Hepatocyte growth factor for walking performance in peripheral artery disease

Area of Science:

• Regenerative Medicine
• Vascular Biology
• Gene Therapy

Background:

• VM202 encodes two hepatocyte growth factor isoforms, which promote angiogenesis and muscle regeneration in preclinical models.
• Peripheral artery disease (PAD) causes symptomatic lower extremity ischemia, impairing walking ability.

Purpose of the Study:

• To evaluate the efficacy of VM202 gastrocnemius muscle injections for improving walking performance in patients with symptomatic PAD.
• To assess the impact of VM202 on skeletal muscle characteristics and perfusion.

Main Methods:

• A double-blind, placebo-controlled trial randomized PAD patients to receive VM202 or placebo injections every 14 days for four treatments.
• The primary endpoint was the change in 6-minute walk distance at 6 months. Secondary endpoints included treadmill walking time and muscle biopsy findings.

Main Results:

• VM202 did not significantly improve the 6-minute walk distance at 6 months compared to placebo.
• However, VM202 treatment led to a significant improvement in treadmill walking time at 3 months and increased central nuclei in muscle biopsies.
• Post hoc analysis indicated a potential benefit of VM202 in PAD patients with diabetes mellitus for the 6-minute walk distance.

Conclusions:

• Gastrocnemius injections of VM202 did not demonstrate efficacy in improving the 6-minute walk distance for PAD patients.
• Secondary outcomes suggest a potential benefit of VM202 on skeletal muscle and treadmill performance, especially in PAD patients with diabetes.