Assembly Biosciences Inc. (NASDAQ: ASMB) stock gained by 2.63% at last close whereas the ASMB stock price declines by 15.38% in the after-hours trading session. Assembly Bio is a medical biotechnology firm dedicated to developing restricted and curative hepatitis B virus (HBV) treatments for the world’s 270 million individuals living with the illness.
ASMB stock’ Current Development
Following the finding of increased ALT values consistent with drug-induced hepatotoxicity in an ongoing Phase 2 study, Assembly Biosciences has decided to stop developing ABI-H2158 (2158).
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The Phase 2 clinical trial for 2158 is a multi-center, randomized, placebo-controlled trial in treatment-naive individuals with chronic hepatitis B infection without cirrhosis who have HBeAg positive or negative HBeAg. For up to 72 weeks, a total of 88 patients were enrolled and randomized three to one to get either 300 mg 2158 with entecavir or placebo plus entecavir once daily.
Two of the 2158 patients in the trial had Grade 4 ALT increases, which led to the drug’s termination. Two more patients who received 2158 experienced ALT elevations of Grade 3. There have been no other possible reasons for the ALT increases, and these four individuals are still being cautiously followed. The business has informed the US Food and Drug Administration (FDA) of the findings and has voluntarily decided to stop developing 2158 and the Phase 2 trial. After informing the FDA of the company’s decision, the FDA announced that 2158 will be placed on clinical hold as well.
Beyond core inhibition, Assembly Bio will keep pursuing a research pipeline of projects concentrating on HBV antiviral mechanisms. Assembly Bio is working on a new family of HBV core protein modulators alongside Door Pharma that have the power to interact with viral nucleic acid, including cccDNA transcription. In addition, the business is doing exclusive internal research on two new targets.
Assembly Bio intends to be able to accelerate the development of its next-generation assets more swiftly by shifting resources previously allocated to the 2158 program and Phase 2 investigations, while also extending its financial runway until the second half of 2023.