Assembly Bio ditches hepatitis B drug on liver toxicity concerns in mid-stage test
Bay Area microcap biotech Assembly Bio had big plans for a lead hepatitis B drug, but safety red flags have now led the company to ditch the program altogether.
Assembly Bio has discontinued development of ABI-H2158, its candidate to treat hepatitis B, after observing elevated levels of alanine transaminase (ALT) — a sign of liver toxicity — in Phase II patients, the biotech said Wednesday.
The Phase II trial tested ABI-H2158 in 88 treatment-naïve patients with HBeAg positive or HBeAg negative chronic hepatitis B infection without cirrhosis, with patients randomized to receive either a 300 mg dose of 2158 plus entecavir or placebo plus entecavir once daily for up to 72 weeks.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 124,400+ biopharma pros reading Endpoints daily — and it's free.