Assembly Biosciences Announces FDA Fast Track Designation Granted to ABI-H0731 for the Treatment of Hepatitis B Virus Infection

Assembly Biosciences (NASDAQ:ASMB) has announced that the US Food and Drug Administration (FDA) has granted fast track designation to ABI-H0731 to treat patients with chronic Hepatitis B infection.

As quoted in the press release:

ABI-H0731 is Assembly’s lead oral HBV core inhibitor, which is being evaluated in two global Phase 2a proof of concept studies that are currently enrolling patients.

The Fast Track program is intended to facilitate the development and review of drug candidates that treat serious conditions and fill an unmet medical need. A drug candidate with Fast Track designation is eligible for greater access to the FDA for the purpose of expediting the drug product candidate’s development, review and potential approval.

“More than one million individuals in the U.S. suffer from chronic Hepatitis B infection, which can progress to cirrhosis and liver cancer, eventually leading to death. Despite existing antiviral therapies, cures are rare, so the need for more effective and potentially curative treatments is tremendous,” said Uri Lopatin, MD, Chief Medical Officer of Assembly Biosciences. “We are encouraged that ABI-H0731 was granted Fast Track Designation. This will allow us to work closely with the FDA in our efforts to bring this new therapy to HBV patients as quickly as possible.”

Click here to read the full press release.