Endeavor BioMedicinesENV-101 (Taladegib): A Safe and Efficacious Disease-Modifying Agent In Treatment of Idiopathic Pulmonary Fibrosis
- ENV-101 is a safe and well-tolerated, unique, disease-modifying agent in the treatment of IPF.
- ENV-101 not only improved lung function but also reversed signs of fibrosis in patients with IPF over 12 weeks.
The Latest
A randomized, double-blinded, placebo-controlled phase 2a clinical trial funded by Endeavor BioMedicines investigated the safety and efficacy of ENV-101 (or taladegib) in the treatment of idiopathic pulmonary fibrosis (IPF). Forty-one patients were randomized between a treatment and a placebo arm and were monitored over 12 weeks. In addition to safety, the trial also investigated lung function as a secondary objective. Researchers found that ENV-101 was not only safe and well tolerated by patients but also improved overall lung function and reversed signs of fibrosis. The most common adverse events (AE) were alterations in taste, muscle spasms, and hair loss. These AEs were mild to moderate in severity. With the success seen in this trial, Endeavor is now preparing to initiate a phase 2b trial which will expand to include progressive pulmonary fibrosis as a potential treatment target for ENV-101.
Physician’s Perspective
IPF falls under the umbrella of interstitial lung disease (ILD) and is one of the most common ILDs. ILD is characterized by progressive inflammation and fibrosis of lung tissue. IPF is a chronic disease that has historically been considered irreversible and devastating. There are typically 1 in 10000 cases of IPF per year. Symptoms include shortness of breath on exertion, dry cough, and constitutional symptoms. While surgical biopsy is the gold standard for diagnosis, IPF can be diagnosed by history and high-resolution CT scan findings. Presently, the treatment for IPF largely involves symptomatic relief. Antifibrotic therapy in the form of pirfenidone and nintedanib has shown improvement in lung function and reduction in mortality. However, the prognosis of IPF remains poor, with respiratory failure typically occurring within 3-7 years of diagnosis. With results suggesting Endeavor BioMedicines’ ENV-101 not only improves lung function but also reverses signs of fibrosis, ENV-101 may prove to be a game changer in the treatment of IPF.
Molecular Target of Therapy
ENV-101 is an orally administered medication that inhibits the hedgehog signaling pathway. This molecular pathway is normally involved in the body’s healing process. In IPF, an abnormal activation of this pathway leads to the development of fibrosis. Targeting this pathway is a unique and novel approach to the treatment of IPF.
Company History
Endeavor BioMedicines is a biotechnology company focused primarily on clinical-stage research and the development of treatments for life-threatening and medically intractable diseases. In addition to their continued work on ENV-101, the company also hopes to move its second candidate, ENV-501, into a phase 1 trial. ENV-501 is a monoclonal antibody proposed for the treatment of HER3+ cancers.
Further reading: https://clinicaltrials.gov/study/NCT04968574
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