• Company's Receptor Co-Agonists Demonstrate Potent Body Weight Reductions, Decreased Food Intake and Improved Metabolic Profile in Healthy Rats and Diet-Induced Obese Mice

SAN DIEGO, June 24, 2024 /PRNewswire/ -- 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 the presentation of preclinical data from a series of internally developed dual agonists of the amylin and calcitonin receptors at the 84^th Scientific Sessions of the American Diabetes Association.  The presentation highlights the effects of treatment on body weight, food intake and metabolic profile in healthy rats and diet-induced obese (DIO) mice as compared to control cohorts treated with vehicle or the dual amylin and calcitonin receptor agonist cagrilintide.  The studies were summarized in a poster presentation at the annual scientific conference of the American Diabetes Association, being held June 21-24, 2024, in Orlando, Florida. 

The study results demonstrate that Viking's series of dual amylin and calcitonin receptor agonists (DACRAs) reduced food intake in lean rats in the period from 0 – 72 hours following a single subcutaneous dosing.  At 72 hours following a single subcutaneous dose, Viking's novel compounds resulted in up to 8% body weight reductions compared to vehicle-treated animals.

In a DIO mouse model, treatment with Viking's series of co-agonists for 24 days resulted in body weight reductions that were comparable to those achieved in cagrilintide-treated animals.  Additionally, improvements in key metabolic markers, including blood glucose levels, were observed in DIO mice treated with the company's compounds for the 24-day time period.

Highlights from poster 2024-LB-5842: Novel Amylin and Calcitonin Receptor Co-Agonists Reduce Food Intake and Body Weight in Rodents.

• Viking DACRAs demonstrated EC₅₀ values ranging from low nM to micromolar on the human amylin 3 receptor and a similar range of potencies on the human calcitonin receptor.
• Treatment with single doses of Viking DACRAs resulted in up to 8% mean reductions in body weight in lean rats after 72 hours.
• Treatment of DIO mice for 24 days with Viking DACRA compounds demonstrated up to 10% weight loss from baseline (p<0.05 vs. baseline).
• Viking DACRA compounds demonstrated up to 24% reductions in blood glucose in DIO mice after 24 days (p<0.05 vs. baseline and cagrilintide control).

The results of these and other preclinical studies provide the rationale for Viking's continued advancement of its internal dual amylin and calcitonin receptor agonist development program.

"The amylin receptor plays an important role in food intake and metabolic control, making it an attractive target for therapeutic intervention in obesity," said Brian Lian, Ph.D., chief executive officer of Viking.  "These data demonstrate the potent activity of a series of novel, internally developed, amylin and calcitonin dual agonists and represent an exciting expansion of our pipeline in obesity and metabolic diseases.  This program provides Viking with additional opportunities to develop novel, differentiated therapies for obesity with potentially best-in-class profiles."

About Amylin and Dual Amylin/Calcitonin Agonists

Amylin has important effects on glucose management, glucagon production, gastric emptying time and satiety.  Amylin analogs have been shown to significantly reduce body weight and dosage of insulin.  Dual amylin and calcitonin receptor agonists are the most potent amylin receptor agonists.  Cagrilintide is a dual amylin/calcitonin receptor agonist that is currently in clinical development.

About Viking Therapeutics, Inc.

Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders, with three compounds currently in clinical trials. Viking's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives. Viking's clinical programs include VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders. The compound successfully achieved both the primary and secondary endpoints in a recently completed Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis. In a Phase 2a trial for the treatment of non-alcoholic fatty liver disease (NAFLD) and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content compared with patients who received placebo. Viking is also developing VK2735, a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors for the potential treatment of various metabolic disorders. Data from a Phase 1 and a Phase 2 trial evaluating VK2735 (dosed subcutaneously) for metabolic disorders demonstrated an encouraging safety and tolerability profile as well as positive signs of clinical benefit. The company is also evaluating an oral formulation of VK2735 in a Phase 1 trial. In the rare disease space, Viking is developing VK0214, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the potential treatment of X-linked adrenoleukodystrophy (X-ALD). VK0214 is currently being evaluated in a Phase 1b clinical trial in patients with the adrenomyeloneuropathy (AMN) form of X-ALD.

For more information about Viking Therapeutics, please visit www.vikingtherapeutics.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding Viking Therapeutics, Inc., under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its clinical and preclinical development programs, anticipated timing for reporting clinical data and cash resources.  Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance.  These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of Viking's product candidate development activities and clinical trials, including those for VK2735, VK0214, VK2809, the company's incretin receptor agonists, and its amylin and calcitonin receptor agonists; risks that prior clinical and preclinical results may not be replicated; risks regarding regulatory requirements; and other risks that are described in Viking's most recent periodic reports filed with the Securities and Exchange Commission, including Viking's Annual Report on Form 10-K for the year ended December 31, 2023, and subsequent Quarterly Reports on Form 10-Q, including the risk factors set forth in those filings.  These forward-looking statements speak only as of the date hereof.  Viking disclaims any obligation to update these forward-looking statements except as required by law.