Metabolic and endocrine disorders-focused Viking Therapeutics (NASDAQ:VKTX) has been encouraged by results from a pre-clinical study of its lead program for muscle and bone disorders.
The company presented new data from a pre-clinical study examining the physiologic impact of its VK5211 treatment in primates following 13 weeks of treatment at the eighth International Conference on Cachexia, Sarcopenia and Muscle Wasting, held last week in Paris..
The study findings showed “robust weight gains” in all VK5211 treatment groups as compared to both baseline and controls, Viking said.
“Importantly, treated cohorts demonstrated progressive weight gain throughout the course of treatment and retained a substantial portion of the increased weight post-treatment,” the company noted.
The safety of VK5211 was also evaluated in this study. No ophthalmic, electro-cardiographic or heart rate changes were observed with VK5211 dosing. In addition, no significant changes to clinical chemistry or haematologic factors were observed.
Minimal to moderate alterations in clinical pathology parameters that were consistent with potent stimulation of the androgen receptor were observed in VK5211-treated cohorts. These findings are not anticipated to result in safety concerns in an elderly human population, Viking assured.
VK5211 is the company's lead program, and is a treatment for muscle and bone disorders. It is an orally available, non-steroidal selective androgen receptor modulator (SARM) designed to selectively stimulate muscle and bone formation with reduced activity in peripheral tissues such as skin and prostate.
The company believes these characteristics may provide important benefits to patients recovering from hip fracture and is currently operating a Phase 2 clinical trial of VK5211 in up to 120 patients who recently suffered a hip fracture.
"These results build upon the impressive anabolic responses observed in prior studies of VK5211. The significant increases in weight observed in this study, which continued through the entire 13 week treatment window, are quite promising and consistent with data from a previous human Phase 1 study, which demonstrated increases in muscle mass after only three weeks of exposure," said Brian Lian, Ph.D., chief executive officer of Viking.
"We believe such effects, if replicated in further human studies, could provide benefits in settings where patients experience abnormal losses of muscle.
“We recently announced the initiation of a 12 week Phase 2 trial of VK5211 in patients recovering from hip fracture, a large population known to experience prolonged disability and increased risks of re-fracture due to muscle and bone loss. Today's results provide additional reasons to be enthusiastic about the potential benefits of VK5211 on muscle growth and we are excited to continue our aggressive development plan for this important therapy,” Dr Lian added.