– Etrasimod CR profile designed to retain etrasimod’s rapid onset of action while further improving its potentially best-in-class, non-titrated, low intrinsic first-dose heart rate effect
– Positive topline data from Phase 1 study demonstrated significant reduction in heart rate effect, particularly during the initial 4-hour monitoring period
– Etrasimod CR program delivers rapid life-cycle management and potentially extends etrasimod’s intellectual property portfolio
SAN DIEGO, CA, USA I April 1, 2020 IArena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced positive topline data from a Phase 1 clinical study evaluating controlled-release delivery profiles (CR) for its investigational agent, etrasimod, a highly selective, once-daily, oral sphingosine 1-phosphate (S1P) receptor modulator.
Results from the study demonstrated that CR delivery enabled a greater than 75% reduction in the average heart rate effect of etrasimod during its 4-hour monitoring period, with heart rate slowing by only low single digits from baseline with no titration. At additional measurements over 24 hours, the etrasimod CR heart rate effect was reduced or similar compared to etrasimod. Of note, the rate of change in heart rate was reduced greater than 50% with etrasimod CR delivery.
On the basis of these results, Arena will embark on a product development program to rapidly develop etrasimod CR and integrate it into multiple, ongoing clinical development programs. Additionally, a recently filed provisional patent application for etrasimod CR has the potential to extend patent coverage beyond that for the composition of matter plus patent term extension.
“Etrasimod currently has a potential best-in-class profile as a rapid-acting, non-titrated oral therapy with limited first-dose heart rate effect. It is exciting that Arena’s etrasimod CR program has the potential to further differentiate this profile,” stated Preston Klassen, MD, MHS, Executive Vice President, Research and Development at Arena. “This work builds on Arena’s more than twenty-year scientific expertise in G-protein coupled receptor (GPCR) drug development and has the potential to improve etrasimod’s broad clinical utility. We intend to launch in ulcerative colitis with etrasimod and expect to move to etrasimod CR with other ongoing and future development programs across a broad range of immune-mediated inflammatory diseases.”
About Etrasimod
Etrasimod (APD334) is a next generation, once-daily, oral, highly selective sphingosine 1-phosphate (S1P) receptor modulator discovered by Arena, and designed for optimized pharmacology and engagement of S1P receptor 1, 4 and 5 which may lead to an improved efficacy and safety profile.
Etrasimod provides systemic and local effects on specific immune cell types and has the potential to treat multiple immune-mediated inflammatory diseases including ulcerative colitis, Crohn’s disease, eosinophilic esophagitis, atopic dermatitis, and alopecia areata.
Etrasimod, in any form, is an investigational compound that is not approved for any use in any country.
About Arena Pharmaceuticals
Arena Pharmaceuticals is uniquely positioned to develop best-in-disease medicines with optimized efficacy and safety for patients globally. Our drive to deliver a robust pipeline of novel, transformational medicines is grounded in two decades of world class G-protein-coupled receptor (GPCR) discovery research.
It is the breadth and depth of our portfolio, prioritization of drug development to meet unmet patient needs, strong financial health and growing, bold-thinking world-class team that gives Arena the ingredients and passion to build a sustainable, vibrant next-generation pharmaceutical company.
SOURCE: Arena Pharmaceuticals
Post Views: 208
– Etrasimod CR profile designed to retain etrasimod’s rapid onset of action while further improving its potentially best-in-class, non-titrated, low intrinsic first-dose heart rate effect
– Positive topline data from Phase 1 study demonstrated significant reduction in heart rate effect, particularly during the initial 4-hour monitoring period
– Etrasimod CR program delivers rapid life-cycle management and potentially extends etrasimod’s intellectual property portfolio
SAN DIEGO, CA, USA I April 1, 2020 IArena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced positive topline data from a Phase 1 clinical study evaluating controlled-release delivery profiles (CR) for its investigational agent, etrasimod, a highly selective, once-daily, oral sphingosine 1-phosphate (S1P) receptor modulator.
Results from the study demonstrated that CR delivery enabled a greater than 75% reduction in the average heart rate effect of etrasimod during its 4-hour monitoring period, with heart rate slowing by only low single digits from baseline with no titration. At additional measurements over 24 hours, the etrasimod CR heart rate effect was reduced or similar compared to etrasimod. Of note, the rate of change in heart rate was reduced greater than 50% with etrasimod CR delivery.
On the basis of these results, Arena will embark on a product development program to rapidly develop etrasimod CR and integrate it into multiple, ongoing clinical development programs. Additionally, a recently filed provisional patent application for etrasimod CR has the potential to extend patent coverage beyond that for the composition of matter plus patent term extension.
“Etrasimod currently has a potential best-in-class profile as a rapid-acting, non-titrated oral therapy with limited first-dose heart rate effect. It is exciting that Arena’s etrasimod CR program has the potential to further differentiate this profile,” stated Preston Klassen, MD, MHS, Executive Vice President, Research and Development at Arena. “This work builds on Arena’s more than twenty-year scientific expertise in G-protein coupled receptor (GPCR) drug development and has the potential to improve etrasimod’s broad clinical utility. We intend to launch in ulcerative colitis with etrasimod and expect to move to etrasimod CR with other ongoing and future development programs across a broad range of immune-mediated inflammatory diseases.”
About Etrasimod
Etrasimod (APD334) is a next generation, once-daily, oral, highly selective sphingosine 1-phosphate (S1P) receptor modulator discovered by Arena, and designed for optimized pharmacology and engagement of S1P receptor 1, 4 and 5 which may lead to an improved efficacy and safety profile.
Etrasimod provides systemic and local effects on specific immune cell types and has the potential to treat multiple immune-mediated inflammatory diseases including ulcerative colitis, Crohn’s disease, eosinophilic esophagitis, atopic dermatitis, and alopecia areata.
Etrasimod, in any form, is an investigational compound that is not approved for any use in any country.
About Arena Pharmaceuticals
Arena Pharmaceuticals is uniquely positioned to develop best-in-disease medicines with optimized efficacy and safety for patients globally. Our drive to deliver a robust pipeline of novel, transformational medicines is grounded in two decades of world class G-protein-coupled receptor (GPCR) discovery research.
It is the breadth and depth of our portfolio, prioritization of drug development to meet unmet patient needs, strong financial health and growing, bold-thinking world-class team that gives Arena the ingredients and passion to build a sustainable, vibrant next-generation pharmaceutical company.
SOURCE: Arena Pharmaceuticals
Post Views: 208
