KING OF PRUSSIA, PA, USA I August 6, 2014 I Trevena, Inc. (NASDAQ: TRVN), a clinical-stage pharmaceutical company and leader in the discovery and development of G protein coupled receptor (GPCR) biased ligands, today announced the initiation of the next Phase 1 trial for TRV734, a novel drug candidate in development as an orally administered treatment for moderate-to-severe acute and chronic pain. TRV734 is being developed to optimize analgesia while minimizing on-target gastrointestinal and central nervous system adverse effects through its novel biased ligand mechanism at the mu-opioid receptor. TRV734 takes advantage of the same receptor specificity mechanism as Trevena’s Phase 2 clinical compound TRV130, an intravenous mu-opioid G protein biased ligand being developed for acute postoperative pain.
The Phase 1 trial will evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of TRV734 given as a single dose and as multiple ascending doses in healthy volunteers. The aim of this study is to support Phase 2 development. Top line data are expected in the first half of 2015.
The study will be conducted in two parts and enroll a total of approximately 72 healthy volunteers. Part A will assess the safety, tolerability, PD and PK of single 125 mg doses of TRV734 in an open-label, randomized, three-period crossover study in which subjects are fasted, fed a standard meal, or fed a high-fat meal. This portion of the study is designed to explore how changes in absorption may modify the performance of TRV734 and to identify the best administration paradigm for Part B.
Part B of the trial will assess the safety, tolerability, PD and PK of multiple ascending doses of TRV734 in a double-blind, double-dummy, randomized, active- and placebo-controlled adaptive study. Oxycodone immediate release 10 mg will be used as a benchmark for a variety of pharmacodynamic measures intended to evaluate the analgesic and adverse effect profile of TRV734.
“This study builds on our recent positive Phase 1 data, and will explore dose regimens of TRV734 using a series of validated experimental measures to support subsequent Phase 2 development,” said Maxine Gowen, Ph.D., chief executive officer. “We believe that TRV734 could replace current opioid analgesics by offering improved pain relief with reduced incidence and severity of opioid-related adverse effects.”
About TRV734
The mu-opioid receptor is a well-established target for effective analgesics such as fentanyl and morphine, which are unbiased mu-opioid agonists. TRV734 is a biased ligand at the mu-opioid receptor, activating the G protein pathway, associated with analgesia, without activating the mu-opioid beta-arrestin pathway, associated with respiratory depression and constipation in preclinical studies. TRV734 takes advantage of the same novel biased ligand mechanism at the mu-opioid receptor as TRV130, the company’s Phase 2 intravenous clinical candidate which has shown promising differentiation versus morphine.
About Trevena
Trevena, Inc. is a clinical stage biopharmaceutical company that discovers, develops and intends to commercialize therapeutics that use a novel approach to target G protein coupled receptors, or GPCRs. Using its proprietary product platform, Trevena has identified and advanced three differentiated biased ligand product candidates into the clinic – TRV027 to treat acute heart failure, TRV130 to treat moderate-to-severe acute pain intravenously, and TRV734 to treat moderate-to-severe acute and chronic pain orally. Trevena also is advancing additional product candidates in its portfolio, including a preclinical program focused on central nervous system indications.
SOURCE: Trevena
Post Views: 504
KING OF PRUSSIA, PA, USA I August 6, 2014 I Trevena, Inc. (NASDAQ: TRVN), a clinical-stage pharmaceutical company and leader in the discovery and development of G protein coupled receptor (GPCR) biased ligands, today announced the initiation of the next Phase 1 trial for TRV734, a novel drug candidate in development as an orally administered treatment for moderate-to-severe acute and chronic pain. TRV734 is being developed to optimize analgesia while minimizing on-target gastrointestinal and central nervous system adverse effects through its novel biased ligand mechanism at the mu-opioid receptor. TRV734 takes advantage of the same receptor specificity mechanism as Trevena’s Phase 2 clinical compound TRV130, an intravenous mu-opioid G protein biased ligand being developed for acute postoperative pain.
The Phase 1 trial will evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of TRV734 given as a single dose and as multiple ascending doses in healthy volunteers. The aim of this study is to support Phase 2 development. Top line data are expected in the first half of 2015.
The study will be conducted in two parts and enroll a total of approximately 72 healthy volunteers. Part A will assess the safety, tolerability, PD and PK of single 125 mg doses of TRV734 in an open-label, randomized, three-period crossover study in which subjects are fasted, fed a standard meal, or fed a high-fat meal. This portion of the study is designed to explore how changes in absorption may modify the performance of TRV734 and to identify the best administration paradigm for Part B.
Part B of the trial will assess the safety, tolerability, PD and PK of multiple ascending doses of TRV734 in a double-blind, double-dummy, randomized, active- and placebo-controlled adaptive study. Oxycodone immediate release 10 mg will be used as a benchmark for a variety of pharmacodynamic measures intended to evaluate the analgesic and adverse effect profile of TRV734.
“This study builds on our recent positive Phase 1 data, and will explore dose regimens of TRV734 using a series of validated experimental measures to support subsequent Phase 2 development,” said Maxine Gowen, Ph.D., chief executive officer. “We believe that TRV734 could replace current opioid analgesics by offering improved pain relief with reduced incidence and severity of opioid-related adverse effects.”
About TRV734
The mu-opioid receptor is a well-established target for effective analgesics such as fentanyl and morphine, which are unbiased mu-opioid agonists. TRV734 is a biased ligand at the mu-opioid receptor, activating the G protein pathway, associated with analgesia, without activating the mu-opioid beta-arrestin pathway, associated with respiratory depression and constipation in preclinical studies. TRV734 takes advantage of the same novel biased ligand mechanism at the mu-opioid receptor as TRV130, the company’s Phase 2 intravenous clinical candidate which has shown promising differentiation versus morphine.
About Trevena
Trevena, Inc. is a clinical stage biopharmaceutical company that discovers, develops and intends to commercialize therapeutics that use a novel approach to target G protein coupled receptors, or GPCRs. Using its proprietary product platform, Trevena has identified and advanced three differentiated biased ligand product candidates into the clinic – TRV027 to treat acute heart failure, TRV130 to treat moderate-to-severe acute pain intravenously, and TRV734 to treat moderate-to-severe acute and chronic pain orally. Trevena also is advancing additional product candidates in its portfolio, including a preclinical program focused on central nervous system indications.
SOURCE: Trevena
Post Views: 504
