A Thorough QTc Evaluation of the Effect of Cotadutide on Cardiac Repolarization in Healthy Participants: A Randomized, Double-blind, Placebo-controlled, 3-arm Parallel Study With a Nested Crossover Design for Positive Control With Moxifloxacin Administration

This study will investigate the effect of multiple doses of cotadutide on the cardiac activity (QTc interval) of healthy participants.

Start Date03 Jan 2023

Sponsor / Collaborator

AstraZeneca PLC

NCT05517226

/ TerminatedPhase 1

A Phase I, Parallel-group, Multi-center, Open-label, Investigation of the Pharmacokinetics, Safety and Tolerability of a Single Subcutaneous Injection of Cotadutide in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Participants With Normal Hepatic Function

This study will assess the pharmacokinetics (PK), safety, and tolerability of a single subcutaneous injection of cotadutide in participants with mild, moderate or severe hepatic impairment compared to participants with normal hepatic function.

Start Date06 Sep 2022

Sponsor / Collaborator

AstraZeneca PLC

[+1]

EUCTR2021-005484-53-AT

/ Not yet recruitingPhase 2

A Phase II Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Cotadutide in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis with Fibrosis - PROXYMO-ADVANCE

Start Date28 Jul 2022

Sponsor / Collaborator

AstraZeneca AB

100 Clinical Results associated with Cotadutide

100 Translational Medicine associated with Cotadutide

100 Patents (Medical) associated with Cotadutide

Literatures (Medical) associated with Cotadutide

01 Apr 2025·JOURNAL OF CONTROLLED RELEASE

Cotadutide reversible self-assembly based long-acting injectable depot for sustained delivery of GLP-1 glucagon receptor agonists with controlled burst release

Article

Author: Jermutus, Lutz ; Boberg, Mikael ; Grant, Iain ; Jones, Christopher ; Sundqvist, Monika ; Devalla, Durga ; Yang, Bin ; Mahmoudi, Najet ; Brookes, Stephanie ; van Rooyen, Jason ; Campbell, Andy ; Laru, Johanna ; Bak, Annette ; Sonzini, Silvia ; Paladino, Eleonora ; Dos Santos, Ana Gomes ; Weidauer, Cindy ; Gopaul, Sashi

Cotadutide (Cota) is a lipidated dual GLP-1 and Glucagon receptor agonist that was investigated for the treatment of various metabolic diseases, it is designed for once daily subcutaneous (SC) administration. Invasive daily injections can result in poor patient compliance with chronic disease, and here, we demonstrate an innovative strategy of encapsulating reversible cota self-assembled fibers within an in-situ forming depot of low molecular weight poly(lactic-co-glycolic) acid (LWPLGA) for sustained delivery GLP-1 and Glucagon receptor agonist with controlled burst release. This could be a suitable alternative to other sustained delivery strategies for fibrillating peptides. We investigated a range of cationic ions (Na⁺, Ca²⁺, Zn²⁺) and studied their influence on the secondary structure, morphology and the monomer release profile of cota fibers. Fibers forming hierarchy structures such as twisted filament and ribbons with beta sheet secondary structure resulted in better controlled burst. The subcutaneous administration of Ca²⁺ fiber/LWPLGA depot formulation in rats resulted in 60-fold reduction in maximum concentration (Cmax) compared with cota immediate release (IR) SC formulation and a prolonged plasma exposure over a month with plasma half-life extended from the 10 h observed with the cota daily formulation to 100 h. This extended-release formulation also maintains smaller peak and trough fluctuation within therapeutic window, and PK modelling of repeated dose indicates this formulation could enable a possible dose frequency of 14 days in rat with assumed therapeutic concentration (ratios of the maximum concentration and the trough concentration) C_max/C_trough window. This new long-acting injectable (LAI) method could open the door to transforming short-life peptides with sub-optimal half-life into candidates for weekly or even monthly dosing regimens, potentially leading to novel drug products with increased patient comfort.

01 Jan 2025·EUROPEAN JOURNAL OF CLINICAL INVESTIGATION

Glucagon and glucagon‐like peptide‐1 dual agonist therapy: A possible future towards fatty kidney disease

Review

Author: Zoccali, Carmine ; Ozbek, Lasin ; Kanbay, Mehmet ; Copur, Sidar ; Guldan, Mustafa ; Mallamaci, Francesca

Abstract:

Background:

Obesity is a growing epidemic affecting approximately 40% of the adult population in developed countries with major health consequences and comorbidities, including diabetes mellitus and insulin resistance, metabolically associated fatty liver disease, atherosclerotic cardiovascular and cerebrovascular diseases and chronic kidney disease. Pharmacotherapies targeting significant weight reduction may have beneficial effects on such comorbidities, though such therapeutic options are highly limited. In this narrative review, we aim to evaluate current knowledge regarding dual agonist therapies and potential implications for managing fatty kidney and chronic kidney disease.

Results and Conclusion:

Glucagon‐like peptide‐1 agonists and sodium‐glucose cotransporter‐2 inhibitors are two novel classes of glucose‐lowering medications with potential implications and beneficiary effects on renal outcomes, including estimated glomerular filtration rate, albuminuria and chronic kidney disease progression. Recently, dual agonist therapies targeting glucagon‐like peptide‐1 and glucagon receptors, namely survodutide and cotadutide, have been evaluated in managing metabolically associated fatty liver disease, a well‐established example of visceral obesity. Fatty kidney is another novel concept implicated in the pathophysiology of chronic kidney disease among patients with visceral obesity.

01 Dec 2024·KIDNEY INTERNATIONAL

A randomized phase 2b trial examined the effects of the glucagon-like peptide-1 and glucagon receptor agonist cotadutide on kidney outcomes in patients with diabetic kidney disease

Article

Author: Derwahl, Karl-Michael ; Dumas, Richard ; Selvarajah, Viknesh ; Scott, Russell ; Lecube, Albert ; Jermutus, Lutz ; Parker, Victoria E.R. ; Goldenberg, Ronald ; Robertson, Darren ; Elliott, Tom G ; Duck, Tabbatha ; Smith, Kirsten ; Heerspink, Hiddo J L ; Morales, Cristobal ; Yu, Hongtao ; Heerspink, Hiddo J.L. ; Hess, Sonja ; Khan, Anis ; Coggi, Angela ; Elliott, Tom G. ; Parker, Victoria E R ; Jolly, Simran ; Parkinson, Joanna ; Baker, John ; Chang, Yi-Ting ; Chung, H Sophia ; Hansen, Lars ; Peters, Carl ; Sánchez, José

Cotadutide is a glucagon-like peptide-1 (GLP-1) and glucagon receptor agonist that may improve kidney function in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). In this phase 2b study, patients with T2D and CKD (estimated glomerular filtration rate [eGFR] of 20 or more and under 90 mL/min per 1.73 m² and urinary albumin-to-creatinine ratio [UACR] over 50 mg/g) were randomized 1:1:1:1:1 to 26 weeks' treatment with standard of care plus subcutaneous cotadutide uptitrated to 100, 300, or 600 μg, or placebo daily (double-blind), or the GLP-1 agonist semaglutide 1 mg once weekly (open-label).The co-primary endpoints were absolute and percentage change versus placebo in UACR from baseline to the end of week 14. Among 248 randomized patients, mean age 67.1 years, 19% were female, mean eGFR was 55.3 mL/min per 1.73 m², geometric mean was UACR 205.5 mg/g (coefficient of variation 270.0), and 46.8% were receiving concomitant sodium-glucose co-transporter 2 inhibitors. Cotadutide dose-dependently reduced UACR from baseline to the end of week 14, reaching significance at 300 μg (-43.9% [95% confidence interval -54.7 to -30.6]) and 600 μg (-49.9% [-59.3 to -38.4]) versus placebo; with effects sustained at week 26. Serious adverse events were balanced across arms. Safety and tolerability of cotadutide 600 μg were comparable to semaglutide. Thus, our study shows that in patients with T2D and CKD, cotadutide significantly reduced UACR on top of standard of care with an acceptable tolerability profile, suggesting kidney protective benefits that need confirmation in a larger study.

News (Medical) associated with Cotadutide

30 Sep 2024

·www.prnewswire.com

NeuroBo Pharmaceuticals Announces Positive Top-Line Data From the SAD Part 1 of Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity

Data Revealed Favorable Safety, Tolerability and Dose-Linear Pharmacokinetics (PK) Top-Line Data Readout from the MAD Part 2 Expected in the First Quarter of 2025 Planned Phase 1 Part 3 Will Evaluate Early Proof of Concept CAMBRIDGE, Mass., Sept. 30, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced positive top-line safety, tolerability, and dose-linear pharmacokinetics (PK) data from the single ascending dose (SAD) Part 1 of its 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. In the SAD Part 1 of the Phase 1 clinical trial, a total of 45 obese, otherwise healthy participants were randomized in a double-blind, 6:3 ratio of DA-1726 or placebo. Single ascending doses were found to be safe and well tolerated, with no serious adverse events. Only 5 subjects in the DA-1726 treatment group reported adverse events (AEs) compared with 3 subjects in the placebo group. A dose-linear PK profile was observed across the investigated dose range. Additional cohorts are being added to the SAD Part 1 to explore the maximum tolerated dose. "The safety, tolerability and dose-linear PK data generated from the Part 1 SAD trial are highly encouraging and allowed for the accelerated initiation of our multiple ascending dose (MAD) study," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. "In light of the strong safety profile from the SAD Part 1 of the study, we are in the process of adding one or more cohorts to further explore the maximum tolerated dose, which will allow us to realize the full potential of DA-1726. Based on the preclinical data generated to date, as well as DA-1726's balanced activation of GLP1R and glucagon receptors, which increases energy expenditure, we continue to believe that DA-1726 may become a best-in-class obesity drug with a better tolerability profile than currently marketed GLP-1 agonists, and those now in late-stage clinical trials. We eagerly anticipate reporting top-line data from the MAD Part 2 in the first quarter of 2025, which will give us an early read on clinical efficacy. Additionally, we continue to plan Part 3 of the trial that will explore early proof of concept." The MAD Part 2 of the Phase 1 trial is a randomized, placebo-controlled, double-blind study to investigate the safety, tolerability, PK, and PD of multiple ascending doses of DA-1726 in obese, otherwise healthy subjects. Part 2 is expected to enroll approximately 36 participants, who will be randomized at the same 6:3 ratio into 4 planned cohorts, each to receive 4 weekly administrations of DA-1726 or placebo. The first patient in the MAD study was dosed ahead of schedule, in late June, as previously reported. The primary endpoint of the Phase 1 trial is to assess the safety and tolerability of DA-1726 by monitoring adverse events (AEs), serious adverse events (SAEs), treatment emergent adverse events (TEAEs) and AEs leading to treatment discontinuation. 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. For more information on this clinical trial, please visit: NCT06252220. About DA-1726 DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a GLP1R/GCGR dual agonist for the treatment of obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH) that is to be administered once weekly subcutaneously. DA-1726 acts as a dual agonist of GLP-1 receptors (GLP1R) and glucagon receptors (GCGR), leading to weight loss through reduced appetite and increased energy expenditure. DA-1726 has a well understood mechanism and, in pre-clinical mice models, resulted in improved weight loss compared to semaglutide (Wegovy®) and cotadutide (another OXM analogue). Additionally, in pre-clinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared tirzepatide (Zepbound®) and survodutide (a drug with the same MOA), while also preserving lean body mass and demonstrating improved lipid-lowering effects compared to survodutide. About NeuroBo Pharmaceuticals NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. For more information, please visit . Forward Looking Statements Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "potential", "intends", "projects", "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with NeuroBo's ability to execute on its commercial strategy; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of NeuroBo's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of NeuroBo; the cooperation of NeuroBo's contract manufacturers, clinical study partners and others involved in the development of NeuroBo's current and future product candidates; potential negative interactions between NeuroBo's product candidates and any other products with which they are combined for treatment; NeuroBo's ability to initiate and complete clinical trials on a timely basis; NeuroBo's ability to recruit subjects for its clinical trials; whether NeuroBo receives results from NeuroBo's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws or regulations; the effects of changes to NeuroBo's stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in NeuroBo's filings with the Securities and Exchange Commission, including NeuroBo's most recent Annual Report on Form 10-K. Forward-looking statements speak only as of the date when made. NeuroBo does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contacts: NeuroBo Pharmaceuticals Marshall H. Woodworth Chief Financial Officer +1-857-299-1033 [email protected] Rx Communications Group Michael Miller +1-917-633-6086 [email protected] SOURCE NeuroBo Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Clinical ResultLicense out/in

13 Aug 2024

·www.drugs.com

Enrollment Completed for the SAD Part 1 of Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity

CAMBRIDGE, Mass., Aug. 13, 2024. NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced the completion of enrollment of the single ascending dose (SAD) Part 1 of its 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. A total of 45 participants have been enrolled and randomized into one of 5 cohorts, with each cohort having been randomized in a 6:3 ratio of DA-1726 to placebo. "Completion of enrollment in Part 1 of this Phase 1 clinical trial evaluating DA-1726 for the treatment of obesity marks the achievement of yet another key milestone for NeuroBo and reflects our ongoing commitment to transforming the treatment of cardiometabolic diseases with differentiated therapies," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. "Notably, we encountered no significant issues during the SAD study, allowing us to begin the multiple ascending dose (MAD) study ahead of schedule. As previously reported, strong pre-clinical data has shown superior weight loss with DA-1726 versus semaglutide (Wegovy®) and similar weight reduction while consuming more food compared to tirzepatide (Zepbound®). Data presented at the American Diabetes Association 84th Scientific Sessions showed that DA-1726 demonstrated superior weight loss compared to survodutide, a drug with the same mechanism of action, while also demonstrating retention of relative lean body mass preservation compared to survodutide while also exhibiting superior glucose lowering. These factors lead us to believe that DA-1726 may eventually become a best-in-class obesity drug with a better tolerability profile than currently marketed GLP-1 agonists, and those now in late-stage clinical trials, based on its balanced activation of GLP1R and glucagon receptors, while increasing energy expenditure." Mr. Kim continued, "Our estimated timelines for this program remain unchanged. We expect to report top-line data from the SAD Part 1 portion of the Phase 1 clinical trial in the third quarter of this year and top-line data from the MAD Part 2 in the first quarter of 2025. Further, upon clearance of an updated Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA), we expect to dose the first patient in the planned Part 3 of the trial during the third quarter of 2025, providing an interim data readout in or around mid-2026 and issuing top-line results in the second half of 2026." The Phase 1 trial is currently designed to be a randomized, placebo-controlled, double-blind study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in obese, otherwise healthy subjects. Part 2, currently enrolling subjects, is designed as a MAD study, and is expected to enroll approximately 36 participants, who will be randomized at the same 6:3 ratio into 4 planned cohorts, each to receive 4 weekly administrations of DA-1726 or placebo. The first patient in the MAD study was dosed ahead of schedule, in late June, as previously reported. The primary endpoint of the Phase 1 trial will assess the safety and tolerability of DA-1726 by monitoring adverse events (AEs), serious adverse events (SAEs), treatment emergent adverse events (TEAEs) and AEs leading to treatment discontinuation. 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. About DA-1726 DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a GLP1R/GCGR dual agonist for the treatment of obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH) that is to be administered once weekly subcutaneously. DA-1726 acts as a dual agonist of GLP-1 receptors (GLP1R) and glucagon receptors (GCGR), leading to weight loss through reduced appetite and increased energy expenditure. DA-1726 has a well understood mechanism and, in pre-clinical mice models, resulted in improved weight loss compared to semaglutide and cotadutide (another OXM analogue). Additionally, in pre-clinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared tirzepatide and survodutide, while also preserving lean body mass and demonstrating improved lipid-lowering effects compared to survodutide. About NeuroBo Pharmaceuticals NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. Forward Looking Statements Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "potential", "intends", "projects", "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with NeuroBo's ability to execute on its commercial strategy; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of NeuroBo's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of NeuroBo; the cooperation of NeuroBo's contract manufacturers, clinical study partners and others involved in the development of NeuroBo's current and future product candidates; potential negative interactions between NeuroBo's product candidates and any other products with which they are combined for treatment; NeuroBo's ability to initiate and complete clinical trials on a timely basis; NeuroBo's ability to recruit subjects for its clinical trials; whether NeuroBo receives results from NeuroBo's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws or regulations; the effects of changes to NeuroBo's stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in NeuroBo's filings with the Securities and Exchange Commission, including NeuroBo's most recent Annual Report on Form 10-K. Forward-looking statements speak only as of the date when made. NeuroBo does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. SOURCE NeuroBo Pharmaceuticals, Inc. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Phase 1License out/in

06 Aug 2024

·www.prnewswire.com

NeuroBo Pharmaceuticals Announces Joint Research Agreement, Together with Dong-A ST and ImmunoForge to Develop a Long-Acting Once-Monthly Formulation of DA-1726 for the Treatment of Obesity

Collaboration to Leverage ImmunoForge's ELP Platform Technology Which Can Increase the Half-Life of a Drug by up to 200 Times CAMBRIDGE, Mass., Aug. 6, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that it has signed a joint research agreement, together with Dong-A ST Co. Ltd. and ImmunoForge, to develop a long-acting, once-monthly, formulation of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), utilizing ImmunoForge's long-lasting half-life extension Elastin-Like Polypeptide (ELP) platform technology. Financial terms of the agreement were not disclosed. "The signing of this research agreement, together with our collaboration partners, Dong-A ST and ImmunoForge, is a step toward potentially developing a long-acting formulation of DA-1726 which would enhance patient compliance and ease of administration for the treatment of obesity," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. "We are hopeful that ImmunoForge's ELP platform technology may enable the formulation of DA-1726, currently in Phase 1 studies, into a once-monthly injection, allowing us to overcome the current limitations associated with changing peptides, such as DA-1726, into longer-acting forms. We look forward to working closely with both Dong-A ST and ImmunoForge to bring what could be a first-in-class, once-monthly obesity treatment to market." "This agreement with Dong-A ST, one of the top pharmaceutical companies in Korea, and NeuroBo, reaffirms the potential of our ELP platform technology," added Sung-Min Ahn and Kiho Chang, Co-Chief Executive Officers of ImmunoForge. "Our patented, once-monthly, long-acting ELP platform technology has the capability to increase the half-life of a drug by up to 200 times and we look forward to exploring its application to NeuroBo's DA-1726, a highly promising approach for the treatment of obesity." About ImmunoForge ImmunoForge specializes in novel drug development with a broad pipeline, from pre-clinical through Phase 2, based on its patented Elastin-Like Polypeptide (ELP) platform technology, developed by chief technology officer, Dr. Jim Ballance, which has the ability to increase the half-life of a drug by up to 200 times. The company is currently conducting phase 2 clinical trials for Froniglutide, which has already proven to be stable and which is indicated for a range of diseases including Dermatomyositis and Polymyositis, Duchenne Muscular Dystrophy (DMD) and others. Pemziviptadil, a first-in class drug intended to treat cardiomyopathy associated with DMD and cystic fibrosis, is in preparation for the submission of a Phase 2 Investigational New Drug Application (IND) to the U.S. Food and Drug Administration. A number of the company's pipeline candidates have received FDA orphan drug designation. For more information, please visit . About DA-1726 DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a GLP1R/GCGR dual agonist for the treatment of obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH) that is to be administered once weekly subcutaneously. DA-1726 acts as a dual agonist of GLP-1 receptors (GLP1R) and glucagon receptors (GCGR), leading to weight loss through reduced appetite and increased energy expenditure. DA-1726 has a well understood mechanism and, in pre-clinical mice models, resulted in improved weight loss compared to semaglutide and cotadutide (another OXM analogue). Additionally, in pre-clinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared tirzepatide and survodutide, while also preserving lean body mass and demonstrating improved lipid-lowering effects compared to survodutide. About NeuroBo Pharmaceuticals NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and is developing DA-1726 for the treatment of obesity. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. For more information, please visit . Forward Looking Statements Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "intends", "projects", "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with NeuroBo's ability to execute on its commercial strategy; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of NeuroBo's current and future product candidates, the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of NeuroBo; the cooperation of NeuroBo's contract manufacturers, clinical study partners and others involved in the development of NeuroBo's current and future product candidates; potential negative interactions between NeuroBo's product candidates and any other products with which they are combined for treatment; NeuroBo's ability to initiate and complete clinical trials on a timely basis; NeuroBo's ability to recruit subjects for its clinical trials; whether NeuroBo receives results from NeuroBo's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws or regulations; the effects of changes to NeuroBo's stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in NeuroBo's filings with the Securities and Exchange Commission, including NeuroBo's most recent Annual Report on Form 10-K. Forward-looking statements speak only as of the date when made. NeuroBo does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contacts: NeuroBo Pharmaceuticals Marshall H. Woodworth Chief Financial Officer +1-857-299-1033 [email protected] Rx Communications Group Michael Miller +1-917-633-6086 [email protected] SOURCE NeuroBo Pharmaceuticals, Inc.

Orphan DrugPhase 1Phase 2

100 Deals associated with Cotadutide

External Link

KEGG	Wiki	ATC	Drug Bank
D11304	Cotadutide	-	DB15194

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Fibrosis	Phase 3	United States	AstraZeneca AB	12 Jul 2022
Fibrosis	Phase 3	United States	AstraZeneca Global R&D (China) Co., Ltd.	12 Jul 2022
Fibrosis	Phase 3	Japan	AstraZeneca Global R&D (China) Co., Ltd.	12 Jul 2022
Fibrosis	Phase 3	Japan	AstraZeneca AB	12 Jul 2022
Fibrosis	Phase 3	Argentina	AstraZeneca Global R&D (China) Co., Ltd.	12 Jul 2022
Fibrosis	Phase 3	Argentina	AstraZeneca AB	12 Jul 2022
Fibrosis	Phase 3	Australia	AstraZeneca Global R&D (China) Co., Ltd.	12 Jul 2022
Fibrosis	Phase 3	Australia	AstraZeneca AB	12 Jul 2022
Fibrosis	Phase 3	Austria	AstraZeneca Global R&D (China) Co., Ltd.	12 Jul 2022
Fibrosis	Phase 3	Austria	AstraZeneca AB	12 Jul 2022

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


phase 2b trial (Pubmed \| Kidney Int)	Phase 2	Diabetic Nephropathies type 2 diabetes \| chronic kidney disease	248	Cotadutide 300 μg	cvsfhukgcr(stonluxcdk) = svvqhmocdh ftevqcryrr (dkxsxxlbxd, -54.7 to -30.6)	Positive	01 Dec 2024
				Cotadutide 600 μg	cvsfhukgcr(stonluxcdk) = khpgmbtheg ftevqcryrr (dkxsxxlbxd, -59.3 to -38.4)
NCT03555994 (CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Obesity	51	Placebo (Placebo (Part A))	jeznomcyos(vvnljwhvkb) = hzttjdvfqk gumlhdaqxe (snzgqoasco, hgpuhovurf - xmeqlflwkq) View more	-	12 Nov 2024
				MEDI0382 (MEDI0382 (Part A))	jeznomcyos(vvnljwhvkb) = ydqmmycftb gumlhdaqxe (snzgqoasco, vatvbycdhx - usobbkoyls) View more
NCT04019561 (PROXYMO, Pubmed) Manual	Phase 2	Nonalcoholic Steatohepatitis \| Metabolic dysfunction-associated steatotic liver disease	74	Cotadutide 600 μg	wtodcfclcn(jpddakcqqg) = gvuxppjmsq zqnwepitrd (gkngnlleob ) View more	Positive	09 May 2024
				Cotadutide 300 μg	leodpouopi(nglqippish) = fxzdqllcjp wtlqgrfzob (hnljkhtzag ) View more
NAASO2022	Phase 2	Obesity	18	Cotadutide	akaywxzlja(yexkradwja) = dtylckyuzm ixijnnpsig (iwqhcypgsc ) View more	-	21 Nov 2022
				Placebo	akaywxzlja(yexkradwja) = npiinaazae ixijnnpsig (iwqhcypgsc ) View more
NCT03550378 (Pubmed) Manual	Phase 2	Diabetes Mellitus, Type 2 \| Chronic Kidney Diseases	41	Cotadutide	rzzpygyocj(ynwchenkle) = gxwstodoir qsxsyadytx (rmdlcyedqk ) View more	Positive	11 Apr 2022
				Placebo	rzzpygyocj(ynwchenkle) = qosimlkzcl qsxsyadytx (rmdlcyedqk ) View more
NCT03444584 (EASD2021)	Phase 2	Diabetes Mellitus, Type 2 \| Overweight Add-on	49	Cotadutide+Dapagliflozin+Metformin	djknprduod(xhmhhupktx) = acupxoxylu tvbocqohmy (gnzumzbqoo ) View more	Positive	30 Sep 2021
NCT03645421 (Pubmed) Manual	Phase 1/2	Diabetes Mellitus, Type 2 \| Overweight \| Obesity	61	cotadutide	anigmdziyw(mfmrttdkfl) = no serious adverse events. zztpeixraw (xeejgqmpkw ) View more	Positive	01 Aug 2021
				Placebo
ADA2021	Not Applicable	Type 2 diabetes mellitus in obese	-	Cotadutide	fzrkyeklst(sjdsroxvxb) = bdrziaaxcl rruxpnwemt (oklxhtzpzj, -4.85%, - 3.10%) View more	-	01 Jun 2021
				Placebo	fzrkyeklst(sjdsroxvxb) = euivhnnofx rruxpnwemt (oklxhtzpzj, -2.66%, - 0.13%) View more
ADA2021	Not Applicable	Diabetes Mellitus, Type 2 \| Diabetic Nephropathies	41	Cotadutide	vtvepimofo(qkcqzmnptt) = pzhvgjubwj tzipagihhz (mpdxppwrpl ) View more	-	01 Jun 2021
				Placebo	uydhrldidd(muiimsboud) = tmffgdhgxd igzhyrford (haszaplagk )

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