Viking Therapeutics Inc., a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders, announced that it has obtained an exclusive worldwide license to five novel therapeutic programs from Ligand Pharmaceuticals Inc. The license includes programs targeting type 2 diabetes (Phase 2b) and cancer cachexia (Phase 2) that Viking is currently preparing to advance into mid-to-late stage clinical trials. Viking is solely responsible for all development activities under the license. Ligand has also agreed to invest $2.5 million in Viking to fund operating expenses.

 

The programs covered in the license agreement include Ligand’s FBPase inhibitor program for type 2 diabetes, a Selective Androgen Receptor Modulator (SARM) program for muscle wasting, a Thyroid Hormone Receptor-b (TRb) Agonist program for dyslipidemia, an Erythropoietin Receptor (EPOR) Agonist program for anemia, and an Enterocyte-Directed Diacylglycerol Acyltransferase-1 (DGAT-1) Inhibitor program for dyslipidemia.

 

“Along with our partners at Ligand, we have created through this license an excellent vehicle to develop several promising new therapies for patients, while unlocking potential value for stakeholders,” said Brian Lian, president and CEO of Viking Therapeutics. “Each of the licensed programs has what we believe to be first-in-class or best-in-class characteristics and a differentiated therapeutic profile. Importantly, the portfolio fits well within Viking’s focus, as our team has an extensive history in diabetes and endocrine drug development, including two recent drug approvals. At all levels, from preclinical through pharmaceutical development, and including our chief medical officer, we have well-aligned development expertise to bring these programs forward.”

 

“Ligand has been exploring opportunities to increase the investment in certain of our research programs in order to advance them to major inflection points. This is a creative transaction that establishes a bold portfolio of early- and mid-stage assets that have the potential to generate substantial news flow over the next 12 to 24 months and to be the basis for important new drugs in major therapeutic categories,” said John Higgins, president and CEO of Ligand Pharmaceuticals. “A relationship such as this one with Viking gives Ligand the opportunity to entrust valuable internal programs to a dedicated team with the operational resources to take them to the next level.” 

 

Drug candidates and programs covered by the license agreement include:

• VK0612, a potent, selective inhibitor of fructose-1,6-bisphosphatase, or FBPase, an enzyme that plays an important role in endogenous glucose production, or the synthesis of glucose by the body. Clinical trials to date have shown that VK0612 is safe, well-tolerated and leads to clinically significant glucose-lowering effects in patients with type 2 diabetes. Viking intends to commence a Phase 2b clinical trial of VK0612 in patients with poorly-controlled type 2 diabetes.
• VK5211, a novel, orally available, non-steroidal SARM in development for the treatment of cancer cachexia. VK5211 is designed to produce the therapeutic benefits of testosterone with improved safety, tolerability and patient acceptance due to a tissue-selective mechanism of action and an oral route of administration. Viking plans to commence a Phase 2 proof of concept clinical trial in patients with cancer cachexia.
• VK0214, a novel, orally available, liver-selective TRβ agonist for lipid disorders such as dyslipidemia and NASH. The unique liver-targeting properties of TRβ agonists are designed to reduce or eliminate the deleterious effects of extra-hepatic thyroid receptor activation. Viking plans to complete the toxicity, pharmacology and chemistry, manufacturing and controls studies needed for an IND filing for VK0214.
• A portfolio of orally available small molecule EPOR agonists for the potential treatment of anemia. These drug candidates have the potential to treat anemia with improved safety, tolerability and route of administration compared with currently available therapies. Viking plans to conduct further preclinical studies in support of a potential IND filing.
• A portfolio of orally available small molecule inhibitors of the enzyme DGAT-1 for the potential treatment of lipid disorders such as obesity and dyslipidemia. Viking plans to conduct further preclinical studies in support of a potential IND filing.

 

“Our development strategy will focus on achieving important clinical milestones with the FBPase, SARM, and TRb programs, while working to establish non-clinical proof-of-concept with the EPOR and DGAT-1 programs,” said Lian. “We share Ligand’s belief that medically important new therapies such as these should be advanced to key value-creating milestones.”

 

Date: May 22, 2014

Source: Viking Therapeutics