According to the National Osteoporosis Foundation, approximately 10 million people in the US currently suffer from osteoporosis and another 34 million are estimated to have low bone mass, placing them at increased risk for the disease. By 2020, the number of cases of osteoporosis in the US is expected to reach 14 million, with over 47 million cases of low bone mass.

While there are many drugs available on the market for the treatment of osteoporosis, currently the human parathyroid hormone (hPTH (1-34)) is the only one to possess anabolic properties, stimulating new bone growth and resulting in an increase in bone strength and a decrease in fracture risk. It is widely considered the most effective treatment for osteoporosis; however, it is currently available only as a daily injection. According to a recent independent survey, this delivery mechanism is a major barrier to its use and significantly impedes compliance. Despite this limitation, anabolic agents are projected to be the fastest growing segment in the US osteoporosis market, reaching $1.24 billion by 2010 at an astounding compound annual growth rate of 52.3%.

TransPharma has recently completed initial Phase I human clinical trials on hPTH (1-34) which yielded extremely promising results.

A Phase Ib seven day, repeated dose study was conducted on 48 healthy, elderly, post-menopausal women. The study was designed to evaluate the safety and tolerability of ascending multiple doses of hPTH (1-34) patches and to compare the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of the transdermally delivered doses of hPTH (1-34) with that of FORTEO® administered subcutaneously.

Transdermal hPTH (1-34) was delivered using TransPharma’s fully integrated ViaDerm-Micro system, which is comprised of a proprietary pocket-sized device and 1 cm² dry hPTH (1-34) patch with demonstrated room-temperature stability.

Once-daily transdermal delivery of all doses tested in this trial demonstrated a safety profile similar to the one observed in the FORTEO® subcutaneous injection. All safety parameters (including calcium and phosphorous) of the different transdermal doses were within the normal range. Furthermore, all ViaDerm-hPTH (1-34) doses were very well tolerated by participants.

Pharmacokinetic profiles of hPTH (1-34) in the first and seventh day were similar, showing no accumulation of hPTH (1-34) levels and no deterioration in hPTH (1-34) systemic levels. These findings demonstrate the ViaDerm-hPTH (1-34) product’s ability to provide reproducible drug levels resulting in excellent inter- and intra-participant variability.

The PD profile of hPTH (1-34) was evaluated based on measuring the anabolic biomarker P1NP after six days of treatment. The results demonstrated a statistically significant increase in P1NP levels in each of the transdermal groups similar to that of the FORTEO® SC group. P1NP is the most reliable biomarker indicating bone formation in humans. These findings are very significant as they show initial PD effects predicting skeletal anabolic response to our ViaDerm-hPTH (1-34) treatment.

Transdermally delivered hPTH (1-34) of all doses showed desirable peak profiles with relative bioavailability of approximately 40%. This bioavailability is among the highest reported bioavailability of alternative drug delivery routes to subcutaneous administration.

ViaDerm-hPTH (1-34) is currently in Phase II clinical trials.

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