First IPF Patient Dosed with Pamrevlumab in Ongoing ZEPHYRUS Phase 3 Trial
A patient with idiopathic pulmonary fibrosis (IPF), enrolled in the ZEPHYRUS Phase 3 clinical study, has been dosed with FibroGen’s investigational therapy pamrevlumab, the company announced.
Still recruiting participants, the ZEPHYRUS study (NCT03955146) is expected to enroll approximately 565 IPF patients who have not responded to, or are intolerant to treatment with IPF-approved therapies, such as Ofev (nintedanib) and Esbriet (pirfenidone).
Participants will be randomly assigned to receive pamrevlumab (30 mg/kg) or a placebo by intravenous infusion every three weeks, for a total treatment period of 48 weeks.
Over the total 52 weeks of the trial, researchers will assess the impact of pamrevlumab on participants’ lung function, as determined by changes in forced vital capacity (FVC). Those results will be compared with baseline — or the assessment at the start of the study — and with findings from the placebo-treated group.
All participants who complete the yearlong study may be eligible to continue treatment with pamrevlumab in a separate open-label extension study.
For additional information about the ZEPHYRUS trial, including the locations where it is being conducted, please visit its webpage here.
“IPF patients today face a poor prognosis and must endure devastating losses in lung function and the quality of their lives,” Elias Kouchakji, MD, senior vice president of clinical development and drug safety at FibroGen, said in a press release. “Pamrevlumab represents an innovative therapeutic approach to treating IPF.”
Pamrevlumab, formerly known as FG-3019, is an engineered antibody that was designed to inhibit the activity of connective tissue growth factor (CTGF). CTGF is known to contribute to the progressive and excessive tissue scarring characteristic of IPF and other fibrotic diseases.
The U.S. Food and Drug Administration (FDA) has granted pamrevlumab Orphan Drug and Fast Track designations.
The treatment’s safety and efficacy has already been demonstrated by the results of two previous Phase 2 trials – PRAISE (NCT01890265) and Gorina (NCT01262001).
These studies showed that intravenous delivery of 30 mg/kg pamrevlumab over 48 weeks had the potential to halt lung fibrosis progression in patients with mild-to-moderate IPF, in comparison with placebo. This positive result was associated with a reduced decline rate in FVC during the study period.
“There is an urgent need for new treatments that will help IPF patients, who have limited or no treatment options,” said Luca Richeldi, MD, PhD, head of the division of pulmonary medicine at Agostino Gemelli University Hospital of the Catholic University of the Sacred Heart in Rome.
“Pamrevlumab has demonstrated positive efficacy and safety results with statistically significant treatment effects in slowing IPF progression as well as promising findings in improving lung function and lung fibrosis in prior studies,” Richeldi added. “It is exciting to see pamrevlumab, as a potential new therapy, begin the ZEPHYRUS Phase 3 study.”
