Endeavor BioMedicines Receives Orphan Drug Designation from the U.S. Food and Drug Administration and European Commission for Taladegib (ENV-101) for the Treatment of Idiopathic Pulmonary Fibrosis
'Receiving Orphan Drug Designation for taladegib in both the United States and European Union underscores the significant unmet medical need for patients with IPF,' said Lisa Lancaster, M.D., Chief Medical Officer, Endeavor BioMedicines. 'We are encouraged by the potential of taladegib to reverse the course of disease across multiple measures of IPF, which is a major step forward from current standard-of-care. I am very proud of our team, which is executing the Phase 2b WHISTLE-PF trial with a remarkable sense of purpose, driven by our mission to push the boundaries of what is possible and restore hope to patients and their families.'
Orphan Drug Designation in the European Union (EU) is granted by the EC based on a positive opinion from the European Medicines Agency's Committee for Orphan Medicinal Products. It is intended to encourage the development of drugs that may provide significant benefit to patients suffering from rare, life-threatening diseases with a prevalence of not more than five in 10,000 in the EU. The designation provides special incentives for sponsors, including eligibility for protocol assistance and exemptions or reductions in certain regulatory fees, as well as 10 years of marketing exclusivity if the product is approved for the designated use.
The FDA grants Orphan Drug Designation to drugs and biologics intended for the treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the U.S. Orphan Drug Designation provides sponsors certain benefits, including financial incentives to support clinical development and the potential for up to seven years of market exclusivity for the drug for the designated orphan indication in the U.S. if the drug is ultimately approved for that use.
About the WHISTLE-PF Trial
The Phase 2b WHISTLE-PF clinical trial is a global, randomized, placebo-controlled study evaluating the therapeutic potential of taladegib in individuals with IPF (NCT06422884). The WHISTLE-PF trial will evaluate the efficacy of a range of taladegib doses through 24 weeks of treatment, characterize the investigational compound's safety and tolerability, assess its effect on patient reported outcomes and its effects on lung function, lung capacity and lung fibrosis as measured by chest high-resolution computed tomography.
About Taladegib
Endeavor's investigational drug taladegib is a Hedgehog (Hh) signaling pathway inhibitor. By binding to and inhibiting a key receptor in the Hh pathway, taladegib stops the abnormal accumulation of myofibroblasts that cause fibrosis. This may resolve the excessive wound-healing process seen in pulmonary fibrosis, improving lung volume and function.
About Idiopathic Pulmonary Fibrosis
IPF is a chronic, progressive lung disease that affects more than 150,000 adults in the United States. Although the exact cause of IPF is unknown, various environmental factors can deliver repeated injuries to lung cells that trigger abnormal wound-healing processes and life-threatening lung scarring. IPF is a chronic disease with limited treatment options and a very poor prognosis. The average life expectancy is three to five years after diagnosis.
About Endeavor BioMedicines
Endeavor BioMedicines is a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases. Endeavor's lead candidate, taladegib (ENV-101), is an inhibitor of the Hedgehog signaling pathway in development for fibrotic lung diseases, including idiopathic pulmonary fibrosis (IPF). More information is available at www.endeavorbiomedicines.com and on LinkedIn or X.
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