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Asana BioSciences is a clinical biopharmaceutical company focused on the discovery and development of new targeted therapies in immunology/inflammation and oncology. Recently, the company announced that the U.S. Food and Drug Administration (FDA) has granted ASN002 fast-track qualification for the treatment of moderate to severe endexual dermatitis. ASN002 is an experimental oral, Janus kinase (JAK) and spleen tyrosine kinase (SYK) dual-acting inhibitors.
fast-track project aims to accelerate drug development and rapid review for serious diseases to address critically unsolved medical needs in key areas. Fast-track eligibility for experimental drugs means that drug companies can interact more frequently with the FDA during the development phase, and may also receive FDA priority review after submitting a new drug application (NDA).
Asana CEO and Founder Sandeep Gupta said, "We are pleased that the FDA has granted ASN002 fast track qualification, which reflects the importance of accelerating the development of new drugs to treat challenging skin/inflammatory diseases that have a significant impact on patient life." We look forward to interacting well with the FDA throughout the development of ASN002 and accelerating the clinical development of ASN002.
, ASN002 is currently evaluating the potential for the treatment of moderate to severe endexual dermatitis in the IIb Phase RADIANT Study (NCT03654755) and the potential for the treatment of severe chronic hand eczema in another Phase II study (NCT03728504).
ASN002 is the first oral drug to be shown to improve the clinical efficacy associated with esoteric dermatitis dermatology. Data show that ASN002 can improve skin pathology, disease-related genes and inflammatory biomarkers, which are related to the clinical efficacy of patients with moderate to severe endemic dermatitis. The figures will be presented at the Inflammatory Dermatology Summit (ISDS) in Vienna on the 15th of this month.
In addition to ASN002, Asana has a number of assets under clinical development, including: (1) ASN008, a new local sodium channel blocker that is highly functionally selective for itching and pain-sensitive neurons and is currently being Development of treatment for chronic itching and pain; (2) ASN003, a selective BRAF and PI3 kinase inhibitor, the dual targeting of the RAF and PI3K pathraps has overcome and/or delayed access resistance to the selection of RAF inhibitors the potential of sex, the drug is currently being evaluated for the treatment of BRAF V600 mutant metastatic melanoma, metastatic colorectal cancer or advanced non-small cell lung cancer, as well as the treatment of advanced solid tumors with PIC3CA mutations (NCT02961283) ;( (3) ASN007, a powerful inhibitor of the extracellular signal-regulating kinases ERK1 and ERK2, which are key participants in the RAS/RAF/MEK/ERK (MAPK) signaling path, Currently, the drug is being evaluated for the treatment of patients with advanced solid tumors, including BRAF and KRAS mutant cancer (NCT03415126) ;(4) ASN004, an antibody drug association (ADC), targeting 5T4 cancer embryo antigens, which are expressed in a wide range of malignant tumors, and very limited expressions found in normal tissues, the drug's Human Phase I clinical study is scheduled to start in 2019. (Bio Valley)