Saturday, Gilead Sciences Inc (NASDAQ:GILD), following the recent acquisition of CymaBay Therapeutics Inc, announced interim results from the ongoing ASSURE study.
The ASSURE study is an open-label study to evaluate the long-term safety and tolerability of seladelpar in people with primary biliary cholangitis (PBC) who have already participated in other PBC clinical trials of seladelpar. The study is currently enrolling up to 500 people.
Also Read: Gilead's Aggressive Push Beyond HIV Treatments – Plans To Increase Cancer-Focused CAR-T Treatment Production.
The study demonstrated that the treatment with seladelpar led to improvements in markers of cholestasis and reduced inflammation.
Additional findings demonstrate that seladelpar can help reduce pruritus (itch) in primary biliary cholangitis patients.
70% of the 148 patients who completed 12 months of treatment achieved the clinically meaningful composite response endpoint.
Among those receiving seladelpar, 37% experienced alkaline phosphatase (ALP) normalization, with a mean ALP change from baseline of -44% (-144.4 U/L).
Of the 20 patients who completed 24 months of treatment, 70% achieved the composite response endpoint, and 25% experienced ALP normalization.
Seladelpar also reduced other important biomarkers of liver injury, including TB, gamma-glutamyl transferase (GGT), and alanine aminotransferase (ALT) levels by 9%, 36%, and 25% from baseline, respectively.
There were no treatment-related serious adverse events in the study.
Seladelpar was generally well tolerated, with discontinuation due to adverse events occurring in 4.6% of patients.
In the 60 patients with moderate-to-severe pruritus, a rapid improvement in pruritus was observed at Month 1.
By Month 6 the patients reported a mean reduction of 3.5 points, and this impact was sustained through Month 12.
A New Drug Application for seladelpar for PBC has been accepted for priority review by the FDA, with an anticipated decision in August 2024.
Price Action: GILD shares are down 0.44% at $67.42 at last check Monday.
Photo via Shutterstock