PG-102 / ProGen, SL Metagen - LARVOL DELTA

ProGen lands $15.5 mil. from Yuhan, new backer JW to advance dual-target obesity drug (Korea Biomedical Review) - "ProGen has raised 22 billion won ($15.5 million) from a group of backers including Korea’s Yuhan Corp. and JW Pharmaceutical to speed up trials for its dual-agonist obesity drug and transition from Korea’s Konex to Kosdaq market later this year....The funding—comprised of convertible preferred shares and bonds—will support clinical trials and operations tied to PG-102, a dual GLP-1/GLP-2 receptor agonist currently in a phase 2 trial in Korea."

Financing • Obesity • Type 2 Diabetes Mellitus

Rani Therapeutics Announces Preclinical Data Demonstrating Bioequivalence of RT-114, a GLP-1/GLP-2 Dual Agonist (PG-102) Delivered Orally via the RaniPill Capsule, to Subcutaneously Administered PG-102 (GlobeNewswire) - "Rani Therapeutics Holdings...today announced pharmacokinetic and pharmacodynamic data from a preclinical study evaluating RT-114, a GLP-1/GLP-2 dual agonist (PG-102). PG-102 delivered orally via the RaniPill capsule demonstrated comparable bioavailability and weight loss to subcutaneously (SC) injected PG-102 ('SC PG-102'). PG-102 is ProGen Co., Ltd’s ('ProGen') Fc-fusion protein conjugated GLP-1/GLP-2 dual agonist."

Preclinical • Obesity

Progen, 'GLP-1/GLP-2' Obesity Phase 1 "Preliminary Efficacy Confirmed" [Google translation] (Biospectator) - P1 | N=34 | "ProGen announced on the 25th that it confirmed the weight loss effect and tolerability in the phase 1 repeated dose clinical trial (Part C) of the next-generation obesity and diabetes treatment candidate 'PG-102'...Efficacy evaluation results showed that patients in Cohort 2 showed an average weight loss of 4.8% and a maximum weight loss of 8.7% at week 5...Safety assessment results showed that nausea occurred in less than 30% of patients, diarrhea in less than 20% of patients, and no cases of vomiting were reported...ProGen plans to present the safety, tolerability, and weight loss results from the Phase 1 clinical trial of PG-102 through an oral presentation at the Asian Association for the Study of Diabetes (AASD 2025)....ProGen plans to submit an Investigational New Drug (IND) phase 1 clinical trial plan for 'RPG-102 (RT-114),' an oral obesity treatment drug being jointly developed with Rani Therapeutics in the United States, in the first half of this year."

IND • New P1 trial • P1 data • Diabetes • Obesity

Phase II Study of PG-102(MG12) Compared with Placebo in Obesity and Type 2 Diabetes (clinicaltrials.gov) - P2 | N=144 | Recruiting | Sponsor: ProGen. Co., Ltd. | Enrolling by invitation ➔ Recruiting

Enrollment status • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Phase II Study of PG-102(MG12) Compared with Placebo in Obesity and Type 2 Diabetes (clinicaltrials.gov) - P2 | N=144 | Enrolling by invitation | Sponsor: ProGen. Co., Ltd. | Not yet recruiting ➔ Enrolling by invitation

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

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of PG-102 (MG12) in Healthy Adult and Obesity Participants. (clinicaltrials.gov) - P1 | N=118 | Recruiting | Sponsor: ProGen. Co., Ltd. | N=90 ➔ 118 | Initiation date: Oct 2023 ➔ Mar 2024

Enrollment change • Trial initiation date • Genetic Disorders • Obesity

Phase II Study of PG-102(MG12) Compared With Placebo in Obesity and Type 2 Diabetes (clinicaltrials.gov) - P2 | N=144 | Not yet recruiting | Sponsor: ProGen. Co., Ltd.

New P2 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study to Assess Safety, Pharmacokinetics and Pharmacodynamics of PG-102(MG12) in Healthy Volunteers (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: ProGen. Co., Ltd. | Trial completion date: Jun 2024 ➔ Oct 2026 | Trial primary completion date: Jun 2024 ➔ Feb 2026

Trial completion date • Trial primary completion date • Obesity

Progen, next-generation obesity and diabetes treatment 'PG-102' domestic phase 2 clinical trial plan approved [Google translation] (E-Today) - "Prozen announced on the 8th that it had received approval from the Ministry of Food and Drug Safety for the domestic phase 2 clinical trial plan (IND) for 'PG-102', which is being developed as a next-generation obesity and diabetes treatment drug. The phase 2 clinical trial will be conducted as a placebo-controlled and active-controlled trial to evaluate the safety and efficacy of PG-102 for patients with type 2 diabetes and obesity."

New P2 trial • Metabolic Disorders • Obesity

Progen, 'PG-102' nonclinical and early clinical results presented at the American Diabetes Association [Google translation] (The Bio) - "Progene announced on the 24th that it had presented the non-clinical and early clinical results of its next-generation dual-target obesity and diabetes treatment candidate, 'PG-102 (development code name),' in a poster session at the 84th American Diabetes Association (ADA) held at the Orlando Convention Center in the United States. In particular, the company explained that in a non-clinical animal model, it showed a superior blood sugar control effect than 'letatrutide'....According to Progene, PG-102...and showed superior glycemic control effects compared to competing substances in a mouse model of type 2 diabetes accompanied by obesity. While semaglutide, terzepatide, and retatrutide showed a maximum reduction of 1.8%, 2.5%, and 2.5% in glycated hemoglobin, respectively, PG-102 reached the normal range with a reduction of 5.2% without any hypoglycemic issues in a short period of time."

Preclinical • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Progen, 'PG-102' nonclinical and early clinical results presented at the American Diabetes Association [Google translation] (The Bio) - P1 | N=90 | NCT06309667 | Sponsor: ProGen. Co., Ltd. | "Progene also announced the results of a phase 1a clinical trial of a single ascending dose (SAD) of PG-102. The results showed that PG-102 exhibited excellent safety and tolerability, and showed differentiated safety compared to the frequency of gastrointestinal side effects of competing drugs in the same clinical stage. The possibility of developing a biweekly and monthly dosing formulation of PG-102 was also confirmed through pharmacokinetic and pharmacodynamic simulation of the phase 1a clinical trial and nonclinical study results."

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

ProGen's obesity and diabetes treatment chosen for trial project by KDDF (Korea Biomedical Review) - "ProGen announced on Wednesday that its dual-target obesity and diabetes treatment, PG-102, has been selected as a support project for a phase 1 trial of the Korea Drug Development Fund (KDDF), led by Director Park Yeong-min. The project's goal is to accelerate the clinical development and early release of PG-102, positioning it as a new treatment for obesity and diabetes on a global scale....ProGen said, in preclinical animal models, PG-102 showed more than twice the fat-selective reduction efficacy compared to semaglutide and tirzepatide. It also demonstrated improved blood glucose control in hyperglycemia with a lower risk of hypoglycemia, and exhibited anti-inflammatory effects, the company said. These outcomes are attributed to the combined mechanisms of GLP-2, which could potentially address various side effects associated with existing GLP-1-based treatments."

Financing • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study to Assess Safety, Pharmacokinetics and Pharmacodynamics of PG-102(MG12) in Healthy Volunteers (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: ProGen. Co., Ltd.

New P1 trial • Obesity

Fat specific weight loss in diet-induced obesity mouse model when treated with bispecific GLP-1R/GLP-2R agonist vs dual GLP-1R/GIPR agonist (EASD 2023) - "In our study, while there was similar BW reduction in both groups, the MG12 treated group had profound fat specific mass reduction compared to the dual GLP-1R/GIPR agonist group."

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