Study Confirms Performance of PatchPump® Technology, Further Supports Trevyent NDA Submission
SAN RAMON, Calif., April 05, 2017 (GLOBE NEWSWIRE) -- SteadyMed Ltd. (Nasdaq:STDY), a specialty pharmaceutical company focused on the development of drug product candidates to treat orphan and high-value diseases with unmet parenteral delivery needs, today announced the successful completion of a clinical study for its lead drug product candidate, Trevyent. Trevyent is a combination of the Company’s treprostinil and PatchPump prefilled, disposable infusion system that is in development for the treatment of Pulmonary Arterial Hypertension (PAH). The Company remains on track for a New Drug Application (NDA) submission for Trevyent to treat PAH, in the second quarter of 2017.
This study enrolled 60 healthy adult volunteers in an in-clinic setting, and was intended to provide clinical validation of the performance of the Trevyent product. Each subject was administered one PatchPump device containing a placebo formulation, to be used for 48 hours while subjects otherwise carried on with normal daily and nighttime activities. The objective of the study was to evaluate the essential safety and performance functions of Trevyent’s proprietary delivery system, including dose accuracy and precision, as well as tolerability for on-body application of the product. The results indicate that the PatchPump devices performed as intended in all categories of evaluation.
"We are delighted to announce the completion of this important study for Trevyent. This milestone brings us one step closer to the planned submission of the Trevyent NDA, which remains on track for the second quarter. We believe that the completion of this study, with units performing exactly as intended, confirms the utility of Trevyent over its intended 48-hour duration of single unit use," said Jonathan M. N. Rigby, President and CEO of SteadyMed. “Trevyent is a highly differentiated product that has been specifically designed to address clear unmet needs in the PAH community and we look forward to bringing Trevyent to patients suffering from PAH, if approved by the FDA, in 2018."
SteadyMed Ltd. is a specialty pharmaceutical company focused on the development of drug products to treat orphan and high value diseases with unmet parenteral delivery needs. The company's lead drug product candidate is Trevyent, a development stage drug product that combines SteadyMed's PatchPump® technology with treprostinil, a vasodilatory prostacyclin analogue to treat pulmonary arterial hypertension (PAH). SteadyMed intends to commercialize Trevyent in the U.S. and has signed an exclusive license and supply agreement with Cardiome Pharma Corp. for the commercialization of Trevyent in Europe, Canada and the Middle East. SteadyMed has offices in San Ramon, California and Rehovot, Israel. For additional information about SteadyMed please visit www.steadymed.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements about the company's ability to advance its development-stage product candidates, including Trevyent. Forward-looking statements reflect the company's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause actual results to differ materially. Risks and uncertainties include, but are not limited to, the risk that Trevyent does not demonstrate clinical superiority to existing parenteral treprostinil products, that Trevyent is not approved for commercialization by the FDA or approval is delayed by patent litigation, that Trevyent is not granted orphan drug exclusivity, the risk that drug development involves a lengthy and expensive process with uncertain outcome, that the company will not satisfy the milestone and other closing conditions to call the second tranche of its July 2016 private placement, that the company will continue to need additional funding, and that the company may be unable to raise capital when needed, which would force the company to delay, reduce or eliminate its product candidate development programs and potentially cease operations. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our Annual Report on form 10-K filed on March 29, 2017. The company does not undertake to publicly update or revise any forward-looking statements to reflect events or circumstances that may arise after the date hereof except as may be required by law.
Senior Director, Investor Relations and Marketing
The Ruth Group