GCGR

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.

Innovent Announces First Participant Dosed in a Phase 3 Clinical Study (DREAMS-2) of Mazdutide (IBI362) in Chinese Patients with Type 2 Diabetes

Retrieved on: 
Tuesday, January 10, 2023
HKEX, Liver disease, Food and Drug Administration Safety and Innovation Act, Type 2 diabetes, Drug, SGLT2, Gout, Glycated hemoglobin, Trial of the century, Moyamoya disease, GCGR, Patient, Metformin, Attention, Ophthalmology, ClinicalTrials.gov, Hypoglycemia, Safety, Obesity, Diabetes, Blood pressure, Hyperlipidemia, Hospital, Pharmaceutical industry, Beijing Hospital of Traditional Chinese Medicine

In a phase 2 clinical study of mazdutide in Chinese patients with type 2 diabetes (ClinicalTrials.gov, NCT04965506), mazdutide was well tolerated and the overall safety profile was similar to other GLP-1 class drugs.

Key Points: 
  • In a phase 2 clinical study of mazdutide in Chinese patients with type 2 diabetes (ClinicalTrials.gov, NCT04965506), mazdutide was well tolerated and the overall safety profile was similar to other GLP-1 class drugs.
  • In the study, mazdutide reduced blood pressure, blood lipids and liver enzyme levels, offering metabolic benefits to subjects.
  • The phase 2 clinical study in Chinese patients with type 2 diabetes showed significant glucose-lowering efficacy of mazdutide, and it also showed the potential superiority of mazdutide to dulaglutide in weight-loss efficacy.
  • As a promising example of GLP-1 dual-target drugs, mazdutide has been extensively researched and developed in Chinese patients with type 2 diabetes.

Zealand Pharma Announces Oral Presentation of Phase 2 Data for BI 456906 at the 58th Annual Meeting of the European Association for the Study of Diabetes (EASD)

Retrieved on: 
Wednesday, September 21, 2022
Fatty liver disease, Safety, COVID-19, Advertising, MD, Vomiting, NASH, Week, Overweight, GCG, Obesity, Intellectual property, Private Securities Litigation Reform Act, Metformin, Glucagon, Patient, BI, 2021 Essex County Council election, Abstract, Nasdaq, Liver, Science, Pharmacology, European Association for the Study of Diabetes, GCGR, Research, EASD, Boehringer Ingelheim, Association, Nausea, Boehringer, Incretin, T2D, Failure, Human, Fine chemical, Pharmaceutical industry, Vaccine, Glycated hemoglobin, Zealand Pharma

Preclinical data on BI 456906 will also be presented at the EASD annual meeting.

Key Points: 
  • Preclinical data on BI 456906 will also be presented at the EASD annual meeting.
  • BI 456906 is being developed by Boehringer Ingelheim and was co-invented with Zealand Pharma.
  • Most adverse events were reported during the dose-escalation phase of the trial, and therefore slower escalation schemes may mitigate the frequency.
  • Different doses of BI 456906 were escalated every 12 weeks to ensure that 10 weeks were spent on a maintenance dose.

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.

Zealand Pharma Announces Multiple Presentations at the 82nd Annual American Diabetes Association Scientific Sessions, Including Initial Clinical Data on GLP-1/GLP-2 Dual Agonist Dapiglutide

Retrieved on: 
Tuesday, May 31, 2022
Well, People, Oxyntomodulin, Safe Medical Device Amendments of 1990, Private Securities Litigation Reform Act, IIT, Fibrillation, Nasdaq, American Diabetes Association, 2021 Essex County Council election, Hypoglycemia, Patient, Drug nomenclature, Obesity, DK, Treatment, Lists of diseases, Animal Health, Time, Half-life, Human, COVID-19, Failure, GCGR, Research, ADA, Glucagon-like peptide-1 receptor, Plasma, Peptide, Intellectual property, Public, CDT, Safety, Biomarker, Solubility, Steno Diabetes Center, Advertising, Boehringer Ingelheim, Animal, Randomness, Weight loss, AstraZeneca, Zealand Pharma, Pharmaceutical industry, Fine chemical, Flour

Zealand Pharma Announces Multiple Presentations at the 82nd Annual American Diabetes Association Scientific Sessions, Including Initial Clinical Data on GLP-1/GLP-2 Dual Agonist Dapiglutide

Key Points: 
  • Zealand Pharma Announces Multiple Presentations at the 82nd Annual American Diabetes Association Scientific Sessions, Including Initial Clinical Data on GLP-1/GLP-2 Dual Agonist Dapiglutide
    Copenhagen, DK and Boston, MA, U.S. May 31, 2022 Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no.
  • Zealand Pharma has two oral presentations, including Phase 1 clinical data demonstrating significant weight loss with Zealands dapiglutide, a novel GLP1/GLP2 dual agonist and preclinical data on the antidiabetic potential of the companys long-acting amylin analogue ZP8396.
  • Two additional abstracts include study results from a Zealand supported, investigator-initiated trial (IIT) with dasiglucagon led by investigators from the Steno Diabetes Center.
  • Additionally, Boehringer Ingelheim will have a poster presentation with preclinical data on the dual glucagon and glucagon-like peptide-1 receptor (GCGR/GLP-1R) agonist BI 456906 co-invented with Zealand Pharma, for the treatment of obesity.