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Eiger receives FDA breakthrough therapy designation for HDV therapy
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Eiger BioPharmaceuticals received FDA breakthrough therapy designation for lonafarnib, a prenylation inhibitor designed to treat hepatitis D, according to a press release.
“There is an urgent medical need to treat HDV, the most serious form of viral hepatitis,” David Apelian, MD, PhD, chief operating officer and executive medical officer at Eiger BioPharmaceuticals, said in the release. “We look forward to collaborating with the FDA as we accelerate development of lonafarnib for HDV infection.”
The new FDA designation follows positive phase 2 clinical study data. During the phase 2 study, patients achieved an HDV RNA decline of 2 log 10 or higher and alanine aminotransferase normalization.
Lonafarnib is currently under investigation in a randomized control phase 3 study including 300 patients and 100 controls. The primary endpoint is an HDV RNA decline of 2 log 10 or higher and ALT normalization at the end of 48 weeks.
“The Phase 3 D-LIVR Study is the first-ever, global registration trial in HDV, with the potential to bring two separate, lonafarnib-based treatment regimens to HDV patients,” Apelian added in the release.
Reference: www.eigerbio.com