Partnering for Progress: Leveraging Advocacy Groups to Drive Awareness and Participation in IPF Trials

PE: Are there any ongoing collaborations with patient advocacy groups or organizations to raise awareness of IPF or facilitate patient participation in the clinical trial?

Hood: We’re working with a number of different pulmonary fibrosis advocacy groups right now, both in the United States and internationally. These include PF Warriors, the Pulmonary Fibrosis Foundation United States, Foundation Australia, and EUPF. We really need to do this, because even while IPF is a rare disease with around 150,000 patients in the United States, it’s not common. You have a patient on every corner It's kind of weird, because if you talk to people, it doesn't seem like anyone's more than one to two degrees of separation away from an IPF patient. You really need to use the patient advocacy groups to let them know about the trial and bring the patients in and give them an opportunity to be on this drug. Our hope is that because the efficacy data is superior to current standard of care and standard of care is generally not very well tolerated, and this drug seems to be better tolerated, even more patients will come out, get on the study, and benefit from the drug. Advocacy groups can help with that.

Full Interview Summary: The initiation of the WHISTLE PF trial for ENV-101 aligns with the company’s broader strategic goals by advancing its priority of addressing idiopathic pulmonary fibrosis (IPF) with transformative therapies. ENV-101 targets the Hedgehog signaling pathway, directly addressing the disease’s underlying pathology by reducing fibrosis and potentially reversing lung damage, distinguishing it from current IPF treatments that only slow disease progression.

Phase IIa trials have demonstrated both clinical and statistical significance in improving lung function, structure, and reducing fibrosis. With a favorable safety profile observed across 230 patients, including oncology studies, the WHISTLE PF trial will further validate these findings in a larger, more diverse population. The Phase IIb trial will explore additional lower doses to optimize efficacy and tolerability while permitting standard-of-care therapies, ensuring comprehensive data collection. Safety monitoring will include an independent review board to oversee adverse events.

The company is also collaborating with patient advocacy organizations like the Pulmonary Fibrosis Foundation (USA), PF Warriors, and international groups in Australia, Europe, and the UK. Given IPF’s life-threatening nature and the drug’s promise to outperform standard care in both efficacy and tolerability, these partnerships are important for patient education and awareness.

While regulatory timelines remain uncertain, the company is committed to expediting the process, acknowledging the severe prognosis of IPF. The potential for accelerated approval, typically rare in pulmonary conditions, underscores the drug’s unique position as a game-changer for this devastating disease.