[{"orgOrder":0,"company":"I-Mab Biopharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"China NMPA Accepts IND Application for Eftansomatropin Pivotal Trial in Pediatric Patients with Growth Hormone Deficiency","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Peptide","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Peptide","graph2":"I-Mab Biopharma"},{"orgOrder":0,"company":"I-Mab Biopharma","sponsor":"Genexine","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"I-Mab Receives China CDE Approval to Initiate Phase 3 Clinical Trial of Eftansomatropin in Pediatric Patients with Growth Hormone Deficiency","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Peptide","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Peptide","graph2":"I-Mab Biopharma"},{"orgOrder":0,"company":"Innovent Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Innovent Begins Patient Dosing in phase 2 Trial of IBI362 to Treat Type 2 Diabetes in China","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Peptide","productStatus":"New Molecular Entity","date":"September 2021","url1":"","url2":"","graph1":"Peptide","graph2":"Innovent Biologics"},{"orgOrder":0,"company":"Innovent Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Innovent Releases Results of a Phase 1 Clinical Study of IBI362, a Dual Glucagon-like Peptide-1 and Glucagon Receptor Agonist in Chinese Patients with Type 2 Diabetes at the International Diabetes Federation Congress 2021","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Peptide","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Peptide","graph2":"Innovent Biologics"},{"orgOrder":0,"company":"Sciwind","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sciwind Biosciences Completes Enrollment in Phase 2 Clinical Trial of XW003 in Type 2 Diabetes Patients","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Peptide","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Peptide","graph2":"Sciwind"},{"orgOrder":0,"company":"HighTide Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HighTide Therapeutics Announces First Patient Dosed in Phase 2 Clinical Study Evaluating HTD1801 in Type 2 Diabetes Mellitus","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"HighTide Therapeutics"},{"orgOrder":0,"company":"Innovent Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Innovent Announces Phase 1b Study Results of Mazdutide (IBI362) in Chinese Patients with Type 2 Diabetes Published in Nature Communications","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Peptide","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Peptide","graph2":"Innovent Biologics"},{"orgOrder":0,"company":"Sciwind","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sciwind Biosciences Announces Positive Topline Results from 20-week Phase 2 Clinical Trial of XW003 (Ecnoglutide), a novel long-lasting GLP-1 analogue, in Adult Patients with Type 2 Diabetes in China","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Peptide","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Peptide","graph2":"Sciwind"},{"orgOrder":0,"company":"Sciwind","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sciwind Biosciences Reports Positive Interim Results from Phase 1c\/2a Clinical Trial of XW003 (Ecnoglutide) in Overweight and Obese Adult Volunteers in China","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Peptide","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Peptide","graph2":"Sciwind"},{"orgOrder":0,"company":"HighTide Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HighTide Therapeutics Announces Early Completion of Enrollment in Phase 2 Clinical Study Evaluating HTD1801 in Type 2 Diabetes Mellitus","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"HighTide Therapeutics"},{"orgOrder":0,"company":"HighTide Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HighTide Therapeutics Announces Presentations at The Liver Meeting\u00ae 2022","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"HighTide Therapeutics"},{"orgOrder":0,"company":"HighTide Therapeutics","sponsor":"TCM Healthcare","pharmaFlowCategory":"D","amount":"$107.0 million","upfrontCash":"Undisclosed","newsHeadline":"HighTide Therapeutics Raises $107 Million in Series C\/C+ Financing to Advance Innovative Pipeline and Business Collaborations","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"HighTide Therapeutics"}]
Find Clinical Drug Development Pipelines & Deals | PipelineProspector
HighTide's lead candidate HTD1801 (berberine ursodeoxycholate), is a novel multifunctional molecule, being developed for the treatment of patients suffering from complex metabolic and digestive diseases.
The data showing positive changes in gut microbiota are encouraging and provide another mechanism of action underlying the beneficial effects of HTD1801 (Berberine Ursodeoxycholate) in liver and metabolic diseases.
The unique design of HTD1801 (berberine ursodeoxycholate) results in its pleiotropic therapeutic effects. Previous Phase 2 study in adults with comorbid nonalcoholic steatohepatitis (NASH) and T2DM completed in the United States demonstrated overall clinical benefits.
After 14 weeks of treatment, participants receiving 1.8 mg and 2.4 mg XW003 (ecnoglutide) achieved statistically significant mean body weight loss of 8.32 kg (9.6%) and 7.27 kg (9.0%), respectively, compared to 0.62 kg (0.9%) for those receiving placebo (P<0.0001).
At week 20, participants receiving 0.4 mg, 0.8 mg, and 1.2 mg XW003 (ecnoglutide) had statistically significant HbA1c reductions from baseline of 1.8%, 1.9% and 2.4%, respectively, compared to 0.5% in participants receiving placebo (P < 0.0001).
Least squares mean changes from baseline to week 12 in HbA1c levels were −1.46%, −2.23% and −1.66% for patients receiving IBI362 (mazdutide) in cohort 1,2 and 3, respectively (−1.98% for dulaglutide).
HTD1801 is a first-in-class new molecular entity with pleiotropic effects, designed to target both the metabolic pathways critical to the development of T2DM and pathogenic factors underlying liver dysfunction and the progression of NAFLD.
Company announced the completion of patient enrollment in Phase 2 trial of XW003 a novel, long-lasting GLP-1 peptide analog optimized for improved biological activity, cost-effective manufacturing, and once weekly dosing.
IBI362, novel dual GLP-1 receptor and glucagon receptor agonist, has shown a favorable safety profile in Chinese patients with type 2 diabetes, together with multiple benefits of glycemic control, weight loss and metabolic profiles.
IBI362 is a randomized, multicenter phase 2 clinical trial to evaluate the efficacy and safety of IBI362 as compared with placebo and dulaglutide in patients with type 2 diabetes in China.