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Viking Therapeutics and PoC Capital Enter Agreement to Fund Clinical Development of VK2809 in Glycogen Storage Disease Ia (GSD Ia)

Tuesday, February 14, 2017 General News J E 4
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Company to File IND and Initiate Human Proof-of-Concept Study in 2017

SAN DIEGO, Feb. 14, 2017 /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 an agreement with PoC Capital, LLC to fund Viking's initial clinical development of VK2809 in glycogen storage disease type Ia (GSD Ia).  Viking plans to file an Investigational New Drug (IND) application for VK2809 for the treatment of GSD Ia and initiate a human proof-of-concept study in the second half of 2017. 

Under the terms of the agreement, PoC Capital will be responsible for paying up to $1.8 million in expenses associated with VK2809 clinical studies, including a planned proof-of-concept trial in patients with GSD Ia.  In exchange, up to $1.8 million in Viking shares will be issued to PoC Capital.

Viking's agreement with PoC Capital follows the company's recent announcement of positive top-line results from a proof-of-concept study of VK2809 in an in vivo model of GSD Ia.  Data from the study, conducted under a sponsored research agreement between Duke University and Viking, demonstrated that treatment with VK2809 led to statistically significant reductions in key metabolic markers of GSD Ia.  Mean liver triglyceride content was reduced by more than 60% in VK2809-treated animals relative to vehicle-treated control animals, while average liver weight was reduced by more than 30% vs. controls.  In addition, average liver weight as a percent of total body weight declined by approximately 20% in treated vs. control animals.  The ongoing study is continuing to evaluate the impact of VK2809 on these and other disease markers.  Detailed data will be submitted for presentation at an appropriate scientific conference.

GSD Ia is a rare, orphan genetic disease characterized by an inability to metabolize glucose precursors, resulting in hypoglycemia and increased lipogenesis.  The disease is caused by mutations in the gene for glucose-6-phosphatase (G6PC), a critical enzyme involved in the production of glucose from either glycogen or gluconeogenesis.  Impaired G6PC function leads to dramatically elevated liver triglyceride levels in human patients and in animal models of the disease.  In patients, this may contribute to serious long-term complications, such as severe hepatomegaly, hepatic adenomas, and hepatocellular carcinoma.  Manifestations of the disease begin to appear shortly after birth and continue through adolescence into adulthood.  There is currently no approved pharmacologic therapy for GSD Ia.

"We are pleased to enter into this agreement with PoC Capital as it will allow us to conduct the initial clinical work evaluating VK2809 in GSD Ia in a capital efficient manner.  We view GSD Ia as an attractive development opportunity for VK2809, where we can leverage prior human data showing the drug candidate's robust effect on plasma triglycerides, as well as our recent results demonstrating promising efficacy in an animal model of the disease," said Brian Lian, Ph.D., chief executive officer of Viking.  "GSD Ia is an indication with a high unmet medical need where we believe VK2809 could yield important benefits to patients who have otherwise limited therapeutic options.  As such, we are interested in evaluating the drug candidate's potential effects in a clinical proof-of-concept study."

"In collaboration with researchers from Duke University, the team at Viking has generated encouraging data in a model of GSD Ia, a rare genetic condition.  We are very pleased to support Viking's plan to run a proof-of-concept study with VK2809, a selective thyroid hormone receptor beta agonist," said Daron Evans, managing director of PoC Capital.  "Viking's strong research team has the potential to open the door to this and other potential orphan indications with their deep pipeline of therapeutic products."

VK2809 is a novel, orally available small molecule thyroid receptor beta (TR?) agonist that possesses selectivity for liver tissue, as well as the beta receptor subtype, suggesting promising therapeutic potential in a range of lipid disorders.  Viking is currently evaluating VK2809 in a randomized, double-blind, placebo-controlled, parallel group Phase 2 study designed to assess the drug candidate's efficacy, safety and tolerability in approximately 80 patients with elevated LDL-C and non-alcoholic fatty liver disease.  Previously reported clinical data have demonstrated that treatment with VK2809 leads to significant reductions in plasma triglycerides, LDL cholesterol (LDL-C), and atherogenic protein levels in subjects with mild hypercholesterolemia.

About GSD IaGlycogen storage disease Ia (GSD Ia) is a rare, orphan genetic disease caused by a deficiency of glucose-6-phosphatase (G6PC), an enzyme responsible for the liver's production of glucose from glycogen and gluconeogenesis.  The disease, for which there is no approved pharmacologic therapy, results in an excess accumulation of glycogen and lipids in the liver, potentially leading to hepatic steatosis, liver failure, development of hepatic adenomas, and hepatocellular carcinoma.  Increased triglyceride production and elevated triglyceride levels are characteristic of GSD Ia and associated with many manifestations of the disease.  GSD Ia is estimated to occur in approximately 1 in every 50,000 – 100,000 births in the United States.  As manifestations of the disease begin to present themselves at birth, a sizeable portion of GSD Ia patients are children.

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 metabolic and endocrine disorders.  The company's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives.  Viking has exclusive worldwide rights to a portfolio of five therapeutic programs in clinical trials or preclinical studies, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated.  The company's clinical programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator, or SARM, in Phase 2 development for the treatment and prevention of lean body mass loss in patients who have undergone hip fracture surgery, VK2809, a small molecule thyroid beta agonist in Phase 2 development for hypercholesterolemia and fatty liver disease, and VK0612, a first-in-class, orally available drug candidate in Phase 2 development for type 2 diabetes.  Viking also plans to initiate a proof-of-concept study of VK2809 in patients with glycogen storage disease type Ia.  The company is also developing novel and selective agonists of the thyroid beta receptor for adrenoleukodystrophy, as well as two earlier-stage programs targeting metabolic diseases and anemia.

Follow Viking on Twitter @Viking_VKTX.

About PoC CapitalPoC Capital, LLC (www.poccap.com) invests in life science companies whose therapeutics, devices or diagnostics have the opportunity to improve patient health and well-being. Strong management teams, clear mechanisms of action, and well-validated product development plans are key components of PoC's investment thesis. PoC Capital provides targeted funding for companies to execute proof-of-concept clinical trials that have the potential to unlock the value of development-stage assets through safety and efficacy validation.

Forward-Looking StatementsThis press release contains forward-looking statements regarding Viking Therapeutics, including statements about Viking's expectations regarding its development activities, timelines and milestones, as well as the company's goals and plans regarding VK2809 and VK2809's prospects. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially 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 VK2809; risks that prior clinical and pre-clinical results may not be replicated; and risks regarding regulatory requirements, among others. These forward-looking statements speak only as of the date hereof.  Viking disclaims any obligation to update these forward-looking statements.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/viking-therapeutics-and-poc-capital-enter-agreement-to-fund-clinical-development-of-vk2809-in-glycogen-storage-disease-ia-gsd-ia-300406828.html

SOURCE Viking Therapeutics, Inc.

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