Glucagon-like peptide-1 receptor

NeuroBo to Present Latest Pre-Clinical Data on Cardiometabolic Assets, DA-1241 and DA-1726, Targeting MASH and Obesity, at Scientific Conferences in June

Retrieved on: 
Tuesday, April 30, 2024
Contract research organization, American Diabetes Association, GAN, Part, Congress, EASL, Gubra, OXM, Weight loss, GCGR, GLP1R, GPR119, Obesity, SAD, Glucagon-like peptide-1 receptor, MASH, Pharmaceutical industry

"We have completed enrollment for Part 1 of our Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).

Key Points: 
  • "We have completed enrollment for Part 1 of our Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).
  • DA-1726 has consistently shown, in our preclinical data, to sustain weight loss in diet-induced obese models by decreasing food consumption and boosting energy expenditure.
  • Both programs are progressing well, and we have been able to significantly accelerate the clinical timelines for DA-1726.
  • A member of the Dong-A ST Research Center will present pre-clinical data on DA-1726 in a poster presentation at this scientific session in Orlando, FL.

ACTG CROI Presentations Show That Semaglutide Improves Metabolic-Associated Steatotic Liver Disease Among People Living With HIV

Retrieved on: 
Tuesday, March 5, 2024
Infection, Liver, Bangladesh Technical Education Board, Metabolism, Woman, P.T, Fungal infection, NIAID, Prediabetes, CROI, Liver injury, Inflammation, Quality of life, ACTG, ALT, Weight loss, Waist, Weight, Organ dysfunction, University of Southern California, Conference, Health, Glucagon-like peptide-1 receptor, University, SLIM, ART, Triglyceride, BMI, UM1, Insulin resistance, HIV, Non-alcoholic fatty liver disease, Research, University of North Carolina, Dietary supplement

Yesterday, the SLIM LIVER poster “Effects of Semaglutide on Muscle Structure and Function in the SLIM LIVER study” was presented.

Key Points: 
  • Yesterday, the SLIM LIVER poster “Effects of Semaglutide on Muscle Structure and Function in the SLIM LIVER study” was presented.
  • Together, these presentations demonstrate that semaglutide was highly effective in improving, and in some cases, resolving completely, metabolic dysfunction-associated steatotic liver disease (MASLD, formerly known as non-alcoholic fatty liver disease) among people living with HIV.
  • SLIM LIVER is the first study evaluating semaglutide as a treatment for MASLD among people living with HIV.
  • MASLD is common among people living with HIV and likely acts synergistically with HIV to accelerate liver injury and organ dysfunction.

NeuroBo Pharmaceuticals Announces FDA Clearance of IND for a Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity

Retrieved on: 
Thursday, February 1, 2024
Weight loss, Pharmacokinetics, PD, Human, Aes, SAD, Waist, OXM, Obesity, GLP1R, BMI, IND, Safety, Food, GCGR, Glucagon-like peptide-1 receptor, Șaeș, FDA, Fasting, Weight, Body mass index, Rat, Serum, Pharmaceutical industry

CAMBRIDGE, Mass., Feb. 1, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR). The company plans to initiate a Phase 1 clinical trial, for the treatment of obesity, in the first half of this year.

Key Points: 
  • The company plans to initiate a Phase 1 clinical trial, for the treatment of obesity, in the first half of this year.
  • "Clearance of the IND for DA-1726 allows us to proceed with the Phase 1 program for this novel GLP-1 and glucagon dual receptor, a potential new treatment to address the significant obesity market," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo.
  • Secondary endpoints include the PK of DA-1726, assessed via serum concentrations over time and metabolite profiling at the highest doses of DA-1726.
  • Exploratory endpoints will include the effect of DA-1726 on metabolic parameters, cardiac parameters, fasting lipid levels, body weight, waist circumference and body mass index (BMI), among others.

NeuroBo Pharmaceuticals Submits IND Application to the FDA for a Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity

Retrieved on: 
Thursday, December 28, 2023
Waist, Food, Body mass index, Weight, Șaeș, Aes, IND, FDA, Weight loss, BMI, Fasting, Glucagon-like peptide-1 receptor, Pharmacokinetics, Investigational New Drug, Rat, Serum, PD, GCGR, Obesity, SAD, Human, Safety, Diabetes, OXM, GLP1R, Pharmaceutical industry

The IND application supports a Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) for the treatment of obesity.

Key Points: 
  • The IND application supports a Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) for the treatment of obesity.
  • "Preclinical evidence shows that DA-1726 reduced food intake while also increasing energy expenditure, which resulted in persistent weight loss in diet-induced obese mice and rats.
  • Additionally, the administration of DA-1726 resulted in similar weight reduction while consuming more food compared to tirzepatide (Mounjaro™).
  • Secondary endpoints include the PK of DA-1726, assessed via serum concentrations over time and metabolite profiling at the highest doses of DA-1726.

NeuroBo Pharmaceuticals Strengthens Board of Directors with the Appointment of James P. Tursi, M.D.

Retrieved on: 
Monday, November 6, 2023
Auxilium, GCGR, Research and Development Council of New Jersey, Research, Medical college, IND, Glucagon-like peptide-1 receptor, Physician, GPR119, GSK plc, Development, Oxyntomodulin, Endo International, Ferring Pharmaceuticals, Johns Hopkins, NASH, Medicine, Biology, Ursinus College, OXM, Obstetrics, Tursi, Drexel University College of Medicine, GLP1R, Chemistry, Fatty liver disease, Bachelor of Science in Human Biology, Johns Hopkins Hospital, Investigational New Drug, Pharmaceutical industry, Gynaecology

Dr. Tursi will also serve as a member of the Board's Nominating and Corporate Governance Committee.

Key Points: 
  • Dr. Tursi will also serve as a member of the Board's Nominating and Corporate Governance Committee.
  • "James is a proven leader, with nearly 20 years in the pharmaceutical industry and over 30 total years of medical experience," stated Andrew I. Koven, Chairman of NeuroBo's Board of Directors.
  • As such, I look forward to working closely with the NeuroBo leadership team and my fellow Directors to maximize the potential for the Company's next generation pharmaceuticals to treat cardiometabolic diseases."
  • Previously, from April 2020 until January 2022, Dr. Tursi was Chief Scientific Officer U.S. for Ferring Pharmaceuticals.

NeuroBo Pharmaceuticals Announces Acceptance of Two General Posters and One ePoster Theater Discussion of its Novel GLP1R and GCGR Dual Agonist, DA-1726, at the American Diabetes Association 83rd Scientific Sessions

Retrieved on: 
Tuesday, June 13, 2023
Abstract, Glucagon-like peptide-1 receptor, Interim, San Diego Convention Center, OXM, Weight loss, Semaglutide, Appetite, GCGR, American Diabetes Association, Balanced line, GLP1R, Rat, Regulation of tobacco by the U.S. Food and Drug Administration, IND, Oxyntomodulin, Food, Pharmaceutical industry, Computer data storage

"Having two posters selected, including one for an ePoster theater discussion, at such a prestigious scientific meeting, is a testament to the scientific community's view of the strength of the preclinical data generated, thus far, for DA-1726," stated Joe Hooker, Interim President and Chief Executive Officer of NeuroBo.

Key Points: 
  • "Having two posters selected, including one for an ePoster theater discussion, at such a prestigious scientific meeting, is a testament to the scientific community's view of the strength of the preclinical data generated, thus far, for DA-1726," stated Joe Hooker, Interim President and Chief Executive Officer of NeuroBo.
  • "As previously announced, we intend to advance DA-1726, a long acting OXM analog that binds and activates both glucagon-like peptide-1 (GLP-1) and glucagon receptors, leading to weight loss through reduced appetite and increased energy expenditure, through the IND process during the second half of this year.
  • If accepted by the U.S. Food and Drug Administration, we plan to initiate a phase 1a safety study in the first half of 2024, with a data readout expected in the second half of 2024."
  • Yuna Chae, DA-1726 Project Manager, Dong-A ST Research Center, will present a digital poster and high-level overview of the poster findings in an open discussion with a session moderator.

NeuroBo Pharmaceuticals, Inc. Appoints Pharmaceutical Industry Executive, Mark A. Glickman, to its Board of Directors

Retrieved on: 
Friday, May 12, 2023
Auxilium, Glucagon-like peptide-1 receptor, OXM, Union of Sales and Marketing Professionals, Medical device, Senior, International Management Institute, Bhubaneswar, NASH, Esperion Therapeutics, Marketing, Abbott Laboratories, State university system, Business, Head, Sale, Political science, Esperies, Business administration, Investigational New Drug, GCGR, New York University Stern School of Business, GPR119, GLP1R, Sales and operations planning, Fatty liver disease, Growth, Commercial, Therapy, IND, Oxyntomodulin, Student Senators Council of New York University, Endo International, Pharmaceutical industry, Management

"Mark is a highly accomplished pharmaceutical industry executive with more than 30 years of industry experience, including many senior leadership positions," said Andrew I. Koven, Chairman of NeuroBo's Board of Directors.

Key Points: 
  • "Mark is a highly accomplished pharmaceutical industry executive with more than 30 years of industry experience, including many senior leadership positions," said Andrew I. Koven, Chairman of NeuroBo's Board of Directors.
  • "I am excited to join the NeuroBo Board of Directors at such an important stage for the Company, especially during the advancement of the Company's two promising cardiometabolic assets," said Mr. Glickman.
  • "I look forward to working with my fellow Directors and the NeuroBo leadership team as we position the Company for long-term growth and value creation."
  • Prior to this role, he served as Chief Business Officer, Commercial of TherapeuticsMD, Inc. since June 2021.

NeuroBo Pharmaceuticals Announces FDA Clearance of IND for a Phase 2a Clinical Trial of DA-1241 for the Treatment of NASH

Retrieved on: 
Tuesday, May 2, 2023
Glucagon-like peptide-1 receptor, Interim, OXM, Obesity, NASH, Week, Alanine transaminase, Sitagliptin, Safety, Aes, Liver disease, T2DM, Inflammation, Part, Trial of the century, Șaeș, Fibrosis, Prediabetes, Patient, GCGR, Lipid metabolism, GPR119, Type, Liver, GLP1R, Chemokine, ALT, Cytokine, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Oxyntomodulin, Food, Pharmaceutical industry

BOSTON, May 2, 2023 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company on a quest to transform cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist. The company plans to initiate a two-part, Phase 2a clinical trial of DA-1241, for the treatment of nonalcoholic steatohepatitis (NASH), in the third quarter of 2023.

Key Points: 
  • The company plans to initiate a two-part, Phase 2a clinical trial of DA-1241, for the treatment of nonalcoholic steatohepatitis (NASH), in the third quarter of 2023.
  • "In Phase 1a/1b clinical studies, DA-1241 was well tolerated in both healthy volunteers and in patients with type 2 diabetes mellitus (T2DM).
  • For these reasons, we believe that the mechanism of action of DA-1241 will translate into a safe and effective treatment for NASH.
  • We are eager to initiate the two-part, Phase 2a clinical trial of DA-1241, which we expect will occur in the third quarter of this year.

AMCP Foundation Interns Delve into Oncology, Evidence Gaps, Medication Adherence in Partnership with AbbVie Inc. and Pfizer Inc.

Retrieved on: 
Thursday, November 17, 2022
Nexus, AbbVie, Pharmacy, Glucagon-like peptide-1 receptor, Medicine, Kidney, Atrial fibrillation, Student, Population health, MBA, AMCP, Safety, University, Research, Policy, Medication, Multimedia, Humana, CAE, Capital Impact Partners, University of New Mexico, Pharmacist, Academy of Managed Care Pharmacy, Providers, Operational definition, Pfizer

The goal of AMCP Foundation internships is to develop future health care leaders by exposing students to a wide variety of population health and managed care pharmacy principles.

Key Points: 
  • The goal of AMCP Foundation internships is to develop future health care leaders by exposing students to a wide variety of population health and managed care pharmacy principles.
  • Research topics included safety and effectiveness of biosimilars in the oncology landscape, postoperative atrial fibrillation and renal failure, and methods of measuring medication adherence.
  • "We are deeply grateful for the generous support of AbbVie and Pfizer, which make it possible for AMCP Foundation to train tomorrow's practitioners in research methodologies, collaboration, and business acumen."
  • By facilitating innovative research initiatives and providing educational opportunities to learn about managed care pharmacy, the AMCP Foundation invests in the future of managed care.

NeuroBo Pharmaceuticals, Inc. and Dong-A ST Co. Ltd. Announce Strategic Collaboration to License and Develop Portfolio of Dong-A's Cardio-Metabolic Therapies

Retrieved on: 
Thursday, September 15, 2022
Securities Exchange Act of 1934, Inflammation, Jeong-Dong Lee, Trial of the century, COVID-19, Fibrosis, Weight loss, Oxyntomodulin, Sale, Honigman LLP, Diabetic neuropathy, NASH, Neurodegeneration, Nasdaq, Company, Acquisition, Obesity, Form 10-K, Partnership, Achievement, U.S. Securities and Exchange Commission, Forward-looking statement, Patient, GIP, KOSE, Liver disease, OXM, Lipid metabolism, Glucagon-like peptide-1 receptor, PYY, Moelis & Company, Fatty liver disease, Private Securities Litigation Reform Act, GCGR, Security (finance), Prospectus, GLP1R, SEC, Government budget balance, Annual report, GPR119, Pharmaceutical industry

"The acquisition of these two cardiometabolic assets marks a seismic shift for NeuroBo, providing us with a highly promising, diversified pipeline with several upcoming value inflection points in the NASH and obesity space -- areas with enormous market opportunity," stated Gil Price, M.D., President and Chief Executive Officer of NeuroBo. "Through this agreement, Dong-A, one of our largest shareholders, has reaffirmed its commitment to remain a long-term strategic partner of NeuroBo. Dong-A is dedicated to our success and we are grateful it has also committed to provide continued support to facilitate the clinical development of the licensed assets. Once the transaction has closed, which is contingent upon certain closing conditions, we will be uniquely positioned to initiate a phase 2a study of DA-1241 in NASH in the first half of 2023, with data expected in the second half of 2024. We also intend to initiate a phase 1a safety study of DA-1726 in the first half of 2023, for which data is expected in the second half of 2023. We are truly excited about the prospects of NeuroBo as we transition to a cardiometabolic company across the large and growing markets of obesity and NASH."

Key Points: 
  • Under the license agreement, NeuroBo will be responsible for global development, regulatory and commercial activities other than for certain Asian-Pacific geographies.
  • Dong-A will manufacture clinical supplies and initial commercial supplies of the product at its manufacturing facility in Korea.
  • "Through this agreement, Dong-A, one of our largest shareholders, has reaffirmed its commitment to remain a long-term strategic partner of NeuroBo.
  • However, while NeuroBo may elect to update these forward-looking statements at some point in the future, NeuroBo specifically disclaims any obligation to do so.