With Transpharma, osteoporosis can be treated by delivering drugs through the skin, which now are only available via injection.Israeli biomed startup TransPharma Medical Ltd. hopes to change the way drugs are delivered into our bloodstream – goodbye needles, hello patches. That could be welcome news for the millions of Americans who suffer from severe osteoporosis, the disease caused by the gradual reduction in bone density due to the loss of essential bone minerals, such as calcium.

According to Transpharma CEO Dr. Daphna Heffetz, drugs to treat the disease which contain the molecule hPTH (1-34) are administered today through daily injections into the blood stream.

“Imagine if these patients could receive the same drug via a patch on their skin instead which can be administered by themselves in the comfort of their own home,” she told ISRAEL21c.

Earlier this year, Transpharma announced promising human clinical results demonstrating efficient and effective transdermal delivery of hPTH (1-34), and plans to bring its developing product to an advanced clinical stage before seeking a partner to take it to market.

The secret ingredients of Transpharma’s success is their patented transdermal drug delivery technology RF-MicroChannels. It creates microscopic channels in the very outer layer of the skin, which enables the efficient delivery of a wide range of drug molecules via the skin, including macromolecules and proteins, currently only deliverable via injection. The process is fueled by Transpharma’s ViaDerm system.

“Viaderm is actually composed of two components – a reusable handheld electronic control unit, a disposable microelectrode array designed to be used with drug patches, and the patch itself,” said Heffetz, explaining the ease with which the system operates.

After a second, a blinking LED and beep indicate that the RF-MicroChannels have been formed and the treatment site is now ready for drug patch application. With the patch in place, the medication easily travels into the viable skin layers via the RF-MicroChannels that have been formed, and are open for about 24 hours.

“The major features of our delivery system is its ability to deliver high molecular drugs like proteins in an extremely efficient way – with a high yield. And we’ve succeeded in developing a home use delivery system that’s simple to handle, requiring no special training, at an extremely low cost.”

In addition, because very few drugs can passively diffuse across the skin at therapeutically useful levels, the dimensions and density of the RF-MicroChannels created can be precisely controlled, depending on the requirements of the drug. This means the ability to deliver a range of different-sized molecules, both small and large.

In addition, the ViaDerm platform will enable increased dose rates, improved compliance, and controlled delivery of therapeutic doses of small molecules having different physicochemical nature. According to Heffetz, the system provides the optimal delivery method for molecules that suffer from the drawbacks of a peak-and-valley profile, associated with multiple drug administrations per day.

For local regional and topical applications, the ViaDerm platform can enhance penetration of anti-inflammatory agents, local anesthetics and analgesics. It will also enable a much more efficient penetration of various topical drugs to their target site in various layers of the skin.

The system was successfully tested in pre-clinical and clinical studies using both small and large molecules. A recent clinical study demonstrated that therapeutic amounts of insulin were successfully delivered via the ViaDerm system – another example of transdermal drug delivery possessing the potential to replace the need of needles.

Transpharma’s technology has certainly impressed both business and pharma circles. Last month, the Lod-based company with 45 employees secured $18 million in financing led by Argonaut Private Equity and includes an additional new investor, Teva Pharmaceutical Industries Ltd., as well as TransPharma?s current investors: Pitango Venture Capital, Evergreen Partners, T2C2/Bio, Vitalife, Biomedical Investments, and TIF Ventures Pte Ltd.

“TransPharma’s accomplishments during the six years since its inception are impressive, having succeeded in developing an innovative technology and bringing its drug products to clinical trials in a short amount of time,” said Jason Martin, Managing Director, Argonaut Private Equity. ?With its strong management team, unique active transdermal delivery system and substantial market potential for its product pipeline, we believe TransPharma is well positioned as a leader in the drug delivery field.?

In addition to its investment, Israeli pharmaceutical giant Teva has also entered into a development and marketing agreement with Transpharma to co-develop five protein drug molecule products.

“We began developing the first biologic, and have done a few initial clinical studies which were successful, so we’ve passed our first milestone,” said Heffetz.

“We are very impressed by the quality and productivity of TransPharma’s team thus far in our joint development agreement,” added Teva excutive Dr. Aharon Schwartz.

According to Heffetz, Transpharma has undergone a transition since its founding.

“We’ve transformed in the last two years from being a technology-based company to a product-oriented company. We’re not just a service provider of technology, we’re also developing products,” she said.

“Our strategy is to take well know our already marketed drug molecules that have some problem with delivery and incorporate them into our delivery system. And in parallel, we’re also developing our own unique products like the osteoperosis drug delivery system.”

For Heffetz, a married mother of three, Transpharma has been the realization of her life-long ambition.

“I had been in academia for quite a while. I did my masters, PhD and post doc work at the Weizmann Institute of Science. Eventually, I decided to try the business world and found that I like it very much. I joined a diagnostics systems company called Savyion Diagnostics, and over the course of seven years worked up to the CEO position. But my dream was to found a startup, and with Transpharma, I realized that dream.”