SOUTH SAN FRANCISCO - Aligos Therapeutics, Inc. (NASDAQ: ALGS), a biopharmaceutical company, revealed positive results from its Phase 2a HERALD study on ALG-055009, a drug intended for the treatment of metabolic-dysfunction associated steatohepatitis (MASH). The study met its primary endpoint, demonstrating statistically significant reductions in liver fat content after a 12-week treatment period.
The double-blind, placebo-controlled trial enrolled 102 subjects with presumed MASH and varying stages of liver fibrosis. Participants received one of four doses of ALG-055009 or a placebo orally once daily. The 0.5 mg to 0.9 mg dose groups showed up to a 46.2% median relative reduction in liver fat as measured by MRI-PDFF, with 70% of subjects achieving a greater than 30% reduction.
Additionally, the medication was reported to be well-tolerated, with no serious adverse events or dose reductions. Gastrointestinal-related adverse events were comparable to placebo, with less incidence of diarrhea. Significant reductions in atherogenic lipids were also observed, including LDL-C, lipoprotein (a), and apolipoprotein B.
Dr. Rohit Loomba of the University of California, San Diego, highlighted the importance of the drug's potency and pharmacokinetics (PK) in improving patient outcomes. He noted the potential benefits for MASH resolution, fibrosis improvement, and cardiovascular risk reduction, pending confirmation in future trials.
Aligos' CEO, Lawrence Blatt, Ph.D., MBA, expressed that the study's results affirm ALG-055009's potential as a best-in-class THR-β agonist, with a favorable tolerability profile that could help patients adhere to long-term treatment. The company is considering various funding options for further development and plans to prepare for a Phase 2b study by mid-2025.
The company will present additional data at a scientific meeting later in the year and has hosted a conference call and webcast to discuss the findings. The information in this article is based on a press release statement from Aligos Therapeutics.
In other recent news, Aligos Therapeutics is set to release topline results from its Phase 2a HERALD study of ALG-055009, a thyroid hormone receptor beta agonist in treating metabolic-dysfunction associated steatohepatitis. Aligos also reported promising Phase 1 results for its pan-coronavirus protease inhibitor, ALG-097558. Moreover, the company has regained compliance with Nasdaq's minimum bid price requirement, averting the risk of delisting.
Analysts have also been active in their assessments of Aligos. Piper Sandler reaffirmed its Overweight rating and $175.00 price target for the company, emphasizing the potential of its ALG-000184, a candidate for chronic hepatitis B treatment. H.C. Wainwright initiated coverage on Aligos Therapeutics with a Buy rating, highlighting the potential of ALG-055009 in a Phase 2a study and ALG-000184 in a Phase 1b trial.
These recent developments reflect the ongoing efforts of Aligos Therapeutics to advance its clinical programs and contribute to better patient outcomes through its therapeutic developments. The forthcoming results of the Phase 2a study will provide investors with insights into the potential of ALG-055009 as a treatment option for MASH.
InvestingPro Insights
Aligos Therapeutics, Inc. (NASDAQ: ALGS) has recently shared promising clinical trial results for their drug ALG-055009, which could potentially be a breakthrough in treating metabolic-dysfunction associated steatohepatitis (MASH). As investors and stakeholders look at the company's prospects, certain financial metrics and analyst insights from InvestingPro are worth considering.
From a financial standpoint, Aligos Therapeutics currently holds a market capitalization of $87.29 million, which is reflective of investor sentiment and the company's perceived potential. Despite the positive clinical trial outcomes, the company's revenue has seen a significant decline over the last twelve months as of Q2 2024, with a decrease of 53.82%. This contraction in revenue highlights potential challenges the company faces in its operational growth.
InvestingPro Tips suggest that Aligos is trading at a low revenue valuation multiple, which could indicate that the market has yet to fully recognize the potential value of its drug pipeline. Additionally, the company has been quickly burning through cash, a common scenario for biopharmaceutical firms in the drug development stage. This rapid cash burn may necessitate further funding strategies, as the company plans for its next phase of clinical trials.
Investors should note that despite the recent stock price volatility, Aligos has seen a strong return over the last three months, with a 34.66% price total return. This could be indicative of growing investor confidence following the recent clinical trial news. However, analysts have expressed concerns, noting that Aligos suffers from weak gross profit margins and do not anticipate the company will be profitable this year.
For those looking to delve deeper into Aligos' financial health and future prospects, there are additional InvestingPro Tips available at https://www.investing.com/pro/ALGS, providing a comprehensive analysis for informed decision-making.
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