EIT Pharma, a biotechnology company focused on developing therapies for infectious diseases, has presented extended analyses from its Phase 3 D-LIVR trial evaluating lonafarnib-based therapies for chronic hepatitis D (CHD) at The Liver Meeting, organised by the American Association for the Study of Liver Diseases (AASLD) in Denver, Colorado.
The D-LIVR trial, which included more than 400 participants across 21 countries, is the largest Phase 3 study conducted to date in chronic hepatitis D. The extended analyses compared lonafarnib-based treatment regimens with a placebo control and demonstrated treatment benefits following the cessation of therapy. The findings also support further development of lonafarnib-based therapy as a finite treatment regimen for patients with chronic hepatitis D.
The presentation, titled Durable and Newly Emergent Treatment Response During a 24-Week Follow-up in a Finite Lonafarnib Treatment Regimen: Extended Analyses from the Phase 3 D-LIVR Trial, was delivered by Professor Tarik Asselah, MD, PhD.
Commenting on the findings, Dr. Leen Kawas, Chief Executive Officer of EIT Pharma, said the extended analyses demonstrated the durability of treatment responses and the emergence of new composite responders following treatment cessation. She added that the findings support the potential of lonafarnib-based therapy to provide patients with chronic hepatitis D a finite treatment course with lasting benefits.
During the meeting, EIT Pharma also held scientific discussions with more than 20 US and international key opinion leaders to explore approaches to improving the management of chronic hepatitis D. Discussions included the identification of clinical markers beyond viral suppression that could help predict liver health outcomes and support patient care.
Xue Hua, PhD, Chief Development Officer of EIT Pharma, highlighted the importance of these scientific exchanges in identifying clinically relevant measures for evaluating treatment outcomes. She noted that discussions with hepatitis D experts would help guide the development of evidence demonstrating the value of the company's therapies against important clinical markers and patient outcomes.
Lonafarnib is an investigational oral therapy candidate being evaluated for chronic hepatitis D. The drug is designed to target a key step in the hepatitis D virus lifecycle and is currently the only oral therapeutic candidate in late-stage clinical development for the condition.
Lonafarnib has not been approved by the US Food and Drug Administration or any other regulatory authority for the treatment of chronic hepatitis D. Its safety and efficacy for this indication have not been established.
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