SAN DIEGO - Viking Therapeutics, Inc. ('Viking') (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced its financial results for the third quarter and nine months ended September 30, 2023, and provided an update on its clinical pipeline and other corporate developments.

Highlights from the Quarter Ended September 30, 2023, and Other Recent Events: 'The third quarter of 2023 has been an exciting period for Viking,' stated Brian Lian, Ph.D., chief executive officer of Viking. 'We filed an IND for a Phase 2 trial for our newest program, VK2735, for obesity, and subsequently initiated the Phase 2 VENTURE study to assess the efficacy of this compound over a 13-week treatment period. As we recently announced, the high level of interest in this trial allowed us to enroll the study more rapidly than anticipated, and to exceed our original enrollment target. We also continued enrollment in a Phase 1 study evaluating an oral formulation of VK2735 to determine its preliminary safety, tolerability, and pharmacokinetic and pharmacodynamic profile. We expect to report data from both of these studies in the first half of 2024. We also continued to advance our best-in-class thyroid hormone receptor beta agonist, VK2809, for NASH and fibrosis, and remain on track to report the histology results from the 52-week VOYAGE study in the first half of next year. As we advance our pipeline, we remain disciplined with our finances and maintain a strong balance sheet of approximately $376 million. We expect this to provide operating runway through value-creating milestones for each of our programs.'

Pipeline and Recent Corporate Highlights

Initiated Phase 2 VENTURE Trial Evaluating Dual GLP-1/GIP Agonist VK2735 in Patients with Obesity; Results Expected 1H24. VK2735 is a wholly owned dual agonist of the glucagon like peptide-1, or GLP-1 receptor, and the glucose dependent insulinotropic polypeptide, or GIP receptor, for the potential treatment of various metabolic disorders such as obesity, non-alcoholic steatohepatitis (NASH), and certain rare disorders.

During the first quarter of 2023, the company announced positive results from a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial of VK2735, which demonstrated that treatment with VK2735 was safe and well-tolerated following weekly dosing for 28 days in healthy obese volunteers. In the SAD portion of the Phase 1 study, VK2735 demonstrated promising safety and tolerability, as well as a predictable pharmacokinetic profile. Following single subcutaneous doses, VK2735 demonstrated a half-life of approximately 170 to 250 hours and excellent therapeutic exposures.

In the 28-day MAD portion of the study, VK2735 demonstrated encouraging safety and tolerability, and positive signs of clinical activity. All cohorts receiving VK2735 experienced reductions in mean body weight from baseline, ranging up to 7.8%. Cohorts receiving VK2735 also demonstrated reductions in mean body weight relative to placebo, ranging up to 6.0%. Statistically significant differences compared to placebo were maintained or improved at the Day 43 follow-up time point, 21 days after the last dose of VK2735 was administered.

VK2735 also demonstrated encouraging safety and tolerability following repeated dosing. The majority of observed adverse events (98%) were reported as mild or moderate, and the majority of gastrointestinal (GI)-related adverse events (99%) were also reported as mild or moderate.

These results were featured earlier this month in an oral presentation at ObesityWeek, the annual meeting of the Obesity Society. The presentation highlighted the previously reported safety, tolerability, and weight loss findings, as well as new data demonstrating VK2735's impact on liver fat and plasma lipids. Notably, after four weekly doses of VK2735, subjects in the Phase 1 trial reported liver fat reductions of up to 47% from baseline (placebo-adjusted, p

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