TREVENA,INC. (NASDAQ:TRVN) Files An 8-K Regulation FD Disclosure
Item 7.01 Regulation FD.
In connection with its press release dated February21, 2017,
Trevena,Inc. (the Company) will hold a conference call and
webcast on February21, 2017. Details regarding accessing the
conference call and webcast are contained in the press release
under the heading Conference Call and Webcast. A copy of the
press release is furnished as Exhibit99.1 to this Current Report
on Form8-K and incorporated herein by reference. The information
contained in the press release furnished as Exhibit99.1 shall not
be deemed filed for purposes of Section18 of the Securities
Exchange Act of 1934, as amended (the Exchange Act), and is not
incorporated by reference into any of the Companys filings under
the Securities Act of 1933, as amended, or the Exchange Act,
whether made before or after the date hereof, except as shall be
expressly set forth by specific reference in any such filing.
Item 8.01 Other Events.
On February21, 2017, the Company announced positive top-line
results from its Phase 3 APOLLO-1 and APOLLO-2 pivotal efficacy
studies of oliceridine in moderate-to-severe acute pain following
bunionectomy and abdominoplasty, respectively. In both studies,
all dose regimens achieved their primary endpoint of
statistically greater analgesic efficacy than placebo, as
measured by responder rate.
The APOLLO-1 and APOLLO-2 studies were both Phase 3, multicenter,
randomized, double-blind, placebo- and active-controlled studies
of oliceridine. APOLLO-1 and APOLLO-2 evaluated oliceridines
efficacy in patients for 48 hours following bunionectomy and 24
hours following abdominoplasty, respectively. During the study
period, a loading dose of placebo, morphine (4 mg), or
oliceridine (1.5 mg) was administered first, and then patients
used a PCA button to dose themselves as often as every 6 minutes
with the same study drug: 1 mg morphine or 0.1 mg, 0.35 mg, or
0.5 mg oliceridine. If PCA dosing was inadequate to control pain,
patients could request supplemental study medication (0.75 mg
oliceridine or 2 mg morphine, no more than once an hour). If the
study medication regimen did not adequately manage pain, patients
could opt for an NSAID rescue analgesic. Placebo loading, demand,
and supplemental doses were volume-matched.
All endpoints were the same in both studies. Efficacy was
measured by a responder analysis, which defined a responder as a
patient who experienced at least a 30% reduction in their sum of
pain intensity difference (SPID) at the end of the treatment
period without either early discontinuation (for lack of efficacy
or safety/tolerability) or use of rescue medication.
Non-inferiority to morphine and superiority to morphine were key
secondary endpoints. Respiratory safety events were defined as
clinically relevant worsening of respiratory status (e.g., oxygen
saturation, respiratory rate, or sedation). The product of the
frequency and conditional duration of these events was reported
as respiratory safety burden, a key secondary endpoint.
Additional measures of respiratory safety included prevalence of
oxygen saturation less than 90% and prevalence of supplemental
oxygen use. Measures of gastrointestinal tolerability included
use of rescue antiemetics, vomiting, and spontaneously reported
nausea.
Results of APOLLO-1 (bunionectomy)
All three oliceridine regimens (0.1 mg, 0.35 mg, and 0.5 mg
on-demand doses) achieved the primary endpoint with statistically
superior responder rates compared to placebo at 48 hours
(p0.0001, adjusted for multiplicity).
The 0.35 mg and 0.5 mg oliceridine dose regimens demonstrated
efficacy comparable to morphine at 48 hours based on responder
rate (both doses p0.005 for non-inferiority to morphine). Both
doses were also comparable to morphine for rates of rescue
analgesic use.
Following the 1.5 mg initial loading dose, all oliceridine
regimens demonstrated rapid onset with statistically significant
efficacy by 5 minutes (p0.05).
Oliceridine exhibited a dose-related trend of improved
respiratory safety burden in all three oliceridine dose regimens
(p0.05 for the 0.1 mg regimen vs. morphine). Consistent with
this, in all dose regimens oliceridine showed dose-related trends
of reduced prevalence of oxygen desaturation (O290%) and lower
prevalence of supplemental oxygen use (p0.05 for the 0.1 mg
regimen vs. morphine for both measures).
Oliceridine exhibited a dose-related trend of less antiemetic use
compared to morphine (p0.05 for all oliceridine regimens vs.
morphine). Consistent with this, oliceridine showed dose related
trends of lower prevalence of nausea and vomiting in all three
oliceridine regimens (p0.05 for the 0.1 mg regimen vs. morphine).
Results of APOLLO-2 (abdominoplasty)
All three oliceridine dose regimens achieved the primary
endpoint with statistically superior responder rates compared
to placebo (adjusted p0.05 for the 0.1 mg regimen; adjusted
p0.001 for the 0.35 mg and 0.5 mg regimens).
The 0.35 mg and 0.5 mg oliceridine dose regimens demonstrated
efficacy comparable to morphine at 24 hours based on responder
rate (p0.05 for non-inferiority of the 0.35 mg regimen vs.
morphine). Both doses were also comparable to morphine for
rates of rescue analgesic use.
Following the 1.5 mg initial loading dose, all oliceridine
regimens demonstrated rapid onset with statistically
significant efficacy by 5 to 15 minutes (p0.05).
Oliceridine showed a dose-related trend of improved respiratory
safety burden in all three oliceridine dose regimens (p0.05 for
the 0.1 mg regimen vs. morphine). Consistent with this, for all
dose regimens oliceridine showed dose-related trends of reduced
prevalence of oxygen desaturation (O290%) and lower prevalence
of supplemental oxygen use (p0.05 for the 0.1 mg regimen vs.
morphine for both measures).
Oliceridine showed a dose-related trend of less antiemetic use
than morphine for all three oliceridine regimens (p0.05 for the
0.1 mg oliceridine regimen vs. morphine). Consistent with this,
oliceridine showed dose-related trends of lower prevalence of
nausea and vomiting (p0.05 for the 0.1 mg regimen vs. morphine
for both nausea and vomiting; p0.05 for the 0.35 mg regimen vs.
morphine for vomiting).
In both studies, oliceridine was generally well-tolerated. The
most common drug-related adverse events were nausea, vomiting,
headache, and dizziness.
Where specific p values are included under Results of APOLLO-1
(bunionectomy) and Results of APOLLO-2 (abdominoplasty) above,
statistical significance was reached on the cited measure for
the cited dose and statistical significance was not achieved
for any dose not so cited.
Separately, the Company also announced that patient enrollment
for its Phase 3 ATHENA multi-procedure safety study remains on
track, with over 400 patients treated with oliceridine and no
apparent off-target or unexpected adverse effects, in each case
as of February15, 2017. In addition, a recently completed renal
impairment study suggests that no dose adjustment will be
required in renally impaired patients, and a metabolism study
showed no evidence of active metabolites. All additional
clinical, non-clinical, and manufacturing activities remain on
track to support an NDA submission in the fourth quarter of
2017.
The Company also announced that the U.S. Food Drug
Administration has conditionally accepted OLINVO as the
proprietary brand name for oliceridine.
Risks Related to the Reported Results of
Oliceridine
The reported results of oliceridine are based on
top-line data and may ultimately differ from actual results
once additional data are received and fully
evaluated.
The reported results of oliceridine that we have publicly
disclosed, and that are discussed herein, consist of top-line
data. Top-line data are based on a preliminary analysis of
currently-available efficacy and safety data, and therefore the
reported results, findings and conclusions related to
oliceridine are subject to change following a comprehensive
review of the more extensive data that we expect to receive
related to oliceridine. Top-line data are based on important
assumptions, estimations, calculations, and information
currently available to us, and we have not received or had an
opportunity to fully and carefully evaluate all of the data
related to oliceridine. As a result, the top-line results of
oliceridine that we have reported may differ from future
results, or different conclusions or considerations may qualify
such results, once additional data have been received and fully
evaluated. In addition, third parties, including regulatory
agencies, may not accept or agree with our assumptions,
estimations, calculations or analyses or may interpret or weigh
the importance of data differently, which could impact the
value of oliceridine, the approvability or commercialization of
oliceridine, and our business in general. If the top-line data
that we have reported related to oliceridine differ from actual
results, our ability to obtain approval for, and commercialize,
our products may be harmed, which could harm our business,
financial condition, operating results or prospects.
Item 9.01. Financial Statements and
Exhibits.
(d) Exhibits
|
Number |
|
Description |
|
99.1 |
Press release dated February21, 2017 |
About TREVENA, INC. (NASDAQ:TRVN)
Trevena Inc. is a clinical-stage biopharmaceutical company. The Company discovers, develops and intends to commercialize therapeutics that use an approach to target G protein coupled receptors (GPCRs). Using its product platform, the Company has identified and advanced three differentiated product candidates: Oliceridine (TRV130), TRV027 and TRV250. Its TRV130 is a Mu-receptor G protein Pathway Selective (Mu-GPS) modulator that activates G protein. Its TRV250 is a small molecule G protein biased ligand of the d-opioid receptor in preclinical development. Its TRV734 is a small molecule Mu-GPS that it has discovered and has developed through Phase I as a first-line, orally administered compound for the treatment of moderate to severe acute and chronic pain. Its TRV027 is a peptide b-arrestin biased ligand that targets the angiotensin II type 1 receptor (AT1R). In addition to these three product candidates, the Company has identified and has completed the Phase I program for TRV734. TREVENA, INC. (NASDAQ:TRVN) Recent Trading Information
TREVENA, INC. (NASDAQ:TRVN) closed its last trading session up +0.10 at 7.13 with 550,316 shares trading hands.
