– Evaluating the safety, tolerability, and efficacy of intravenous (IV) temanogrel for cMVO in adult participants undergoing percutaneous coronary intervention (PCI)
– Currently no FDA approved therapies indicated for the treatment of cMVO
– Temanogrel was granted FDA Fast Track Designation for the treatment of cMVO
PARK CITY, UT, USA I June 8, 2021 I Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that the first participant has been randomized in a Phase 2 trial evaluating IV temanogrel, an investigational, peripherally acting, and selective 5-HT2A receptor inverse agonist, for the potential treatment of coronary microvascular obstruction (cMVO) in patients undergoing percutaneous coronary intervention (PCI).
“Despite aggressive treatment with dual anti-platelet therapies, approximately 40-60% of patients undergoing PCI for acute coronary syndrome, or ACS, fail to achieve full myocardial reperfusion,” said Andy Yong, MBBS, PhD, FRACP, FACC, Director of the Cardiac Catheterisation Lab at Concord Hospital, and Associate Professor of Medicine at the University of Sydney and Macquarie University. “cMVO increases negative cardiovascular outcomes and mortality by 2-3 fold. As there are no currently FDA-approved treatment options for patients with cMVO, the clinical advancement of a novel molecule like temanogrel for this patient population is exciting.”
The Phase 2, multi-center, randomized, placebo-controlled trial is being conducted in the US, Australia, Sweden, Netherlands, and UK, and will assess the safety, tolerability, and efficacy of two doses of intravenous temanogrel on cMVO in patients undergoing PCI. The primary endpoint is the change in Index of Microcirculatory Resistance (IMR) from baseline (prior to administration of study treatment) to post-PCI on day 1. The trial is expected to enroll 99 participants.
“The dosing of our first patient in the Phase 2 study for the potential treatment of cMVO is a significant advancement for Arena’s Cardiovascular Portfolio,” stated Paul Streck, MD Senior Vice President and Chief Medical Officer of Arena. “To date, we have seen pre-clinical and scientific validation supporting the rationale for studying the use of temanogrel in patients undergoing PCI to prevent cMVO. We expect the availability of the Phase 2 data during the second half of 2022.”
About Coronary Microvascular Obstruction
Coronary microvascular obstruction (cMVO) is a condition characterized by the failure to achieve full myocardial or microcirculatory reperfusion despite resolution of epicardial coronary occlusion and flow by a percutaneous coronary intervention (PCI). PCI results in activation of platelets and release of serotonin (5-HT), which is thought to mediate platelet aggregation and vasoconstriction.
About Temanogrel
Temanogrel (APD791) is an investigational, peripherally acting, and selective 5-HT2A receptor inverse agonist discovered by Arena, and is designed to inhibit serotonin (5-HT)-mediated amplification of platelet aggregation and vasoconstriction.
In addition to cMVO, Temanogrel is being investigated for the treatment of Raynaud’s Phenomenon secondary to Systemic Sclerosis.
Temanogrel is an investigational compound that is not approved for any use in any country.
About Arena Pharmaceuticals
ARENA Pharmaceuticals is a team with a singular purpose – deliver important medicines to patients.
In a rapidly changing global market, we work with a sense of urgency every day to understand the needs of all our stakeholders, identify bold, sometimes disruptive, ideas to get medicines to patients, and relentlessly execute until it’s done.
We are developing a richly diversified portfolio of therapeutic candidates targeting gastroenterology, dermatology and cardiology. Our pipeline includes four investigational medicines in eight indications and eleven ongoing or planned clinical trials. To fuel our growth, we are unlocking the value of our historical GPCR research with a sustainable discovery engine for broad portfolio expansion.
SOURCE: Arena Pharmaceuticals
Post Views: 210
– Evaluating the safety, tolerability, and efficacy of intravenous (IV) temanogrel for cMVO in adult participants undergoing percutaneous coronary intervention (PCI)
– Currently no FDA approved therapies indicated for the treatment of cMVO
– Temanogrel was granted FDA Fast Track Designation for the treatment of cMVO
PARK CITY, UT, USA I June 8, 2021 I Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that the first participant has been randomized in a Phase 2 trial evaluating IV temanogrel, an investigational, peripherally acting, and selective 5-HT2A receptor inverse agonist, for the potential treatment of coronary microvascular obstruction (cMVO) in patients undergoing percutaneous coronary intervention (PCI).
“Despite aggressive treatment with dual anti-platelet therapies, approximately 40-60% of patients undergoing PCI for acute coronary syndrome, or ACS, fail to achieve full myocardial reperfusion,” said Andy Yong, MBBS, PhD, FRACP, FACC, Director of the Cardiac Catheterisation Lab at Concord Hospital, and Associate Professor of Medicine at the University of Sydney and Macquarie University. “cMVO increases negative cardiovascular outcomes and mortality by 2-3 fold. As there are no currently FDA-approved treatment options for patients with cMVO, the clinical advancement of a novel molecule like temanogrel for this patient population is exciting.”
The Phase 2, multi-center, randomized, placebo-controlled trial is being conducted in the US, Australia, Sweden, Netherlands, and UK, and will assess the safety, tolerability, and efficacy of two doses of intravenous temanogrel on cMVO in patients undergoing PCI. The primary endpoint is the change in Index of Microcirculatory Resistance (IMR) from baseline (prior to administration of study treatment) to post-PCI on day 1. The trial is expected to enroll 99 participants.
“The dosing of our first patient in the Phase 2 study for the potential treatment of cMVO is a significant advancement for Arena’s Cardiovascular Portfolio,” stated Paul Streck, MD Senior Vice President and Chief Medical Officer of Arena. “To date, we have seen pre-clinical and scientific validation supporting the rationale for studying the use of temanogrel in patients undergoing PCI to prevent cMVO. We expect the availability of the Phase 2 data during the second half of 2022.”
About Coronary Microvascular Obstruction
Coronary microvascular obstruction (cMVO) is a condition characterized by the failure to achieve full myocardial or microcirculatory reperfusion despite resolution of epicardial coronary occlusion and flow by a percutaneous coronary intervention (PCI). PCI results in activation of platelets and release of serotonin (5-HT), which is thought to mediate platelet aggregation and vasoconstriction.
About Temanogrel
Temanogrel (APD791) is an investigational, peripherally acting, and selective 5-HT2A receptor inverse agonist discovered by Arena, and is designed to inhibit serotonin (5-HT)-mediated amplification of platelet aggregation and vasoconstriction.
In addition to cMVO, Temanogrel is being investigated for the treatment of Raynaud’s Phenomenon secondary to Systemic Sclerosis.
Temanogrel is an investigational compound that is not approved for any use in any country.
About Arena Pharmaceuticals
ARENA Pharmaceuticals is a team with a singular purpose – deliver important medicines to patients.
In a rapidly changing global market, we work with a sense of urgency every day to understand the needs of all our stakeholders, identify bold, sometimes disruptive, ideas to get medicines to patients, and relentlessly execute until it’s done.
We are developing a richly diversified portfolio of therapeutic candidates targeting gastroenterology, dermatology and cardiology. Our pipeline includes four investigational medicines in eight indications and eleven ongoing or planned clinical trials. To fuel our growth, we are unlocking the value of our historical GPCR research with a sustainable discovery engine for broad portfolio expansion.
SOURCE: Arena Pharmaceuticals
Post Views: 210
