New medicine for rare diseases! Fda grants powerful ATX inhibitor BBT-887 treatment for idiotrexic pulmonary fibrosis (IPF) orphans:
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Last Update: 2021-02-16
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Source: Internet
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Author: User
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Biotherapeutics is a clinical biopharmaceutical technology company headquartered in South Korea City with a JLABS@TMC Innovation Center division in Houston, Texas. Recently, the company announced that the U.S. Food and Drug Administration (FDA) has awarded BBT-877 to treat idiotreatable pulmonary fibrosis (IPF) orphan drug qualification.
is used to prevent, treat and diagnose rare diseases, which are the general term for a very low incidence of diseases, also known as "orphan diseases". In the U.S., rare diseases are disease types with fewer than 200,000 people, and incentives for the development of rare disease drugs include incentives for clinical development, such as tax credits related to clinical trial costs, FDA user fee deductions, FDA assistance in clinical trial design, and a seven-year market exclusive period after the drug is approved for market.
BBT-887 is a powerful, best-in-class self-secreting motor factor (Autotaxin, ATX) inhibitor, and ATX is an enzyme involved in inflammation and fibrosis by producing lipid signal molecules. The early compounds of BBT-887 were originally discovered by LegoChem Biosciences, a South Korean biotech company. In 2017, Bridge Biotherapeutics acquired the exclusive global license to further develop the drug.
August 2018, Bridge Biotherapeutics presented the results of the preclinical study of BBT-877 at the IF Summit, which attracted the interest and concern of respiratory experts about the effectiveness and safety of the drug candidate. Data show that the BBT-877 may be the best compound of its kind compared to the compounds currently under development.
next month, Bridge Biotherapeutics will launch a Phase I study of BBT-887 in the United States to assess the drug's safety, toerability, pharmacodynamics and pharmacoetics among healthy volunteers. The study will be divided into two phases: a single incremental dose (SAD) phase of five queues and a multiple incremental dose (MAD) phase of three queues. The main completion time is expected to be the end of 2019.
BBT-877 is the second molecule that Bridge Biotherapeutics has been approved for clinical study by the U.S. FDA, and another molecule, BBT-401, is currently in Phase II clinical practice, the first anti-ubilin-connecting enzyme Pellino-1 compound for the treatment of ulcerative colitis, and is expected to be given to selective patient groups for the first time in February. (Bio Valley)
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