ALPK1 | Jotup

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

Retrieved on:

Thursday, May 2, 2024

Title: 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.

Key Points:

Title: 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.
DF-006 is a first-in-class, orally administered ALPK1 agonist immunomodulator that potently stimulates local, innate immunity in the liver1.
DF-006 has a novel mechanism of action that is capable of stimulating the body’s own immune system to help clear the infection.
“DF-006 has demonstrated potent antiviral responses in preclinical studies, including inhibition of cccDNA and recruitment of T-cells.

Drug Farm Receives Rare Pediatric Disease Designation from the U.S. FDA for DF-003 to Treat ROSAH Syndrome

Retrieved on:

Saturday, January 13, 2024

Drug Farm , a clinical-stage biopharmaceutical company announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) Designation for the company’s alpha-kinase 1 (ALPK1) inhibitor, DF-003, to treat patients with ROSAH (retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis and headache) Syndrome.

Key Points:

Drug Farm , a clinical-stage biopharmaceutical company announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) Designation for the company’s alpha-kinase 1 (ALPK1) inhibitor, DF-003, to treat patients with ROSAH (retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis and headache) Syndrome.
DF-003 is currently being evaluated in a Phase 1 trial ( NCT05997641 ) to assess safety and pharmacokinetics in normal healthy volunteers.
“Pediatric patients living with ROSAH Syndrome face a significant unmet need with limited options to treat vision loss,” said Jeysen Yogaratnam, Chief Medical Officer, Drug Farm.
“Obtaining Rare Pediatric Disease Designation recognizes the serious and debilitating complications of this rare disease and upholds our goal to provide DF-003 as the first targeted drug for potential treatment in patients afflicted with ROSAH Syndrome.”

Drug Farm Doses First Patient in Part 3 of Phase 1 Chronic Hepatitis B Trial

Retrieved on:

Tuesday, September 26, 2023

Drug Farm, a clinical-stage biopharmaceutical company, announced today that it has dosed the first chronic hepatitis B patient in Part 3 of its Phase 1 clinical trial (ANZCTR Trial ID: ACTRN12621000592842 ).

Key Points:

Drug Farm, a clinical-stage biopharmaceutical company, announced today that it has dosed the first chronic hepatitis B patient in Part 3 of its Phase 1 clinical trial (ANZCTR Trial ID: ACTRN12621000592842 ).
This trial is evaluating Drug Farm’s first-in-class ALPK1 agonist, DF-006, as a monotherapy and in combination with standard-of-care nucleos(t)side reverse transcriptase inhibitors in treatment-naïve and virologically suppressed patients with chronic hepatitis B infection.
Drug Farm is a private biotechnology company developing innovative treatments targeting innate immunity for hepatitis B, heart and kidney diseases, and ROSAH (retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis and headache) syndrome.
Using the IDInVivo platform, Drug Farm has identified novel innate immunity pathways and targets and is now rapidly advancing multiple first-in-class drug candidates into clinical development.

Drug Farm Doses First Patient in Phase 1 Trial for ALPK1 Inhibitor, DF-003

Retrieved on:

Tuesday, September 19, 2023

Drug Farm, a clinical-stage biopharmaceutical company, announced today that the first subject in the Phase 1 clinical trial ( NCT05997641 ) evaluating DF-003 in healthy volunteers has been dosed.

Key Points:

Drug Farm, a clinical-stage biopharmaceutical company, announced today that the first subject in the Phase 1 clinical trial ( NCT05997641 ) evaluating DF-003 in healthy volunteers has been dosed.
A gain-of-function mutation in ALPK1 also causes a rare genetic disease, ROSAH syndrome, that leads to blindness.
“The Phase 1 study will evaluate DF-003 in healthy volunteers with single and multiple ascending doses that will inform dose selection for the Phase 2 programs.
Using the IDInVivo platform, Drug Farm has identified novel innate immunity pathways and targets and is now rapidly advancing multiple first-in-class drug candidates into clinical development.

Drug Farm Announces IND Clearance by U.S. FDA Enabling Phase 1 Initiation for First-in-Class Oral ALPK1 Selective Kinase Inhibitor, DF-003

Retrieved on:

Thursday, June 29, 2023

Drug Farm announced today the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of DF-003, a first-in-class, oral, potent, highly selective ALPK1 inhibitor for clinical evaluation.

Key Points:

Drug Farm announced today the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of DF-003, a first-in-class, oral, potent, highly selective ALPK1 inhibitor for clinical evaluation.
ALPK1 has been linked to heart and kidney disease, and a mutated form of ALPK1 is the driver for the rare genetic disease, ROSAH, that leads to blindness.
DF-003 is a highly potent investigational inhibitor of ALPK1 and the ALPK1 T237M driver mutation that causes disease in ROSAH patients.
Using the IDInVivo platform, Drug Farm has identified novel innate immunity pathways and targets and is now rapidly advancing multiple first-in-class drug candidates into clinical development.

Drug Farm Raises $27M USD Financing for Advancement of First-In-Class Hepatitis B and Cardiovascular-Renal Drugs into Clinical Trials

Retrieved on:

Tuesday, May 16, 2023

With this financing round, Drug Farm will continue its clinical program on DF-006 and advance DF-003 into a first-in-human clinical trial.

Key Points:

With this financing round, Drug Farm will continue its clinical program on DF-006 and advance DF-003 into a first-in-human clinical trial.
DF-006 will now be evaluated in chronic hepatitis B patients in Part 3 of the multi-center trial.
DF-003 is a first-in-class orally active, potent, and highly selective ALPK1 kinase inhibitor that will enter clinical trials in 2023.
Drug Farm is a private biotechnology Company developing innovative treatments targeting innate immunity for hepatitis B, cancer, and autoimmune diseases.