GFB-024
/ Goldfinch Bio, Takeda
- LARVOL DELTA
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July 16, 2022
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
May 11, 2022
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
March 28, 2022
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
December 01, 2021
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
October 17, 2021
[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
May 10, 2021
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
June 30, 2020
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
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