MetaVia Inc. · NASDAQ:MTVA
MetaVia — EASD 57th Annual Meeting 2021
10 slides from MetaVia's conference presentation, Oct 1, 2021
Slide 1: DA-1241 a novel GPR119 Agonist: Multiple Ascending Dose Study Part 2 in T2DM
DA-1241 a novel GPR119 Agonist: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics - Part 2 of Multiple Ascending Dose Study in Type 2 Diabetes Patients Marcus Hompesch1, Bridgette Franey1, Michael Grimm1, Dae Young Lee2, Jiyoon Jeong2, Mi-Kyung Kim2, 1. ProSciento, Chula Vista, CA, USA; 2.
Slide 2: Disclosures
Disclosures • Bridgette Franey, Michael Grimm, and Marcus Hompesch are employees of ProSciento, Chula Vista, CA, USA • Mi-Kyung Kim, Dae Young Lee, and Jiyoon Jeong are employees of Dong-A ST, Seoul, Republic of Korea 2
Slide 3: Background
Background DA-1241 is a small, novel, chemically synthesized, potent molecule, and a selective agonist for GPR119. It has been reported that GPR119 stimulates glucose-dependent insulin secretion in the pancreatic beta cells which makes GPR119 a promising drug target for controlling glucose levels wi
Slide 4: Objectives and Endpoints
Objectives and Endpoints PRIMARYY OBJECTIVE: (a) The primary objective of this study was to assess safety and tolerability of multiple once daily oral doses of DA-1241 versus placebo and Sitagliptin in T2DM. SECONDARY OBJECTIVES: (b) To establish PK and characteristics in the target population. • Cm
Slide 5: Methods: Cohorts, Doses and Schedule of Events
Methods: Cohorts, Doses and Schedule of Events Abbreviations: BG: Blood Glucose; CGMS: Continuous Glucose Measurement System; MMTT: Mixed Meal Tolerance Test; PP: Post-Parndial; F/U: Follow-Up Visit 5
Slide 6: Results: Tolerability & PK
DA-1241 83 PBO Sitagliptin 25 mg 50 mg 100 mg N 19 13 19* 15 17 • 84 subjects were enrolled, and 83 subjects were dosed in Part Results: Tolerability & 2, 3 subjects were withdrawn due to TEAEs (1 active, 2 PK placebo), 72 subjects completed the study. • There were no relevant demographic imbalances
Slide 7: Results: Glucose Control
Results: Glucose Control Incremental Glucose AUE0-4h (Day 56-Day 1, h*mg/dL) • On day 56 MMTTs Glucose AUE0-4h had decreased in a dose-dependently compared to baseline. 100 +34.0 • MMTTs Glucose AUE0-4h correlated positively with CGMS 50 +18.5 AUE0-4h (r=0.6854, p<0.05) and HbA1c (r=0.6260, p<0.05).
Slide 8: Results: Glucose Control
Results: Glucose Control • Fasting plasma glucose trended towards improvement for all DA-1241 doses. • Multiple parameters from continuous glucose monitoring (CGM), trended towards improvement for all DA-1241 doses; especially time spent at BG < 180 mg/dL and glucose AUE0-24h. • After 8-week treatme
Slide 9: Results: Target-Related Biomarkers
Results: Target-Related Biomarkers Secretion of GIP, GLP-1 and PYY were increased at day 56 DA-1241 Sita in DA-1241-treated groups, Hormone AUE0-4h (pmol h/L) PBO 25 mg 50 mg 100 mg 100 mg consistent with the mechanism N 16 12 15 15 14 of action of DA-1241. tGLP-1 D-1 Mean 73.48 60.44 75.65 95.55 83
Slide 10: Conclusions
This phase 1b study in T2DM showed favorable safety, tolerability and PK profiles of DA-1241 administered daily over a period of 56 Conclusions days, compared to placebo or sitagliptin in the target population of subjects with T2DM on metformin monotherapy. Biomarkers and PD data support the hypothe