ecnoglutide SC (XW003) / Sciwind Biosci, Korea Kolmar - LARVOL DELTA

…Hanmi Pharmaceuticals to conduct phase 3 new drug trial [Google translation] (Nate) - "In addition to Hanmi Pharmaceutical, HK inno.N...submitted a phase 3 clinical trial plan for its obesity drug candidate 'IN-B00009' to the Ministry of Food and Drug Safety at the end of last year. It plans to start clinical trials next month and complete them in early 2028....Dong-A ST (170900), is conducting phase 1 clinical trials for its obesity drug 'DA-1726'. It plans to release the first clinical results in the third quarter of this year."

New P3 trial • P1 data • Trial completion date • Obesity

Efficacy and safety of GLP-1 analog ecnoglutide in adults with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 2 trial. (PubMed, Nat Commun) - "Ecnoglutide (XW003) is a novel, long-acting GLP-1 analog...Ecnoglutide was generally safe and well tolerated. China Drug Trials Registry CTR20211014."

Clinical • Journal • P2 data • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A phase 3 evaluation of cAMP signalling biased GLP-1 analogue ecnoglutide in adults with type 2 diabetes (EASD 2024) - P3 | "Background and aims: Ecnoglutide (XW003) is a cAMP signaling biased GLP-1 analog being developed for the treatment of type 2 diabetes mellitus (T2DM) and obesity... Ecnoglutide resulted in robust HbA1c declines of up to 2.43% from baseline after 24 weeks of treatment in adults with T2DM, with up to 35.2% of participants reaching normoglycemia (HbA1c <5.7%) and 43.7% with weight reductions ≥5%."

Clinical • P3 data • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Phase 3 Study to Evaluate the Efficacy of XW003 in Adults With Overweight or Obesity (clinicaltrials.gov) - P3 | N=664 | Active, not recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. | Trial primary completion date: Jan 2025 ➔ Jun 2024

Trial primary completion date • Genetic Disorders • Obesity

Biased GLP-1 Analog Ecnoglutide (XW003) Has Improved Efficacy Relative to Unbiased Peptides (ADA 2024) - "This compared to -1.14% reported for liraglutide (1.8 mg at 52 weeks), -1.55% to -1.86% for semaglutide (1.0 mg at 30-40 weeks), and -1.46% for dulaglutide (1.5 mg at 26 weeks). Bias for the cAMP pathway results in sustained signaling that correlates with increased clinical efficacy compared to unbiased GLP-1 analogs."

Clinical • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Sciwind Biosciences to Highlight Positive Results for Injectable Ecnoglutide (Phase 3), Oral Ecnoglutide (Phase 1), and Novel Amylin Analogs at the American Diabetes Association (ADA) 84th Annual Conference (PRNewswire) - P3 | N=664 | NCT05813795 | P1 | N=90 | NCT05184322 | Sponsor: Sciwind Biosciences APAC CO Pty. Ltd. | "A Phase 1 study of oral ecnoglutide (1871-LB) showed it to be safe and well tolerated and result in pronounced weight loss (up to -6.76% after 6 weeks of dosing). Improved oral bioavailability enables a 15 to 30 mg daily dose of oral ecnoglutide to match or exceed the plasma exposure of weekly subcutaneous GLP-1 analogs for weight loss. In a Phase 3 study in participants with type 2 diabetes (T2DM) (742-P, 793-P), weekly subcutaneous ecnoglutide resulted in robust HbA1c declines of up to -2.43% from baseline after 24 weeks of treatment, with up to 35.2% of participants reaching normoglycemia (HbA1c <5.7%) and 43.7% with weight reductions ≥5%....Sciwind Biosciences Co., Ltd... today announced that the company will present...at the American Diabetes Association (ADA) 84th Annual Conference."

P1 data • P3 data • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Phase 3 Evaluation of cAMP Signaling Biased GLP-1 Analog Ecnoglutide (XW003) in Adults with Type 2 Diabetes (ADA 2024) - "Ecnoglutide resulted in robust HbA1c declines of up to 2.43% from baseline after 24 weeks of treatment in adults with T2DM, with up to 35.2% of participants reaching normoglycemia (HbA1c <5.7%) and 43.7% with weight reductions ≥5%."

Clinical • P3 data • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Synergistic Body Weight Reduction of GLP-1 Analog Ecnoglutide and Amylin Analogs in Preclinical Animal Models (ADA 2024) - "The objective of this study was to assess the efficacy of GLP-1 analog ecnoglutide (XW003) combined with novel amylin analogs in rodent models. Amylin peptides were designed and tested in CHO-K1 CRE reporter cells expressing the amylin receptor complex (human calcitonin receptor and Ramp3) (AMY3) or calcitonin receptor alone (CTR). Novel amylin analogs (Cmpd A and Cmpd B) showed similar in vitro activities to cagrilintide. In preclinical animal models, combination of amylin analogs with GLP-1 analog ecnoglutide demonstrated a synergistic effect on body weight reduction."

Preclinical • Metabolic Disorders • Obesity

HK inno.N licenses in GLP-1 analog from Chinese biotech (Korea Biomedical Review) - "HK inno.N...announced its strategic entry into the rapidly growing global obesity treatment market through a partnership with Sciwind Biosciences, a Chinese biotech firm....This collaboration is centered around the development and commercialization of Sciwind Biosciences' glucagon-like peptide-1 (GLP-1) analog, ecnoglutide (XW003), in Korea....Under the accord, HK inno.N will make an upfront payment to Sciwind, along with milestone payments and royalties based on sales post-launch. However, the company did not disclose the size of the contract, citing contractual reasons."

Licensing / partnership • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Sciwind Biosciences Announces Positive Topline Results from Phase 3 Clinical Trial of Ecnoglutide (XW003), a Long-acting cAMP Signaling Biased GLP-1 Analog, in Adult Patients with Type 2 Diabetes in China (PRNewswire) - P3 | N=211 | NCT05680155 | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. | "Sciwind Biosciences...announced positive topline results from a Phase 3 clinical trial of ecnoglutide (XW003) in Chinese adults with type 2 diabetes mellitus (T2DM)....After 24 weeks of treatment, participants receiving ecnoglutide achieved statistically significant reductions in HbA1c. The majority of the participants receiving ecnoglutide achieved HbA1c of less than 7% (the American Diabetes Association's recommended target for people with diabetes) and a significant proportion achieved HbA1c of less than 5.7%. There were also significant body weight decreases for participants receiving ecnoglutide....Overall safety and tolerability of ecnoglutide in this study was consistent with the established profile of GLP-1 receptor agonists."

P3 data: top line • Type 2 Diabetes Mellitus

Effects of XW003 Versus Liraglutide on Body Weight of Adult Participants With Obesity (clinicaltrials.gov) - P2 | N=206 | Completed | Sponsor: Sciwind Biosciences APAC CO Pty. Ltd. | Recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

A Phase 3 Study to Evaluate the Efficacy of XW003 in Adults With Overweight or Obesity (clinicaltrials.gov) - P3 | N=664 | Active, not recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM (clinicaltrials.gov) - P3 | N=623 | Active, not recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients (clinicaltrials.gov) - P3 | N=211 | Active, not recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

An Open-Label, Active-Controlled Phase 2 Evaluation of Novel GLP-1 Analog Ecnoglutide in Adults with Obesity (ADA 2023) - "Ecnoglutide (XW003) is a novel, long-acting GLP-1 analog being developed for the treatment of type 2 diabetes mellitus (T2DM) and obesity...Participants were randomized to receive target doses of ecnoglutide at 1.2, 1.8, or 2.4 mg as once weekly SC injections or liraglutide (Saxenda®) at 3.0 mg as once daily injections for 26 weeks...Two SAEs related to the study drug were reported. Both were cases of acute cholecystitis, one in a participant receiving 1.2 mg ecnoglutide and one in the liraglutide group."

Clinical • Late-breaking abstract • P2 data • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Phase 1c Evaluation of a Novel GLP-1 Analog Ecnoglutide (XW003) for Weight Loss in Adults with Overweight and Obesity (ADA 2023) - "The most frequent AEs were gastrointestinal, including diarrhea and vomiting. No drug-related SAE or drug-related AEs ≥Grade 3 were reported."

Clinical • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Phase 2 Evaluation of a Novel GLP-1 Analog Ecnoglutide (XW003) for Glycemic Control in Adults with Type 2 Diabetes (ADA 2023) - "The proportion of participants reporting any AE ranged from 72.2 to 78.4% for ecnoglutide and 58.3 % for placebo. The most frequently reported AEs were gastrointestinal, including diarrhea and nausea."

Clinical • P2 data • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Discovery of ecnoglutide - a novel, long-acting, cAMP-biased glucagon-like peptide-1 (GLP-1) analog. (PubMed, Mol Metab) - P1 | "Ecnoglutide showed a favorable potency, pharmacokinetic, and tolerability profile, as well as a simplified manufacturing process. These results support the continued development of ecnoglutide for the treatment of type 2 diabetes and obesity."

Journal • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Pain • Type 2 Diabetes Mellitus

A Phase 3 Study to Evaluate the Efficacy of XW003 in Adults With Overweight or Obesity (clinicaltrials.gov) - P3 | N=660 | Not yet recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.

New P3 trial • Genetic Disorders • Obesity

A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients (clinicaltrials.gov) - P3 | N=210 | Recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients (clinicaltrials.gov) - P3 | N=210 | Not yet recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Synergistic activity of GLP-1 peptide analog XW003 and the long-lasting GIP receptor agonist XW017 in a diet induced obese mouse model (EASL-ILC 2022) - "In conclusion, combinatory treatment of GLP-1 and GIP receptor agonists showed a synergistic effect on promoting weight loss in a mouse model of obesity."

Preclinical • Addiction (Opioid and Alcohol) • Diabetes • Genetic Disorders • Hepatology • Non-alcoholic Steatohepatitis • Obesity • Type 2 Diabetes Mellitus

Effects of XW003 Versus Liraglutide on Body Weight of Adult Participants With Obesity (clinicaltrials.gov) - P2; N=200; Recruiting; Sponsor: Sciwind Biosciences APAC CO Pty. Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Genetic Disorders • Obesity