DF-006 / Drug Farm - LARVOL DELTA

Drug Farm and Xiamen Amoytop Biotech Co., Ltd. Enter into Option Agreement for First-In-Class Innate Immunity Agonist, DF-006 to Treat Hepatitis B and Hepatocellular Cancer (Yahoo Finance) - "Drug Farm...today announced that it has entered into an option agreement with Amoytop. The two parties will engage in clinical collaboration with Drug Farm’s first-in-class ALPK1 agonist, DF-006 in the field of ​hepatitis B and hepatocellular cancer in the ​Greater China region (Mainland China, Taiwan region, Hong Kong, and Macau)."

Licensing / partnership • Hepatocellular Cancer

A PHASE 1, DOUBLE-BLINDED, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER GLOBAL STUDY EVALUATING THE SAFETY, TOLERABILITY, ANTIVIRAL ACTIVITY AND PHARMACODYNAMIC RESPONSES OF DF-006 IN CHRONIC HEPATITIS B, VIROLOGICALLY-SUPPRESSED SUBJECTS (AASLD 2024) - "DF-006 is safe and well tolerated in VS HBeAg-negative subjects after 4 weeks of PO QW dosing up to 1 mcg. The PD data suggests that DF-006-induced on-treatment immune activation may have led to HBsAg reduction."

Clinical • P1 data • PK/PD data • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Oncology • CCL2 • CXCL8 • IFNB1 • IFNG • IL17A • IL18 • IL6 • TNFA

A Phase 1, Placebo-controlled, First-in-human Study of Orally Administered DF-006 to Evaluate the Safety, Tolerability, and Pharmacokinetics After Multiple Doses in Chronic Hepatitis B subjects (ANZCTR) - P1 | N=120 | Completed | Sponsor: Zhejiang Yao Yuan Biotechnology Ltd. (Drug Farm) | Not yet recruiting ➔ Completed | Initiation date: Jul 2023

Trial completion • Trial initiation date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A phase 1, double-blinded, randomized, placebo-controlled, multicenter global study evaluating the safety, tolerability, and antiviral activity of DF-006 in chronic hepatitis B, virologically-suppressed patients (EASL-ILC 2024) - "DF-006 is safe and well tolerated in VS HBeAg-negative CHB subjects after 4 weeks of PO QW dosing up to 1 mcg. Most VS CHB subjects with baseline HBsAg > 2000 IU/mL achieved off-treatment HBsAg reductions . These data support further evaluation of DF-006 in a Phase 2 study."

Clinical • Late-breaking abstract • P1 data • Fatigue • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Drug Farm Announces anti-HBV immunomodulator, DF-006 is Accepted as a Late-Breaking Presentation at the 2024 European Association for the Study of the Liver Conference (Businesswire) - "Drug Farm...today announced that the chronic hepatitis B patient data from their Phase 1b trial (ACTRN12621000592842) was accepted as a late breaking poster presentation at the 2024 European Association for the Study of the Liver (EASL) conference that will be held in Milan, Italy between 05 June 2024 to 08 June 2024."

Late-breaking abstract • P1 data • Hepatitis B • Infectious Disease

A Phase 1, Placebo-controlled, First-in-human Study of Orally Administered DF-006 to Evaluate the Safety, Tolerability, and Pharmacokinetics After a Single Dose and Multiple Doses in Healthy Subjects (ANZCTR) - P1 | N=34 | Completed | Sponsor: Zhejiang Yao Yuan Biotechnology Ltd. (Drug Farm) | Not yet recruiting ➔ Completed

Trial completion • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Phase 1, Placebo-controlled, First-in-human Study of Orally Administered DF-006 to Evaluate the Safety, Tolerability, and Pharmacokinetics After Multiple Doses in Chronic Hepatitis B subjects (ANZCTR) - P1 | N=120 | Not yet recruiting | Sponsor: Zhejiang Yao Yuan Biotechnology Ltd. (Drug Farm)

New P1 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation