DD01 / D&D Pharmatech, Shenzhen Salubris - LARVOL DELTA

D&D Pharmatech Announces Positive Phase 2 Results for DD01 in MASH with Robust Reductions in Liver Fat Accompanied by Improvements in Liver and Metabolic Health (Businesswire) - P2 | N=67 | DD01-DN-02 (NCT06410924) | Sponsor: Neuraly, Inc. | "Results of a planned 12-week assessment of safety and efficacy revealed DD01 was well tolerated, and the study’s primary endpoint was met. Following a 1:1 randomization of 40mg DD01 and placebo, 75.8% of subjects treated with DD01 achieved at least a 30% reduction in liver fat, 72.7% of subjects achieved greater than 50% reduction in liver fat, and 57.6% of subjects achieved greater than 70% liver fat reduction (in each case, with p < 0.0001). DD01 achieved a mean reduction of liver fat content of 62.3% vs 8.3% for placebo at 12 weeks of treatment, and 48.5% of DD01 subjects achieved normalization of liver fat fraction (defined as liver fat fraction of 5% or less by MRI-PDFF)."

P2 data • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

D&D Pharmatech Completes Database Lock for Phase 2 Clinical Trial of MASH Treatment in the US [Google translation] (HIT News) - P2 | N=67 | NCT06410924 | Sponsor: Neuraly, Inc. | "D&D Pharmatech announced on the 4th that it has completed the database lock for the analysis of the primary evaluation index in the US phase 2 clinical trial of 'DD01', a treatment for MASH (metabolic steatohepatitis)...This lock is based on data from all patients who completed the treatment by week....The clinical trial will be conducted at approximately 12 institutions in the United States, and will be designed as a randomized, double-blind, placebo-controlled study targeting 67 patients with a body mass index (BMI) of 25 or more and MASLD/MASH....D&D Pharmatech announced that based on the 12-week interim data secured by the end of March, 16 out of 50 subjects, who were not divided into the placebo and treatment groups, showed a 70% or greater reduction in liver fat."

P2 data • Trial status • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

D&D Pharmtech scores US patent for MASH drug candidate DD01 (Korea Biomedical Review) - "D&D Pharmatech, a Korean developer of GLP-1-based therapeutics, announced Tuesday that it has secured a U.S. patent for DD01, its investigational treatment for metabolic-associated steatohepatitis (MASH)....The U.S. patent is the second international registration for DD01, following the initial filing in Korea in 2019 and recent approval in Australia....The ongoing phase 2 study is designed as a 48-week trial, with dosing continuing after confirmation of the primary endpoint...including biopsy-confirmed resolution of MASH and improvement in liver fibrosis after 48 weeks. Final results are anticipated in the first half of 2026."

P2 data • Patent • Metabolic Dysfunction-Associated Steatohepatitis

D&D Pharmatech completes US phase 2 dosing of MASH drug, eyes June data release (Korea Biomedical Review) - "D&D Pharmatech, a GLP-1 drug developer, said Friday it has completed week 12 dosing of all patients in its U.S. phase 2 clinical trial of DD01, a drug for metabolic-associated steatohepatitis (MASH)....The company is analyzing key data, including the primary endpoint, MRI-PDFF, and will release the results by June....The primary endpoint will be assessed using MRI-PDFF at week 12 of the 48-week treatment period to determine the proportion of patients with at least a 30 percent reduction in liver fat, and at week 48, tissue biopsies will be taken to confirm resolution of MASH and improvement in fibrosis, providing key data for FDA approval....Results from the primary endpoint are expected in mid-June, subject to completion of week 12 dosing for all patients."

P2 data • Trial status • Metabolic Dysfunction-Associated Steatohepatitis

D&D Pharmatech, MASH Treatment 'DD01', Australian Patent Registration Decision [Google translation] (BioTimes) - "D&D Pharmatech (347850), a company specializing in the development of GLP-1 series new drugs, announced on the 2nd that it has decided to register an Australian patent for 'DD01', a MASH (metabolic steatohepatitis) treatment drug that the company is developing."

Patent • Metabolic Dysfunction-Associated Steatohepatitis

DD01-DN-02: A Study to Evaluate DD01 in Overweight/Obese Subjects with MASLD/MASH (clinicaltrials.gov) - P2 | N=68 | Active, not recruiting | Sponsor: Neuraly, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

D&D Pharmatech Announces Completion of Patient Enrollment for a 48-Week Phase 2 Trial Evaluating the Effectiveness of DD01, a Long-Acting, Dual GLP-1/Glucagon Receptor Agonist, in the Treatment of MASH (Businesswire) - "D&D Pharmatech, Inc...today, announced that patient enrollment has been completed for DD01-DN-2, an ongoing Phase 2 trial designed to evaluate the efficacy and safety of DD01 in overweight/obese subjects with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH)...The top-line 12-week efficacy and safety results will be announced in late Q2 2025."

Enrollment closed • P2 data • Metabolic Dysfunction-Associated Steatohepatitis

D&D Pharmatech Announces Initiation of Dosing in a Phase 2 Trial Designed to Evaluate the Efficacy and Safety of DD01, a Long-Acting, Dual GLP-1/Glucagon Receptor Agonist in Overweight/Obese Subjects with MASLD/MASH (Businesswire) - "D&D Pharmatech, Inc...announced that dosing has commenced in a Phase 2 trial designed to evaluate the efficacy and safety of DD01 in overweight/obese subjects with metabolic dysfunction-associated steatotic liver disease (MASLD)/metabolic dysfunction-associated steatohepatitis (MASH)."

Trial status • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

DND Pharmatech's MASH Treatment Candidate 'DD01' Passes Phase 2 IND Review from FDA [Google translation] (eDaily) - "D&D Pharmatech...announced that the phase 2 clinical trial protocol (IND) for its self-developed new drug candidate for the treatment of metabolic steatohepatitis (MASH), 'DD01', has passed the review of the U.S. Food and Drug Administration(FDA).The day was revealed. According to DND Pharmatech, this phase 2 clinical trial will be conducted simultaneously at about 10 clinical trial sites in the United States targeting approximately 68 overweight or obese patients with MASH. The company plans to conduct a 48-week randomization, double-blind, placebo controlled, parallel comparison method to evaluate the efficacy and safety of DD01.The expected completion date of the clinical trial is June 2026."

IND • New P2 trial • Trial completion date • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity

A Study to Evaluate DD01 in Overweight/Obese Subjects With MASLD/MASH (clinicaltrials.gov) - P2 | N=68 | Recruiting | Sponsor: Neuraly, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

A Study to Evaluate DD01 in Overweight/Obese Subjects With MASLD/MASH (clinicaltrials.gov) - P2 | N=68 | Not yet recruiting | Sponsor: Neuraly, Inc.

New P2 trial • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

D&D Pharmatech submits IND to US FDA for phase 2 clinical trial of MASH treatment ‘DD01’ [Google translation] (Hankyung) - "D&D Pharmatech announced on the 9th that it has submitted an clinical trial plan (IND) to the U.S. Food and Drug Administration (FDA) for Phase 2 clinical trials of its self-developed injectable metabolic disorder-related steatohepatitis (MASH) treatment 'DD01'....This phase 2 clinical trial will be conducted on obese and overweight patients with metabolic abnormality-related steatohepatitis (MASLD·MASH). To evaluate the efficacy and safety of DD01, multiple clinical trial centers plan to conduct a 48-week randomized, double-blind, placebo-controlled, parallel comparison method. In this phase 2 clinical trial, the company plans to compare and analyze the effectiveness of reducing fatty liver and liver fibrosis through magnetic resonance imaging-proton density fat ratio (MRI-PDFF) of the treatment group compared to placebo and liver tissue biopsy measurement results, which is the FDA approval standard for MASH treatment."

IND • New P2 trial • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

A Phase 1 Study of DD01 in Overweight/Obese Subjects With T2DM and NAFLD (clinicaltrials.gov) - P1 | N=255 | Completed | Sponsor: Neuraly, Inc. | Recruiting ➔ Completed | N=120 ➔ 255

Enrollment change • Trial completion • Diabetes • Genetic Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Type 2 Diabetes Mellitus

D&D Pharmatech Granted Fast Track Designation from US FDA for DD01 for the Treatment of NASH/MASH (Businesswire) - "D&D Pharmatech, Inc...announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of DD01 for the treatment of adults with non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH). FDA Fast Track designation is intended to bring promising drugs to patients sooner by facilitating the development and expediting the review of drugs that fulfill unmet needs in serious diseases....The FDA based its decision on data from Phase 1, a randomized, double-blind, placebo-controlled study assessing the safety and efficacy of DD01 in overweight/obese subjects with type 2 diabetes (T2D) and metabolic dysfunction-associated fatty liver disease (MAFLD)."

Fast track designation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

Dramatic reductions in hepatic steatosis accompanied by improved HbA1c following a 4-week treatment of obese/diabetic/NAFLD patients with DD01, a novel long-acting GLP-1/glucagon receptor agonist (EASL-ILC 2023) - "DD01 acts through the GLP-1 receptor and glucagon receptor pathways to improve glucose control and rapidly reduce hepatic steatosis. Weight loss is observed at higher doses and it appears that rapid resolution of hepatic steatosis can be achieved independent of weight loss. The combined effects of DD01 may be useful in the treatment of NASH and NAFLD both with and without co-occurring diabetes."

Clinical • Late-breaking abstract • Diabetes • Genetic Disorders • Hepatology • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • Obesity • Type 2 Diabetes Mellitus

A Phase 1 Study of DD01 in Overweight/Obese Subjects With T2DM and NAFLD (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Neuraly, Inc. | N=88 ➔ 120 | Trial completion date: Jul 2022 ➔ Dec 2022 | Trial primary completion date: Jul 2022 ➔ Dec 2022

Enrollment change • Trial completion date • Trial primary completion date • Diabetes • Genetic Disorders • Hepatology • Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Obesity • Type 2 Diabetes Mellitus