BiologicMD's lead development drug, PTH-CBD™, is focused on
helping patients avoid the destructive effects of
osteoporosis. The initial results for the compound are very
promising and have demonstrated five times the efficacy of
available bisphosphonate treatments with fewer side effects in
laboratory studies. According to the National
Osteoporosis Foundation, one in two women and one in four men will
be diagnosed with osteoporosis in their lifetime. The disease
can have devastating consequences as it weakens bones and causes
over 1.5 million osteoporosis patients to suffer a bone fracture
every year. Following a hip fracture, one in five patients
will die within a year; 30% will need long term care.
Highlighting the potential for the medication, the company was
selected in 2011 to receive a $2.3 million research award from the
Department of Defense to further development of PTH-CBD™.
The funding is part of the U.S. Department of Defense Peer
Reviewed Medical Research Program of the Office of the
Congressionally Directed Medical Research Programs (CDMRP).
The program received more than 600 applications and fewer than 10
percent were recommended for funding. Funds from the contract
will be used to develop the manufacturing platform for PTH-CBD™.
The next step for the company is to complete the animal
toxicology testing and then conduct a Phase I study in patients
with osteoporosis according to FDA requirements.
Reviews from the technical review committee highlight
BiologicMD's expertise in drug development, stating that, "the
investigators show a clear and concise understanding of bone
biology, drug discovery and drug development … This proposal could
have wide ranging consequences. Each stage of the proposed research
is carefully crafted in a logical sequence." BiologicMD's President
Paul Mlakar, Jr. added, "This approval process provides validation
for the science behind a compound that could help millions by
improving quality of life and saving lives."