Trevena announces successful completion of Phase 1 study of TRV250 for acute migraine
June 28 2018 - 4:01PM
– Pharmacokinetics, safety, and tolerability
support advancement of TRV250 to Phase 2 –
Trevena, Inc. (NASDAQ:TRVN) announced today the successful
completion of its first-time-in-human Phase 1 study of TRV250, a
biased delta receptor agonist that the Company is developing for
the treatment of acute migraine. Preclinical data suggested
that the novel selective signaling mechanism of TRV250 might avoid
the seizure liability that has limited development of therapeutics
targeting the delta receptor. Data from this healthy
volunteer study showed safety, tolerability, and pharmacokinetics
supporting the advancement of TRV250 to Phase 2 proof of concept
evaluation in patients.
Key findings of the study were as follows:
- Dose-related increases in plasma concentrations following
subcutaneous administration of doses up to 30 mg, with rapid
absorption in the first hour and duration of exposure appropriate
for treating acute migraine;
- Subcutaneous doses at and above 9 mg achieved plasma
concentrations that were active in preclinical models of
migraine;
- Oral bioavailability similar to existing migraine medications,
supporting continued development of TRV250 in oral and/or
subcutaneous formulations;
- No observed drug-associated EEG changes, consistent with
preclinical studies in which TRV250 avoided the seizure liability
associated with previous CNS-active delta receptor agonists;
and
- No clinically significant changes in vital signs, laboratory
values, or ECG parameters, and no severe or serious adverse events
reported.
“We are pleased that TRV250 continues to show great potential
for the treatment of acute migraine,” said Maxine Gowen, President
& CEO. “Even as the treatment landscape for chronic
migraine has evolved, there remains an important unmet need for
patients who continue to suffer acute migraines and cannot achieve
relief with currently available options. With the
exposures reached in this study without associated EEG changes,
TRV250 may finally unlock the delta receptor as a therapeutic
target, and we look forward to laying the groundwork for a future
Phase 2 trial with this novel molecule.”
About the trial
This first-time-in-human study was a two part, randomized,
single-blind, placebo-controlled, single ascending dose study to
evaluate the safety, tolerability, and pharmacokinetics of
subcutaneous and oral TRV250 in healthy adult males and
females. Part A assessed single subcutaneous doses in 38
healthy subjects. Four cohorts of 9 or 10 subjects were randomized
to receive a single dose of up to 30mg TRV250 or placebo.
Part B consisted of a single cohort of 9 subjects administered
either TRV250 as a single 6 mg oral dose (either as a capsule in
the fed state or a capsule in the fasted state, n=7) or placebo (as
a capsule in the fed or fasted state, n=2).
About TRV250
TRV250 is a G protein biased ligand targeting the delta
receptor, with potential to be a first-in-class, non-narcotic
mechanism for the treatment of migraine. TRV250 also may have
utility in a range of other central nervous system
indications. As a selective delta receptor modulator, TRV250
is not expected to have the abuse and addiction liability of
medications targeting the mu opioid receptor.
About Trevena
Trevena, Inc. is a biopharmaceutical company developing
innovative therapies based on breakthrough science to benefit
patients and healthcare providers confronting serious medical
conditions. The Company has discovered four novel and
differentiated drug candidates, including oliceridine injection,
currently under review by the U.S. Food and Drug Administration for
potential approval for the management of moderate-to-severe acute
pain, TRV250 for the treatment of acute migraine, and TRV734 for
pain. The Company maintains an early stage portfolio of drug
discovery programs.
Cautionary note on forward looking
statements
Any statements in this press release about future expectations,
plans and prospects for the Company, including statements about the
Company’s strategy, future operations, clinical development of its
therapeutic candidates, plans for potential future product
candidates and other statements containing the words “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “may,” “plan,”
“predict,” “project,” “suggest,” “target,” “potential,” “will,”
“would,” “could,” “should,” “continue,” and similar expressions,
constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including: the
status, timing, costs, results and interpretation of the Company’s
clinical trials, including the results of the Company’s Phase 1
study of TRV250 and whether such results support the advance of
TRV250 into Phase 2, the potential of TRV250 for the treatment of
acute migraine or of the delta receptor as a therapeutic target,
and any plans for potential future clinical studies of this
molecule; the uncertainties inherent in conducting clinical trials;
expectations for regulatory approvals; availability of funding
sufficient for the Company’s foreseeable and unforeseeable
operating expenses and capital expenditure requirements;
uncertainties related to the Company’s intellectual property; other
matters that could affect the availability or commercial potential
of the Company’s therapeutic candidates; and other factors
discussed in the Risk Factors set forth in the Company’s Annual
Report on Form 10-K and Quarterly Reports on Form 10-Q filed with
the Securities and Exchange Commission (SEC) and in other filings
the Company makes with the SEC from time to time. In addition, the
forward-looking statements included in this press release represent
the Company’s views only as of the date hereof. The Company
anticipates that subsequent events and developments may cause the
Company’s views to change. However, while the Company may elect to
update these forward-looking statements at some point in the
future, it specifically disclaims any obligation to do so, except
as may be required by law.
Contacts
Investors: Jonathan Violin, Ph.D. Sr. Vice
President, Scientific Affairs & Investor Relations Officer
610-354-8840 x231 jviolin@trevena.com
Media: Public Relations PR@trevena.com
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