SteadyMed Completes Clinical Validation Study of Trevyent®
April 05 2017 - 9:03AM
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."
About SteadyMed
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.
Contacts:
Marylyn Rigby
Senior Director, Investor Relations and Marketing
925-272-4999
mrigby@steadymed.com
The Ruth Group
Lee Roth
(646) 536-7012
lroth@theruthgroup.com
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