Full Press Release Details
Completion of Phase 1 Study for TRV045, Novel S1P Receptor Modulator
demonstrated a favorable tolerability profile with no reported SAEs and no lymphopenia
study showed anti-inflammatory signaling, suggesting a potential disease-modifying effect of TRV045 in the treatment of epilepsy, based
on astrocyte cell culture study
anticipated once daily dosing
PA., November 9, 2022 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on
the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today
announced positive clinical data for TRV045, its selective sphingosine-1-phosphate subtype 1 (S1P1) receptor modulator. The
3-part randomized, double-blind, placebo-controlled
Phase 1 study evaluated safety, tolerability and PK in healthy volunteers.
TRV045 is being developed as a potential treatment for diabetic neuropathic pain (DNP). Through
a collaboration with the National Institutes of Health, the Company is also exploring TRV045 as a potential treatment for epilepsy.
pleased to report positive Phase 1 data on our novel S1P1 receptor modulator,
TRV045, which are consistent with its distinct mechanism of action," said Carrie Bourdow, President and CEO of Trevena.
"Planning is underway to initiate a targeted proof-of-concept study early next year, which would provide near-term data to further
validate TRV045's potential in CNS areas of interest, including epilepsy and non-opioid chronic pain."
the TRV045 Phase 1 Clinical Program
a three-part study design, examining the PK profile, safety and tolerability of orally administered TRV045 in healthy volunteers.
- Single Ascending Dose: This study phase investigated the PK profile, safety and tolerability
of single ascending doses of TRV045 or placebo. Doses were administered to 53 healthy subjects in 6 separate study cohorts, with TRV045
dosed at 5, 15, 30, 90, and 200mg.
- Food Effect: This study phase investigated the PK profile, safety and tolerability of
TRV045 administered with a high-fat meal in 3 study cohorts. The effect of food on the absorption and exposure to TRV045 was studied
in 27 subjects at doses of 30, 200 and 300mg.
- Multiple Dosing: This study phase investigated the PK profile, safety and tolerability
among a single cohort of subjects receiving multiple doses of TRV045 or placebo. A single cohort of 9 subjects were given 250mg of TRV045
daily for seven days.
from the Phase 1 study are summarized below:
an additional nonclinical study that showed TRV045 has a potential anti-inflammatory effect on astrocytes. This suggests TRV045 may play
a role as a disease-modifying treatment in epilepsy.
primary astrocytes derived from mouse brains were isolated and studied in cell culture. Astrocytes are highly prevalent glial cells that
are well recognized mediators of inflammation in the CNS. Concentrations of seventeen different cytokines and chemokines produced by
astrocytes were studied. The results demonstrated that TRV045 modulated these cytokines and chemokines, with a statistically significant
dampening of the inflammatory response of these cells.
data are potentially significant because inflammatory signals from astrocytes and other brain cells appear to play an important role
in development of seizures and the emergence of epilepsy. As a result, we believe TRV045 may have the potential to exert disease-modifying
effects in the treatment of epilepsy in humans.
Epilepsy, one of the most common neurological
diseases in the world, is a chronic disorder characterized by recurrent seizures. Epilepsy is defined as having two or more unprovoked
seizures separated by at least 24 hours or after one seizure with a high risk of more.
A seizure is a sudden surge of electrical
activity in the brain caused by complex chemical changes that occur in nerve cells. Usually, there is a balance of cells that either
encourage or stop other brain cells from sending messages. A seizure occurs when there may be too much or too little electrical activity
in the brain causing an imbalance. Seizures are a symptom of many different disorders that can affect the brain. Nearly 50 million people
suffer from epilepsy worldwide, including 3 million adults and 470,000 children in the U.S. 150,000 new cases of epilepsy are reported
in the United States each year. According to the CDC, 56% of adults living with diagnosed epilepsy continue to have seizures.
is a common complication of both type 1 and type 2 diabetes, with pain in the extremities being one of the main symptoms. Other symptoms
may include numbness, tingling, allodynia and hyperalgesia. Diabetic neuropathic pain is usually characterized as moderate to severe
in nature and can substantially affect patients' quality of life as well as their social and psychological well-being.
of people with diabetes are affected by DNP, equaling over 5 million people in the U.S. During their lifetime, approximately 50%
to 70% of diabetic patients may experience symptoms of DNP.
selective sphingosine-1-phosphate subtype 1 (S1P1) receptor modulator being developed as a potential treatment for acute and
chronic neuropathic pain secondary to diabetic peripheral neuropathy. Through a collaboration with the National Institutes of Health,
Trevena is also exploring TRV045 as a potential treatment for epilepsy.
located throughout the body, including the central nervous system, where they are believed to play a role in modulating neurotransmission
and membrane excitability.
efforts have identified a family of compounds that are highly selective for the S1P1 receptor. TRV045 reversed thermal hyperalgesia,
a measure of neuropathic pain, in nonclinical models of diabetic peripheral neuropathy and chemotherapy-induced peripheral neuropathy.
TRV045 was not associated with lymphopenia and produced no changes in blood pressure, heart rate, or respiratory function at or above
pharmacologically active doses in nonclinical studies. TRV045 is an investigational drug and has not been approved by the FDA.
is a biopharmaceutical company focused on the development and commercialization of innovative medicines for patients with CNS disorders.
The Company has one approved product in the United States, OLINVYK (oliceridine) injection, indicated in adults for the management
of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company's
novel pipeline is based on Nobel Prize winning research and includes four differentiated investigational drug candidates: TRV250 for
the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, TRV045 for diabetic neuropathic pain and epilepsy,
and TRV027 for acute respiratory distress syndrome and abnormal blood clotting in COVID-19 patients.
more information, please visit www.Trevena.com
in this press release about future expectations, plans and prospects for the Company, including statements about the Company's
strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates,
commercialization of approved drug products and other statements containing the words "anticipate," "believe,"
"estimate," "expect," "intend," "may," "might," "plan," "objective,"
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"would," "could," "should," "continue," "ongoing," or the negative of these
terms or 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 commercialization of any approved drug product, the status, timing, costs, results and interpretation of the
Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties
inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's
assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the
commercialization of OLINVYK; available funding; uncertainties related to the Company's intellectual property; uncertainties related
to the ongoing COVID-19 pandemic, 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.
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