Aligos completes enrollment in phase 2 hepatitis B study

Aligos completes enrollment in phase 2 hepatitis B study

Gold slides as U.S.-Iran conflict lifts oil, hawkish Fed bets grow SOUTH SAN FRANCISCO, Calif. - Aligos Therapeutics Inc. (NASDAQ:ALGS) announced Monday it has completed enrollment in both parts of its Phase 2 B-SUPREME study evaluating pevifoscorvir sodium for chronic hepatitis B virus infection. The company enrolled 131 HBeAg+ participants in Part 1a and 114 HBeAg- participants in Part 2a, according to a press release statement. The enrollment in Part 1a exceeded the planned target, eliminating the need for a second interim analysis for sample size re-estimation.

The stock surged 13% over the past week following the enrollment announcement, though shares remain down 29% year-to-date. With a market capitalization of $41 million, the clinical-stage biotech holds more cash than debt on its balance sheet, a critical factor as it advances through costly late-stage trials. Topline safety and efficacy data from the study are expected in late third quarter of 2027.

The B-SUPREME study is a randomized, double-blind, active-controlled multicenter trial comparing pevifoscorvir sodium monotherapy with tenofovir disoproxil fumarate in approximately 250 untreated adult subjects with chronic HBV infection over 48 weeks. The primary endpoint for HBeAg+ participants is HBV DNA below 10 IU/mL, while the HBeAg- part measures HBV DNA below 10 IU/mL with target not detected. According to InvestingPro analysis, the stock appears undervalued at current levels, with additional insights available through the platform’s comprehensive Fair Value assessment and over a dozen ProTips for deeper analysis.

Pevifoscorvir sodium is an oral small molecule capsid assembly modulator derived from intellectual property licensed from Emory University. Phase 1 studies showed the compound was well-tolerated with no safety signals and demonstrated antiviral activity. In longer-term Phase 1 studies, pevifoscorvir sodium 300mg daily for up to 96 weeks showed sustained reductions in HBV DNA, RNA, and various antigens.

The compound has received acknowledgment from the FDA, EMA, and China’s NMPA for a regulatory path utilizing the chronic suppressive pathway for subsequent studies. Chronic hepatitis B affects approximately 240 million patients worldwide, with about 1 million new infections annually. The World Health Organization reported that complications from the infection resulted in approximately 1.1 million deaths in 2024.

In other recent news, Aligos Therapeutics has made significant strides with its hepatitis B drug candidate, pevifoscorvir sodium. The company received a $25 million upfront payment from Xiamen Amoytop Biotech Co., Ltd. as part of an exclusive licensing agreement for the drug in Greater China. This licensing deal also grants Amoytop exclusive rights to develop and commercialize the drug in that region, while Aligos retains rights in the U.S., Europe, South Korea, Japan, and other markets.

The drug has received Breakthrough Therapy Designation from China’s National Medical Products Administration, which could expedite its review process. Analyst firms have shown confidence in Aligos Therapeutics, with H.C. Wainwright reiterating a Buy rating and setting a price target of $50.00, emphasizing the potential of pevifoscorvir sodium. Cantor Fitzgerald also reiterated an Overweight rating, citing positive hepatitis B treatment data.

Meanwhile, Lake Street initiated coverage with a Buy rating and a $45.00 price target, highlighting sales projections for the drug. These developments reflect growing interest and optimism in Aligos’ pipeline and strategic partnerships.