Kirkland’s EIT Pharma Shares Milestone for Drug Treating Chronic Hepatitis D

Kirkland-based EIT Pharma Inc., a biotechnology company developing therapies for infectious diseases, on Tuesday said the U.S. Food and Drug Administration has accepted for review its New Drug Application, or NDA, for Lonafarnib for treatment of chronic hepatitis D.

Chronic hepatitis D, or CHD, is a life-threatening liver disease caused by hepatitis D virus, HDV, in people who already have hepatitis B virus infection. CHD can progress rapidly to cirrhosis, liver failure, liver cancer, and death, according to a news release from EIT Pharma.

Treatment options remain limited, with no current FDA-approved oral therapies for CHD in the United States, it added.

“FDA acceptance of our NDA is an important milestone in our mission to bring a potential new oral treatment to people living with chronic hepatitis D,” EIT Pharma CEO Leen Kawas said in the release. “We’re grateful to the patients, investigators, and researchers whose commitment to the D-LIVR study made this milestone possible.”

The D-LIVR study for Lonafarnib was the largest clinical trial conducted to date in chronic hepatitis D. It enrolled more than 400 participants across 21 countries, according to EIT and a separate news release from Propel Bio Partners LP, an equity investment firm with offices in Seattle and Los Angeles focused on helping entrepreneurial life-science companies advance technologies and therapies.

If ultimately approved by the FDA, Lonafarnib’s oral administration, room-temperature storage, and potential for long-term survival may offer practical advantages for people with CHD and for healthcare providers who consider treatment burden, duration and accessibility, and long-term clinical benefit when evaluating treatment options, EIT’s release said.

Lonafarnib is an investigational first-in-class oral CHD therapy candidate with a unique mechanism of action, according to the company.

Following EIT Pharma’s acquisition of the late-stage program in 2024, it worked with regulators and scientific and medical collaborators to complete the NDA submission. EIT Pharma will continue to work collaboratively with the FDA during its review and will continue to prepare for the commercialization of Lonafarnib, post-approval.

“Patients living with chronic hepatitis D urgently need novel therapies that target distinct steps in the HDV lifecycle,” Dr. Jeffrey Glenn, co-founder of EIT Pharma and professor of medicine at Stanford University, added in EIT’s release. “The FDA’s acceptance of the NDA is an important first step towards getting patients with CHD a new treatment option for this serious, life-threatening disease, and we look forward to working closely with the FDA throughout the review process.”

In the release from Propel — which provides its portfolio companies access to medical experts, operational advisers, and service providers in addition to a financial commitment — Kawas said she was honored to lead EIT in what she called a pivotal moment for the company.

“The people living with chronic hepatitis D have far too few treatment options and no patient should be left behind,” Kawas said. “EIT Pharma’s programs sit exactly where I believe this industry should focus: where the unmet need is high, the innovation is relentless, the science is rigorous and the potential patient impact is meaningful. It is our mission to progress these therapies toward the patients waiting for them.”

EIT also is advancing Lambda, its Phase 2 investigational treatment for severe acute viral respiratory infections, according to Propel.