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 Sep 2024·Clinical Gastroenterology and Hepatology

Safety and Efficacy of Novel Incretin Co-agonist Cotadutide in Biopsy-proven Noncirrhotic MASH With Fibrosis

Article

Author: Sanyal, Arun J ; Shankar, Sudha S ; Carter, Debra ; Sarv, Janeli ; Jermutus, Lutz ; Daniels, Samuel J ; Sánchez, José ; Robertson, Darren ; Challis, Benjamin

BACKGROUND & AIMS:

Cotadutide, a peptide co-agonist at the glucagon-like peptide-1 (GLP-1) and glucagon (GCG) receptors, has demonstrated robust improvements in body weight, glycemia, and hepatic fat fraction (HFF) in patients living with obesity and type 2 diabetes mellitus.

METHODS:

In PROXYMO, a 19-week randomized double-blind placebo-controlled trial, the safety and efficacy of cotadutide (600 μg, 300 μg) or placebo were evaluated in 74 participants with biopsy-proven noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis. Analyses were performed using intent-to-treat and modified intent-to-treat population data.

RESULTS:

Dose- and time-dependent improvements in HFF, alanine aminotransferase (ALT), and aspartate aminotransferase (AST), markers of liver health, and metabolic parameters were observed with significant improvements after 19 weeks with 600 μg ([least squares] mean difference vs placebo, [95% confidence interval] for absolute HFF: -5.0% [-8.5 to -1.5]; ALT: -23.5 U/L [-47.1 to -1.8]; AST: -16.8 U/L [-33.0 to -0.8]). Incidences of any grade treatment-emergent adverse events (TEAEs) were 91.7%, 76.9%, and 37.5% with cotadutide 600 μg, 300 μg, and placebo, respectively. The majority were gastrointestinal, mild to moderate in severity, and generally consistent with other incretins at this stage of development. TEAEs leading to treatment discontinuation were 16.7%, 7.7%, and 4.2% with cotadutide 600 μg, 300 μg, and placebo, respectively.

CONCLUSIONS:

PROXYMO provides preliminary evidence for the safety and efficacy of GLP-1/GCG receptor co-agonism in biopsy-proven noncirrhotic MASH with fibrosis, supporting further evaluation of this mechanism in MASH.

CLINICAL TRIAL REGISTRATION NUMBER:

NCT04019561.

01 Sep 2024·CPT-Pharmacometrics & Systems Pharmacology

Exposure–response modeling for nausea incidence for cotadutide using a Markov modeling approach

Article

Author: Khan, Anis A. ; Hansen, Lars ; Flor, Armando ; Hamrén, Bengt ; Ueckert, Sebastian ; Zhou, Lina ; Yu, Hongtao ; Parker, Victoria ; Robertson, Darren ; Cheng, Jenny

Abstract:

Cotadutide is a dual glucagon‐like peptide‐1 (GLP‐1)/glucagon receptor agonist. Gastrointestinal adverse effects are known to be associated with GLP‐1 receptor agonism and can be mitigated through tolerance development via a gradual up‐titration. This analysis aimed to characterize the relationship between exposure and nausea incidence and to optimize titration schemes. The model was developed with pooled data from cotadutide‐administrated studies. Three different modeling approaches, proportional odds (PO), discrete‐time Markov, and two‐stage discrete‐time Markov models, were employed to characterize the exposure–nausea relationship. The severity of nausea was modeled as different states (non‐nausea, mild, and moderate/severe). The most appropriate model was selected to perform the covariate analysis, and the final covariate model was used to simulate the nausea event rates for various titration scenarios. The two Markov models demonstrated comparable performance and were better than the PO model. The covariate analysis was conducted with the standard Markov model for operational simplification and identified disease indications (NASH, obesity) and sex as covariates on Markov parameters. The simulations indicated that the biweekly titration with twofold dose escalation is superior to other titration schemes with a relatively low predicted nausea event rate at 600 μg (25%) and a shorter titration interval (8 weeks) to reach the therapeutic dose. The model can be utilized to optimize starting dose and titration schemes for other therapeutics in clinical trials to achieve an optimal risk–benefit balance and reach the therapeutic dose with minimal titration steps.

01 Jul 2024·Diabetes, obesity & metabolism

Dual glucagon‐like peptide‐1 and glucagon receptor agonism reduces energy intake in type 2 diabetes with obesity

Article

Author: Kennet, Jane ; Park, Adrian ; Ambery, Phil ; Evans, Mark ; Laker, Rhianna C ; Robertson, Darren ; Koulman, Albert ; Hansen, Lars ; Golubic, Rajna ; Jermutus, Lutz ; Luo, Dan ; Venables, Michelle ; Ryaboshapkina, Maria ; Parker, Victoria ; Surakala, Manasa

Abstract:

Aims:

To establish which components of energy balance mediate the clinically significant weight loss demonstrated with use of cotadutide, a glucagon‐like peptide‐1 (GLP‐1)/glucagon receptor dual agonist, in early‐phase studies.

Materials and Methods:

We conducted a phase 2a, single‐centre, randomized, placebo‐controlled trial in overweight and obese adults with type 2 diabetes. Following a 16‐day single‐blind placebo run‐in, participants were randomized 2:1 to double‐blind 42‐day subcutaneous treatment with cotadutide (100–300 μg daily) or placebo. The primary outcome was percentage weight change. Secondary outcomes included change in energy intake (EI) and energy expenditure (EE).

Results:

A total of 12 participants (63%) in the cotadutide group and seven (78%) in the placebo group completed the study. The mean (90% confidence interval [CI]) weight change was −4.0% (−4.9%, −3.1%) and −1.4% (−2.7%, −0.1%) for the cotadutide and placebo groups, respectively (p = 0.011). EI was lower with cotadutide versus placebo (−41.3% [−66.7, −15.9]; p = 0.011). Difference in EE (per kJ/kg lean body mass) for cotadutide versus placebo was 1.0% (90% CI −8.4, 10.4; p = 0.784), assessed by doubly labelled water, and −6.5% (90% CI −9.3, −3.7; p < 0.001), assessed by indirect calorimetry.

Conclusion:

Weight loss with cotadutide is primarily driven by reduced EI, with relatively small compensatory changes in EE.

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	US	AstraZeneca Global R&D (China) Co., Ltd.	12 Jul 2022
Fibrosis	Phase 3	US	AstraZeneca AB	12 Jul 2022
Fibrosis	Phase 3	JP	AstraZeneca Global R&D (China) Co., Ltd.	12 Jul 2022
Fibrosis	Phase 3	JP	AstraZeneca AB	12 Jul 2022
Fibrosis	Phase 3	AR	AstraZeneca AB	12 Jul 2022
Fibrosis	Phase 3	AR	AstraZeneca Global R&D (China) Co., Ltd.	12 Jul 2022
Fibrosis	Phase 3	AU	AstraZeneca AB	12 Jul 2022
Fibrosis	Phase 3	AU	AstraZeneca Global R&D (China) Co., Ltd.	12 Jul 2022
Fibrosis	Phase 3	AT	AstraZeneca Global R&D (China) Co., Ltd.	12 Jul 2022
Fibrosis	Phase 3	AT	AstraZeneca AB	12 Jul 2022

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03555994 (CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Obesity	51	Placebo (Placebo (Part A))	pshbwcavvl(ptvmuocdii) = fbiezksfmq tzbgraafdd (oatdgjxeki, kpxzuzfiro - vuotdkclqi) View more	-	12 Nov 2024
				MEDI0382 (MEDI0382 (Part A))	pshbwcavvl(ptvmuocdii) = blwhufbnvx tzbgraafdd (oatdgjxeki, omdqbyctmk - gckbqtzqtb) View more
NCT04019561 (PROXYMO, Pubmed) Manual	Phase 2	Nonalcoholic Steatohepatitis \| Metabolic dysfunction-associated steatotic liver disease	74	Cotadutide 600 μg	mdrmbwetoe(puswuytqxp) = jugeqqxhdl qgjskjiizv (xoxapcncth ) View more	Positive	09 May 2024
				Cotadutide 300 μg	gflkomvwzj(jfqqnntpfp) = djzfhncegh veyhowcrig (yyhdkkbbvf ) View more
NCT04515849 (EASD2023)	Phase 2	Diabetic Nephropathies	-	Cotadutide 100 µg	sbvklssbqs(mthrtdokwa) = zokhxuroxe kcffwxdtkr (pvogyypkhb, -52.5 to -23.9) View more	Positive	03 Oct 2023
				Cotadutide 300 µg	qwhdqaiwsu(rvxnzyxgrf) = nkklixfckz whcbsrliqn (vogwxlahge ) View more
NAASO2022	Phase 2	Obesity	18	Cotadutide	xkmvxdvtlt(xduuzxgscc) = xybgshvgzd xmxayygrbh (wvdrfwojoo ) View more	-	21 Nov 2022
				Placebo	xkmvxdvtlt(xduuzxgscc) = ojaklqfbus xmxayygrbh (wvdrfwojoo ) View more
NCT03550378 (Pubmed) Manual	Phase 2	Diabetes Mellitus, Type 2 \| Chronic Kidney Diseases	41	Cotadutide	wwqkmtcqce(bfvqhonjfs) = dmjeskkroc vnwxfofido (iidksscruz ) View more	Positive	11 Apr 2022
				Placebo	wwqkmtcqce(bfvqhonjfs) = wnktxvinsx vnwxfofido (iidksscruz ) View more
NCT03444584 (EASD2021)	Phase 2	Diabetes Mellitus, Type 2 \| Overweight Add-on	49	Cotadutide+Dapagliflozin+Metformin	yazfxmmrxg(farfdozfos) = bjhpqtfovx gatylwbnkk (zuizhwtsgz ) View more	Positive	30 Sep 2021
NCT03645421 (Pubmed) Manual	Phase 1/2	Diabetes Mellitus, Type 2 \| Overweight \| Obesity	61	cotadutide	iwqdbaighs(zufqmzyrkg) = no serious adverse events. qkfshpopme (jysuwajshu ) View more	Positive	01 Aug 2021
				Placebo
ADA2021	Not Applicable	Type 2 diabetes mellitus in obese	-	Cotadutide	ynknhratuk(qewvmewrrm) = mivelvwzsc ubsrkfywey (zjvmhztzqu, -4.85%, - 3.10%) View more	-	01 Jun 2021
				Placebo	ynknhratuk(qewvmewrrm) = xsxncpxfvf ubsrkfywey (zjvmhztzqu, -2.66%, - 0.13%) View more
ADA2021	Not Applicable	Diabetes Mellitus, Type 2 \| Diabetic Nephropathies	41	Cotadutide	hzgtdivzrd(edriohtzgv) = eghzqbhjth bhwoevuwyg (caaqlgdifj ) View more	-	01 Jun 2021
				Placebo	opjwxcyghk(uyzhdhpfdf) = vfuiyigrgc usorqokhxb (gwsgiiabut )

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