SAN DIEGO - Viking Therapeutics, Inc. (NASDAQ: NASDAQ:VKTX) has reported positive 52-week histologic data from its Phase 2b VOYAGE study of VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH), a clinical-stage biopharmaceutical company announced Monday. The study met its primary endpoint, with VK2809-treated patients experiencing statistically significant reductions in liver fat content from baseline to Week 12 compared with placebo.
Secondary endpoints included NASH resolution with no worsening of fibrosis and improvement in fibrosis without worsening of NASH. Up to 75% of patients treated with VK2809 achieved NASH resolution, significantly higher than the 29% for placebo. Additionally, up to 57% of patients showed a ≥1-stage improvement in fibrosis, compared to 34% for the placebo group.
The study also looked at the proportion of patients experiencing both resolution of NASH and improvement in fibrosis, with VK2809-treated patients demonstrating improvement ranging from 40% to 50%, compared with 20% for placebo.
Safety and tolerability of VK2809 were consistent with prior data, with most treatment-related adverse events being mild or moderate. The study's results support the potential of VK2809 as a treatment for NASH and fibrosis, with the company planning to share full results at a future medical meeting.
Viking's CEO, Brian Lian, Ph.D., highlighted the compound's efficacy and tolerability, noting the support for thyroid hormone receptor beta agonism as an important mediator of the disease. In addition to NASH resolution, VK2809 treatment resulted in statistically significant reductions in plasma lipids, which may offer a cardio-protective benefit.
The VOYAGE study was a randomized, double-blind, placebo-controlled trial designed to assess the efficacy, safety, and tolerability of VK2809 over 52 weeks. Viking will discuss the study's top-line results in a conference call scheduled for today at 8:00 a.m. ET.
VK2809 is a novel liver-selective thyroid hormone receptor beta agonist that has shown promise in a range of lipid disorders. Viking Therapeutics is focused on developing therapies for metabolic and endocrine disorders, with VK2809 being one of the compounds currently in clinical trials.
This article is based on a press release statement from Viking Therapeutics.
In other recent news, Viking Therapeutics has made significant strides in its drug development. The company announced positive results from its Phase 2 VENTURE study of VK2735, a drug aimed at treating obesity, during its First Quarter 2024 earnings call. The study met its primary and secondary endpoints, showing significant reductions in body weight.
Truist Securities maintained a Buy rating on Viking Therapeutics, with a steady price target of $120.00, following the release of this new clinical trial data. The firm compared this data with that of competitor Roche's drug CT-388, suggesting that VK2735 demonstrated superior efficacy.
Furthermore, Viking Therapeutics reported successful outcomes from a Phase 1 trial of an oral tablet formulation of VK2735 and plans to proceed with further development later in the year. The company has also completed a public stock offering, raising approximately $630 million, strengthening its financial position.
InvestingPro Insights
As Viking Therapeutics (NASDAQ: VKTX) makes headlines with its promising clinical results for VK2809, investors are keenly observing the company's financial health and market performance. According to InvestingPro, Viking Therapeutics holds a market capitalization of $6.16 billion, signifying its substantial size in the biopharmaceutical sector. Despite challenging market conditions, the company's stock has seen an impressive one-year price total return of 179.49%, reflecting strong investor confidence in its long-term prospects.
However, InvestingPro data also shows a high Price / Book multiple of 7.35 as of the last twelve months leading up to Q1 2024, suggesting that the stock might be trading at a premium compared to its book value. Additionally, the company's P/E Ratio stands at -59.83, indicating that investors are currently valuing the company's growth prospects rather than its current earnings.
InvestingPro Tips for VKTX reveal that analysts have tempered their earnings expectations, with four analysts revising their earnings downwards for the upcoming period. This could be a point of concern for potential investors, as it may reflect uncertainties about the company's future profitability. Moreover, VKTX does not pay dividends, which might influence the investment decisions of income-focused shareholders.
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