GFB-024 / Goldfinch Bio, Takeda - LARVOL DELTA

Phase 1, Randomized, Controlled Trial of GFB-024, a Once-Monthly CB1 Inverse Agonist, in Healthy Overweight and Obese Participants and in Participants with Type 2 Diabetes Mellitus (ENDO 2022) - "In summary, GFB-024 was safe and well tolerated following single doses of up to 300 mg. PK analysis demonstrated potentially efficacious exposure, a prolonged absorption phase, and elimination half-life compatible with once-monthly dosing."

Clinical • P1 data • Diabetes • Diabetic Nephropathy • Fibrosis • Genetic Disorders • Immunology • Inflammation • Metabolic Disorders • Nephrology • Obesity • Renal Disease • Type 2 Diabetes Mellitus

Phase 1, Randomized, Controlled Trial of GFB-024, a Once-Monthly CB1 Inverse Agonist, in Healthy Overweight and Obese Participants and in Participants with Type 2 Diabetes Mellitus (ADA 2022) - "Elimination half-life was approximately 12-13 days, with exposures remaining in the estimated efficacious range at 28 days for all but the lowest dose tested.In summary, GFB-024 was safe and well tolerated following single doses of up to 300 mg. PK analysis demonstrated potentially efficacious exposure, a prolonged absorption phase, and elimination half-life compatible with once-monthly dosing."

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

First-In-Human Study of GFB-024 in Healthy Overweight and Obese Participants, and Participants With Type 2 Diabetes (clinicaltrials.gov) - P1 | N=39 | Completed | Sponsor: Goldfinch Bio, Inc. | Recruiting ➔ Completed | N=56 ➔ 39

Enrollment change • Trial completion • Diabetes • Diabetic Nephropathy • Endocrine Disorders • Metabolic Disorders • Nephrology • Obesity • Renal Disease • Type 2 Diabetes Mellitus

First-In-Human Study of GFB-024 in Healthy Overweight and Obese Participants, and Participants With Type 2 Diabetes (clinicaltrials.gov) - P1; N=56; Recruiting; Sponsor: Goldfinch Bio, Inc.; Trial completion date: Nov 2021 ➔ Apr 2022; Trial primary completion date: Nov 2021 ➔ Apr 2022

Clinical • Trial completion date • Trial primary completion date • Diabetes • Diabetic Nephropathy • Endocrine Disorders • Metabolic Disorders • Nephrology • Obesity • Renal Disease • Type 2 Diabetes Mellitus

[VIRTUAL] Phase 1, Randomized, Controlled Trial of GFB-024 in Healthy Overweight and Obese Participants and in Participants With Type 2 Diabetes Mellitus (KIDNEY WEEK 2021) - P1 | "The duration of the study is up to 18 weeks. Results from this trial will provide the foundational evidence to support the clinical development of GFB-024 in patients with DN driven by CB1 activation."

Clinical • P1 data • Diabetes • Diabetic Nephropathy • Fibrosis • Genetic Disorders • Glomerulonephritis • Immunology • Inflammation • Metabolic Disorders • Nephrology • Obesity • Renal Disease • Type 2 Diabetes Mellitus

First-In-Human Study of GFB-024 in Healthy Overweight and Obese Participants, and Participants With Type 2 Diabetes (clinicaltrials.gov) - P1; N=56; Recruiting; Sponsor: Goldfinch Bio, Inc.

Clinical • New P1 trial • Diabetes • Diabetic Nephropathy • Endocrine Disorders • Metabolic Disorders • Nephrology • Obesity • Renal Disease • Type 2 Diabetes Mellitus

After its $2B Gilead pact, Goldfinch Bio nabs a cool $100M series B (FierceBiotech) - "Today, it got off an oversubscribed series B financing worth $100 million...Goldfinch is now pushing two programs through development: GFB-887, a first-in-class selective inhibitor of transient receptor potential canonical channel 5 (TRPC5), and GFB-024, a peripherally restricted cannabinoid receptor 1 (CB1) inverse agonist. A phase 2 of GFB-887 in patients with FSGS and diabetic nephropathy (DN)...are slated for mid-20201, with an IND for GFB-024, licensed from Takeda, to treat CB1-mediated DN on the cards for 2021. The $100 million will go toward these efforts."

Financing • IND • New P2 trial • Diabetic Nephropathy • Focal Segmental Glomerulosclerosis • Neuralgia • Pain • Peripheral Neuropathic Pain • Renal Disease