatment.
The Company has also recently completed a study in which BB-PTH 1-34 was compared to human PTH 1-34, in the validated preclinical
ovariectomized (OVX) rat model. In this study, rats rapidly lost bone volume over a 6 week period following OVX. They were then treated with either
vehicle or ascending doses of human or bear PTH (3, 10, or 30 ug/kg, Sub-Q). Injections were performed 5 times per week for
8 weeks and then the animals were terminated and the bones assessed utilizing µCT. Both human and bear PTH 1-34 restored
bone, in a dose-dependent manner, returning bone volume to pre-OVX levels. Most recently, studies on male mice demonstrated that BB-PTH 1-84 is a more efficacious at increasing bone density and
strength than human PTH 1-84. Recent studies conducted in long
bone defect models in rodents demonstrate that the Company may be able to compete with existing agents which promote accelerated
healing of the fracture site. This work has important implications for not only patients requiring spinal fusions and long
bone repair from falls and other injuries but also has distinct applications to the military when soldiers suffer debilitating
bone injuries on the battlefield and require open orthopedic procedures to repair the defect. | | Clinical Development Plan and Commercialization Strategy | Assessment of bone
building cell (osteoblast) survival has been accomplished. These in vitro experiments demonstrated that mouse osteoblasts
treated with BB-PTH 1-34 have a greater potential to survive and produce new bone compared to cells treated with human PTH
1-34. This finding suggests BB-PTH has potential to be a more efficacious osteoporosis drug than human PTH because of its
enhanced ability to maintain osteoblast survival.
A proof-of-concept in vivo study was also completed and demonstrated that human and BB-PTH
1-34 increase cortical bone strength equivalently in young healthy male rats following short (6 week) treatment. The Company
has also recently completed a study in which BB-PTH 1-34 was compared to human PTH 1-34, in the validated preclinical ovariectomized
(OVX) rat model. In this study, rats rapidly lost bone volume over a 6 week period following OVX. They were then treated with
either vehicle or ascending doses of human or bear PTH (3, 10, or 30 ug/kg, Sub-Q). Injections were performed 5 times per
week for 8 weeks and then the animals were terminated and the bones assessed utilizing µCT. Both human and bear PTH
1-34 restored bone, in a dose-dependent manner, returning bone volume to pre-OVX levels. Most recently, studies on male mice demonstrated
that BB-PTH 1-84 is a more efficacious at increasing bone density and strength than human PTH 1-84.
Recent
studies conducted in long bone defect models in rodents demonstrate that the Company may be able to compete with existing
agents which promote accelerated healing of the fracture site. This work has important implications for not only patients
requiring spinal fusions and long bone repair from falls and other injuries but also has distinct applications to the military
when soldiers suffer debilitating bone injuries on the battlefield and require open orthopedic procedures to repair the defect.
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Financing
| With an approval of BB-PTH for DMD, Aursos
believes it will have substantial value and be in a position to raise additional capital to pursue the many other indications
for this product line. Aursos is seeking
$13 million to take the company through Phase II clinical trials for a DMD indication. The company estimates that $2.5
million of the above will fund through NIH and STTR grants and $10.5 million through Series A preferred stock. An additional
$4.0 million will be needed to file the NDA based on a projected 40 patient pivotal Phase III study. |
Management Team | Gary H. Stroy President & CEO Phone: 650-704-8927 ghstroy@aursos.com
Ronald Shebuski, Ph.D. Chief Scientific Officer Phone: 703-845-5429 ron@aursos.com
Terry Lewis Chief Financial Officer Phone: 269-806-3316 terry@aursos.com Seth Donahue, Ph.D. Chief Scientific Advisor Phone: 906-487-1729swdonahu@mtu.edu |
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