Drug Farm Announces FDA Fast Track Designation for First-in-Class ALPK1 Inhibitor DF-003 for the Treatment of ROSAH Syndrome
Drug Farm, a clinical-stage biopharmaceutical company advancing two novel small molecule drugs for ROSAH syndrome and hepatitis B, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DF-003, its investigational, first-in-class ALPK1 inhibitor, for the treatment of ROSAH syndrome, a rare, autosomal dominant autoinflammatory disease with no approved therapies.
Drug Farm Announces Agreement with Cincinnati Children’s Hospital Medical Center to Explore ALPK1 Inhibitor, DF-003 as a Potential Treatment for Heart Disease and Blood Cancers Driven by Clonal Hematopoiesis
Drug Farm, a private biotechnology company utilizing genetics and artificial intelligence technologies to discover and develop innovative, immune-modulating therapies announced today that it has entered into a Material Transfer Agreement with Cincinnati Children’s Hospital Medical Center (CCHMC). Under the agreement, Drug Farm will provide DF-003 to the laboratory of Dr. Daniel Starczynowski, Katherine Stewart Waters Endowed Chair of Hematological Malignancies at CCHMC, to investigate the potential therapeutic benefits of ALPK1 inhibition in diseases associated with clonal hematopoiesis of indeterminate potential (CHIP). In conjunction with the collaboration, Dr. Starczynowski will join Drug Farm’s Scientific Advisory Board to provide expertise and strategic leadership.
Drug Farm Announces Publication in Nature Communications Describing the Discovery and Preclinical Characterization of First-in-Class ALPK1 inhibitor, DF-003
Drug Farm, a clinical stage, biopharmaceutical company advancing two novel small molecule drugs for ROSAH syndrome and hepatitis B today announced a peer-reviewed publication, “Discovery of a selective alpha-kinase 1 inhibitor for the rare genetic disease ROSAH syndrome”, in the high impact journal Nature Communications. The publication can be accessed at https://rdcu.be/eFaUt.
Drug Farm Announces First Patients Dosed in Phase 1b Clinical Trial Evaluating ALPK1 Inhibitor, DF-003 in ROSAH Syndrome
Drug Farm, a private biotechnology company utilizing genetics and artificial intelligence technologies to discover and develop innovative, immune-modulating therapies, today announced that the first human participants have been dosed in a clinical trial (NCT06395285) of DF-003 in patients with ROSAH syndrome.
Drug Farm Reports Data on Safety and Pharmacokinetics from Phase 1 First-in-Human Trial of DF-003 in Healthy Volunteers
Drug Farm, a private biotechnology company utilizing genetics and artificial intelligence technologies to discover and develop innovative, immune-modulating therapies, today announced positive results from a recently completed Phase 1 study (NCT05997641) of DF-003 in healthy volunteers. The data were presented at the American Society for Clinical Pharmacology & Therapeutics (ASCPT) meeting in Washington, DC. DF-003 is a first-in-class, immune-modulating alpha-kinase 1 (ALPK1) inhibitor that targets the root cause of the rare genetic disease, ROSAH syndrome.
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
Drug Farm, a private biotechnology company utilizing genetics and artificial intelligence technologies to discover and develop innovative, immune-modulating therapies, 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).
Drug Farm Signs Agreement with National Institutes of Health (NIH) to Develop Precision Targeted Treatment for ROSAH Syndrome
Drug Farm, a clinical-stage biopharmaceutical company developing innovative treatments targeting innate immunity, announced today the signing of a Cooperative Research and Development Agreement (CRADA) with the U.S. National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) to develop a precision targeted drug, DF-003 for the treatment of ROSAH (retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis and headache) syndrome. DF-003 is a first-in-class highly selective ALPK1 inhibitor with nanomolar potency that can cross the blood-retina barrier and has demonstrated preclinical efficacy in a transgenic ROSAH mouse model. DF-003 has completed Phase 1 evaluation in healthy subjects and will be evaluated in patients with ROSAH syndrome. Under the terms of the agreement, Drug Farm will sponsor and partner with NIAID on a clinical trial (NCT06395285) to assess the safety, pharmacokinetics and efficacy of DF-003 in people with ROSAH. “NIAID is a leader in ROSAH syndrome research and we are excited about partnering with NIAID as a first step towards developing a precision targeted drug that has potential for providing therapeutic benefit to people with ROSAH syndrome,” said Dr. Henri Lichenstein, Chief Executive Officer at Drug Farm.
Drug Farm Announces IND Clearance by U.S. FDA Enabling Phase 1b Initiation for ALPK1 Selective Kinase Inhibitor, DF-003 in ROSAH Syndrome Patients
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 alpha-kinase 1 (ALPK1) inhibitor for clinical evaluation in ROSAH syndrome patients. The trial will assess the safety, pharmacokinetics and efficacy of DF-003 in ROSAH patients.
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
Drug Farm, a private biotechnology company utilizing genetics and artificial intelligence technologies to discover and develop innovative, immune-modulating therapies, 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.
Drug Farm Receives Rare Pediatric Disease Designation from the U.S. FDA for DF-003 to Treat ROSAH Syndrome
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.
Drug Farm Doses First Patient in Part 3 of Phase 1 Chronic Hepatitis B Trial
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 Doses First Patient in Phase 1 Trial for ALPK1 Inhibitor, DF-003
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. DF-003, discovered through Drug Farms’ IDInVivo and MedChem5 platform technologies, is an investigational small molecule drug that inhibits alpha-kinase 1 (ALPK1), a key target regulating inflammation pathways that underly disease pathology in cardio-renal diseases. A gain-of-function mutation in ALPK1 also causes a rare genetic disease, ROSAH syndrome, that leads to blindness.
Drug Farm Announces IND Clearance by U.S. FDA Enabling Phase 1 Initiation for First-in-Class Oral ALPK1 Selective Kinase Inhibitor, DF-003
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.
Drug Farm Raises $27M USD Financing for Advancement of First-In-Class Hepatitis B and Cardiovascular-Renal Drugs into Clinical Trials
Drug Farm, a private biotechnology company utilizing genetics and AI technologies to discover and develop innovative, immune-modulating therapies, has raised the first round of C series financing totaling $27 million USD. 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.
Drug Farm Appoints Dr. Jeysen Yogaratnam as Chief Medical Officer
Drug Farm, a China- and US-based biotechnology company focused on developing innovative treatments targeting innate immunity for hepatitis B, cancer and autoimmune diseases, today announced the appointment of Dr. Jeysen Z. Yogaratnam MB.BCh, MRCSEd, PhD, MBA, as Chief Medical Officer (CMO).
