Effect of polyethylene glycol loxenatide treatment on body weight in patients with type 2 diabetes with different body mass index: a retrospective cohort study

Start Date30 Jul 2024

Sponsor / Collaborator

Shanghai Tongji Hospital

ChiCTR2400086699 / SuspendedNot ApplicableIIT

Efficacy and safety of polyethylene glycol loxenatide in combination with basal insulin in patients with type 2 diabetes mellitus: a retrospective cohort study

Start Date15 Jul 2024

Sponsor / Collaborator

The Third Xiangya Hospital of Central South University

ChiCTR2300079158 / RecruitingNot ApplicableIIT

Integration of Metabolomics and Multi-Modal fMRI Functional Imaging Techniques to Investigate the Role and Mechanisms of GLP-1 Receptor Agonist PEG-Loxenatide in Alleviating Early Damage in Diabetic Cardiomyopathy

Start Date01 Jan 2024

Sponsor / Collaborator-

100 Clinical Results associated with PEG-Loxenatide

100 Translational Medicine associated with PEG-Loxenatide

100 Patents (Medical) associated with PEG-Loxenatide

Literatures (Medical) associated with PEG-Loxenatide

01 Mar 2024·European review for medical and pharmacological sciences

Is polyethylene glycol loxenatide 100 μg the preferred glucagon-like peptide-1 receptor agonist for type 2 diabetes mellitus? A meta-analysis and trial sequential analysis.

Article

Author: Yang, X-Y ; Yu, R ; Liu, P ; Hu, G ; Jiang, P-F ; Yin, S ; Yu, Y-F ; Tong, K-K

OBJECTIVEThis study aimed to systematically evaluate the efficacy, safety and optimal dose of polyethylene glycol loxenatide (PEX168) for treating type 2 diabetes mellitus (T2DM).MATERIALS AND METHODSClinical trials of PEX168 for T2DM were identified in 8 databases, with a build time limit of January 2023. Included studies were subjected to meta-analysis and trial sequential analysis (TSA).RESULTSOn the efficacy endpoint, the meta-analysis showed that PEX168 100 μg significantly reduced 0.86% glycated hemoglobin type A1c (HbA1c) (MD -0.86, 95% CI -1.02 - -0.70, p<0.00001), 1.11 mmol/L fasting plasma glucose (FPG) (MD -1.11, 95% CI -1.49 - -0.74, p<0.00001) and 1.91 mmol/L 2h postprandial glucose (PPG) (MD -1.91, 95% CI -3.35 - -0.46, p=0.01) compared with placebo. The TSA showed that all these benefits were conclusive. On safety endpoints, total adverse events (AEs), gastrointestinal (GI) AEs, serious AEs, and hypoglycemia were comparable to placebo for PEX168 100 μg (p>0.05). In the dose comparison, the HbA1c, FPG, and 2h PPG of PEX168 200 μg were comparable to 100 μg (p>0.05), while GI AEs were significantly higher than 100 μg (RR=2.84, 95% CI 1.64-4.93, p=0.0002).CONCLUSIONSPEX168 100 μg can significantly lower blood glucose and does not increase the risk of total AEs, GI AEs, and hypoglycemia, which may be a preferred glucagon-like peptide-1 receptor agonist for type 2 diabetes mellitus.

01 Dec 2023·Journal of the College of Physicians and Surgeons Pakistan

Clinical Efficacy of Polyethylene Glycol Loxenatide in the Treatment of Obese or Overweight Patients with Type 2 Diabetes Mellitus

Article

Author: Yao, Mingyan ; Song, Xixi ; Guo, Shuqin ; Yin, Fei ; Li, Zhihong ; Li, Ruixue

OBJECTIVETo determine the clinical efficacy of Polyethylene Glycol Loxenatide in the treatment of obese or overweight Type 2 Diabetes mellitus (T2DM) patients.STUDY DESIGNA randomised-controlled trial. Place and Duration of the Study: Department of Endocrinology, Baoding No. 1 Central Hospital, Hebei, China, from January 2020 to January 2022.METHODOLOGYOne hundred overweight and obese patients who were diagnosed with T2DM were prospectively included. They were randomly divided into two groups, with 50 cases in each group. The control group was given oral metformin + subcutaneous insulin injection. The combined treatment group was also given Polyethylene Glycol Loxenatide in addition to the control treatment. The duration of treatment was 6 months for both groups. The clinical efficacy of the two group treatments was compared. The height, body mass, weight index (body mass index (BMI)), total cholesterol (TC), 2-h postprandial blood glucose (2hPBG), high-density lipoprotein cholesterol, fasting insulin (FINS), lipids (triglycerides (TG), low-density lipoprotein cholesterol, homeostasis model assessment of insulin resistance (HOMA-IR) levels, fasting blood glucose (FPG), and glycosylated haemoglobin (HbAlc) were evaluated before and 6 months after the treatment. In addition, any adverse reactions in the two groups were observed.RESULTSThe overall effective rate of clinical therapy was 92% (46/50) in the combined treatment group, which was higher than that of the control group (76%, 38/50, p = 0.029). The weight and BMI levels of the combined treatment group became considerably lower than those of the control group (weight p = 0.004; BMI p <0.001), and the levels of FPG, 2hPBG, FINS, HbAlc and HOMA-IR (all p = <0.001), and the TG and TC values decreased in both groups (TG p = 0.001; TC p = 0.016).CONCLUSIONPEG Loxenatide considerably affects obese and overweight T2DM patients. With no noticeable adverse reactions, this drug is highly recommended for application and clinical promotion.KEY WORDSPolyethylene Glycol Loxenatide, Type 2 Diabetes mellitus, Obesity, Overweight, Clinical efficacy.

01 Nov 2023·Journal of Biochemical and Molecular Toxicology

Loxenatide attenuates ROS‐mediated vascular endothelial progenitor cell damage and mitochondrial dysfunction via SIRT3/Foxo3 signaling pathway

Article

Author: Yuan, Junfang ; Wang, Defeng ; Wang, Yuzhong ; Wang, Ning ; Yan, Han

AbstractDiabetes mellitus (DM), becomes a main public health issue worldwide due to the rapid increase in DM patient numbers. The dysfunction of endothelial progenitor cells (EPCs) in DM patients plays a critical role in endothelial repair and the progression of DM‐related vascular complications. Loxenatide is an a glucagon‐like peptide 1 receptor agonist, which is used to control glycemic in type 2 diabetes patients. However, the role of Loxenatide in EPCs remains to be investigated. EPCs were isolated, characterized, and treated with Loxenatide, high‐glucose, or 3‐TYP. quantitative real‐time polymerase chain reaction, flow cytometry, western blot, and cell counting kit‐8 assay were employed to validate the expression of gene and protein expressions and cell viability, respectively. Application of Seahorse XFp to measure oxygen consumption and mitochondrial membrane potential (MMP) were measured by Seahorse XFp and MMP assay. Loxenatide attenuated high‐glucose‐induced reactive oxygen species (ROS) production and mitochondrial‐dependent apoptosis of EPCs in a concentration‐dependent manner. The EPC mitochondrial respiration dysfunction induced by high glucose was also repressed by the loxenatide treatment. The protection effect of Loxenatide on EPCs against high‐glucose was applied by activating the sirtuin 3 (SIRT3)/Foxo3 signaling pathway. We demonstrated the regulatory role of Loxenatide in mitochondrial dysfunction and apoptosis of EPCs. We elucidated that Loxenatide protects EPC from high‐glucose‐induced apoptosis via ROS‐mediated mitochondrial pathway through the SIRT3/Foxo3 signing pathway. This may provide a new therapeutical target for the treatment of DM‐related vascular complications.

News (Medical) associated with PEG-Loxenatide

15 Nov 2022

·www.prnewswire.com

Biotheus has entered into a license and collaboration agreement with Hansoh Pharma for its EGFR/MET bispecific antibody in the Greater China territory

ZHUHAI, China, Nov. 14, 2022 /PRNewswire/ -- Biotheus Inc., a clinical-stage biotech company focused on the discovery and development of biologics for oncology and inflammatory diseases, announced today that they have entered into a collaboration agreement with Hansoh Pharmaceuticals, for Biotheus' EGFR/MET bispecific antibody (also known as PM1080) in Greater China, including Mainland China, Hong Kong, Macao and Taiwan. Under the terms of the agreement, Hansoh will be granted by Biotheus the exclusive rights to develop, commercialize and manufacture PM1080 for the treatment of cancer, and shall assume all the costs accordingly in the territory. In return, Biotheus will receive 50 million CNY and is entitled to receive up to ~1.4 billion CNY for future development, regulatory and commercialization milestones, plus tiered royalty payments based on net sales. "We are delighted to enter into a partnership with Biotheus." Said Ms. Yun Sun, Managing Director of the Board at Hansoh. "EGFR/MET bispecific antibodies are an instrumental therapeutic option for non-small cell lung cancer and other cancer indications; PM1080, based on its outstanding efficacy, safety and PK profiles in preclinical studies, has best-in-class potential for treating cancer, either alone or in combination with Hansoh's almonertinib. Through this partnership, we believe that we will bring forth rapidly a better therapeutic option to Chinese cancer patients, by utilizing our rich experience and capabilities in the development and commercialization of oncological drugs." "We really appreciate Hansoh's trust and confidence in us.", said Xiaolin Liu, Co-founder, Chairman and Chief Executive Officer of Biotheus. "Hansoh is one of the leading oncology pharmaceutical companies in China and this collaboration spurs the synergy between Hansoh's strong development and commercialization capabilities with our rich R&D expertise at Biotheus. The partnership will expedite the development and commercialization of PM1080 in Greater China. Biotheus has robust R&D platforms with 10 programs currently undergoing phase I or II clinical development. We are proud of our current accomplishments within four years of founding Biotheus and will continue our commitment to discover innovative drugs to benefit patients." About PM1080 PM1080 is an EGFR/MET bispecific antibody under development at Biotheus, who owns global rights to the asset. PM1080 is currently undergoing GLP toxicity studies. Previous preclinical data has shown that PM1080 is safe and efficacious, either alone or in combination with other anti-cancer agents, including EGFR TKIs. About Biotheus Inc. Biotheus Inc. is a clinical-stage biotech company established in 2018 and is committed to the development and commercialization of novel antibodies and cell therapies, to address the unmet medical needs of patients with oncology and inflammatory diseases worldwide. Since its inception, Biotheus has established multiple top-caliber platforms for antibody discovery and a propriety cell therapy that delivers T cell engagers into the tumor microenvironment to destroy tumor cells. With a well-seasoned development team, Biotheus has built up a robust pipeline inclusive of 10 programs at different stages of clinical development. For more information about Biotheus, please visit: . About Hansoh Pharmaceuticals Hansoh Pharma (3692.HK), one of the largest biopharmaceutical companies in Greater China and in China, is committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders. Hansoh Pharma is supported by over 10,000 dedicated employees in China and the United States. Founded in 1995, Hansoh has fully integrated research and development, manufacturing, and commercial capabilities, supporting leading positions in oncology, central nervous system (CNS) disorders, infectious diseases, gastrointestinal disorders, diabetes, autoimmune diseases, and other main therapeutic areas in China. With the support of over 1,400 highly skilled R&D professionals, Hansoh has successfully developed multiple internally discovered drug candidates into NMPA-approved innovative medicines, including Morinidazole (Mailingda, 迈灵达), a third-generation nitroimidazole antibiotic; PEG-Loxenatide (Fulaimei, 孚来美), the first once-weekly long-acting GLP-1 analogue discovered and developed in China for the treatment of diabetes; Flumatinib (Xinfu, 昕福), a second-generation BCR-ABL inhibitor for frontline treatment of chronic myeloid leukemia (CML); Almonertinib (Ameile, 阿美乐), a third-generation EGFR inhibitor for the treatment of NSCLC with EGFR mutations; and Tenofovir Amibufenamide (恒沐), the first second-generation oral anti-HBV drug developed in China. Through collaboration and partnership, NMPA has granted approval to Inebilizumab (Xinyue, 昕越), a humanized anti-CD19 monoclonal antibody, as a treatment for patients with neuromyelitis optica spectrum disorder (NMOSD). For more information, please visit . SOURCE Biotheus Inc.

License out/inDrug ApprovalImmunotherapy

26 Sep 2022

·www.biospace.com

KiOmed Pharma and Hansoh Pharma Announce License Agreement for KiOmedinevsOne in China’s Mainland, Macau and Taiwan

- KiOmedinevsOne is a non-animal sourced chitosan injection that has been launched in Europe for the treatment of knee osteoarthritis. - KiOmed Pharma is eligible to receive upfront fee and milestone payments of up to €66 million plus double-digit royalties on future product sales. - Hansoh Pharma will be responsible for development, regulatory approval, and commercialization of KiOmedinevsOne in the territory. HERSTAL, Belgium & SHANGHAI--(BUSINESS WIRE)-- KiOmed Pharma, a Belgian biotechnology company with a focus on the development, manufacture and distribution of safe and effective medical devices based on a medical-grade highly pure natural chitosan-derivative, and Hansoh Pharmaceutical Group Company Limited (SEHK: 3692), a leading biopharmaceutical company in Asia, today announced a license agreement for the development and commercialization of KiOmedinevsOne, a carboxymethyl chitosan injection that has been launched in Europe for the treatment of knee osteoarthritis, in China’s mainland, Macau and Taiwan (the territory). Under the terms of the agreement, KiOmed will receive an upfront payment and will be eligible to receive development, regulatory and commercial milestones of up to € 66 million, as well as tiered royalties on future product sales. Hansoh will receive exclusive rights to develop and commercialize KiOmedinevsOne and its future extensions in the territory. KiOmed retains the right to develop and commercialize KiOmedinevsOne in all other global markets. Osteoarthritis is a progressive and disabling disease affecting about 250 million people worldwide. According to a recent epidemiology report, the prevalence of knee osteoarthritis in China is 8.1%. As the population in China is aging rapidly, disease burden caused by knee osteoarthritis continues to rise while safe and effective treatment options are still lacking. “We are very excited to partner with Hansoh Pharma, one of the largest biopharmaceutical entities in Greater China. We believe that with Hansoh’s impactful presence in China, their support will be essential to bring this long-acting treatment to the large population of patients suffering from osteoarthritis in China,” said Mr. François Blondel, Founder and Executive Chairman of the Board of KiOmed Pharma. “We launched KiOmedinevsOne last year in several regions of Europe, and the feedback we continue to receive from osteoarthritis patients and physicians is great. With just one single injection to the knee, it can provide symptoms relief including pain, stiffness, and function improvement for more than 6-month. It is the world-first next generation non-animal sourced chitosan injection with a potential safety advantage over animal-sourced chitosan,” added Dr. Houtaï Choumane, CEO and Managing Director of KiOmed. “KiOmed is a leader and an expert in developing natural chitosan products to fulfill unmet medical needs in different spaces. Osteoarthritis negatively impacts an individual’s quality of life and creates a large burden for the patients and their families. We are very glad to see KiOmed’s product (KiOmedinevsOne) will help to solve this problem,” said Eliza Sun, Executive Director of the Board of Hansoh Pharma. “We are also very excited to partner with them and bring this unique product to much needed patients in China.” About KiOmedinevsOne KiOmedinevsOne is a new generation single injection for the treatment of knee osteoarthritis based on world-first exclusive animal free KiOmedine® CM-Chitosan. KiOmedine® CM-Chitosan is a highly purified polysaccharide derived from Agaricus Bisporus (button mushroom) and a patented technology made in Belgium, resulting from years of research and innovation. Different from hyaluronic acid, KiOmedinevsOne has dual mechanism of action to tackle osteoarthritis discomfort and other symptoms by reducing oxidative stress and enhancing joint lubrication. Clinical studies have shown that after a single injection of KiOmedinevsOne, significant pain reduction was observed within 2 weeks and the WOMAC pain score was reduced by 66%, with a long-lasting osteoarthritis symptom reduction for at least 6 months. KiOmedinevsOne is a regulated health product which bears the CE mark under this regulation. It has been launched in Europe in 2021. About KiOmed Pharma Based in Belgium, KiOmed Pharma has a history of innovation and expertise in exclusive natural chitosan chemistry. The company develops a unique pipeline of medical devices that address unmet medical needs in high impact pathologies and major social burdens such as osteoarthritis, skin aging and ophthalmology. KiOmed Pharma's innovative pipeline is based on a solid building block exclusive technology: KiOmedine®, a medical-grade highly pure natural chitosan-derivative. For more information, please visit . About Hansoh Pharmaceutical Group Hansoh Pharma (3692.HK), one of the largest biopharmaceutical companies in China, is committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders. Founded in 1995, Hansoh has fully integrated research and development, manufacturing, and commercial capabilities, supporting leading positions in oncology, central nervous system (CNS) disorders, infectious diseases, gastrointestinal disorders, diabetes, autoimmune diseases, and other main therapeutic areas in China. With the support of over 1,400 highly skilled R&D professionals, Hansoh has successfully developed multiple internally discovered drug candidates into NMPA-approved innovative medicines, including Morinidazole (Mailingda®, 迈灵达®), a third-generation nitroimidazole antibiotic; PEG-Loxenatide (Fulaimei®, 孚来美®), the first once-weekly long-acting GLP-1 analogue discovered and developed in China for the treatment of diabetes; Flumatinib (Xinfu®, 昕福®), a second-generation BCR-ABL inhibitor for frontline treatment of chronic myeloid leukemia (CML); Almonertinib (Ameile®, 阿美乐®), a third-generation EGFR inhibitor for the treatment of NSCLC with EGFR mutations; and Tenofovir Amibufenamide (恒沐®), the first second-generation oral anti-HBV drug developed in China. Through collaboration and partnership, NMPA has granted approval to Inebilizumab (Xinyue®, 昕越®), a humanized anti-CD19 monoclonal antibody, as a treatment for patients with neuromyelitis optica spectrum disorder (NMOSD). For more information, please visit .

CollaborateAntibody

100 Deals associated with PEG-Loxenatide

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KEGG	Wiki	ATC	Drug Bank
-	-	A10B	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	CN	Jiangsu Hansoh Pharmaceutical Co. Ltd.	05 May 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nephrosis	Phase 1	CN	Jiangsu Hansoh Pharmaceutical Co. Ltd.	07 Jul 2015
Renal Insufficiency	Phase 1	CN	Jiangsu Hansoh Pharmaceutical Co. Ltd.	07 Jul 2015
Diabetes Mellitus, Type 2	Preclinical	-	Jiangsu Hansoh Pharmaceutical Co. Ltd.	23 Mar 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ChiCTR2200057800 (Pubmed)	Phase 4	Diabetes Mellitus, Type 2 \| Overweight \| Obesity	156	PEG-Loxe 0.3 mg	(fbrdbcepio) = ckduyiqahk nizgkvgxug (qdvbdgtzbv )	-	01 Jan 2023
				Metformin 1500 mg	(fbrdbcepio) = ldaaorvrdb nizgkvgxug (qdvbdgtzbv )
NCT02467790 (Pubmed \| Br J Clin Pharmacol) Manual	Phase 1	Renal Insufficiency	23	Polyethylene glycol loxenatide	(wjbqyxtnms) = niiujegsyd gipxoonqer (cwqkwndctr ) View more	Positive	01 Dec 2019
NCT02477969 (phase 3b, EASD2019)	Phase 3	Diabetes Mellitus, Type 2	533	Metformin+Placebo	mihnvvohxl(vbthgvqfns) = The gastrointestinal reactions were mild during the entire study gvfafvgdnm (tnebdflzox ) View more	Positive	19 Sep 2019
				Metformin+PEX168 100 µg
NCT02477865 (PEX168, EASD2019)	Phase 3	Diabetes Mellitus, Type 2	406	PEX168 100 µg	(tkqzvtssoy) = No serious adverse events (SAEs) occurred in each group during the trial iinjljplug (styzyqgduq ) View more	Positive	17 Sep 2019
				PEX168 200 µg
NCT02467790 (not available, EASD2019)	Phase 1	Renal Insufficiency	-	PEX168 200 μg	(ogmaqavcii) = Most adverse events were mild gastrointestinal disorders, with only one serious adverse event was observed ohhapxozop (wxysbstlzj ) View more	Positive	17 Sep 2019
				Polyethylene glycol loxenatide (PEX168)

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