Approximately 800,000 diabetics in the U.S. are treated annually for symptoms of Peripheral Neuropathy

Diabetic peripheral neuropathy (DPN) and the associated microvascular (small blood vessel) damage can lead to foot ulcers and amputations. DPN is the leading cause of non-traumatic lower-limb amputations among people with diabetes in the United States, accounting for more than 80,000 amputations each year.

Peripheral neuropathy is a dying back of nerve fibers, particularly in the extremities of the feet, legs and hands. In this disease the protective sheath, or myelin, that protects the nerve, degenerates, resulting in nerve exposure and subsequent nerve damage. Sensory symptoms of DPN include numbness, prickling, aching pain, burning pain, stabbing pain, and allodynia (a condition in which ordinarily non-painful stimuli evoke pain, such as a bed sheet touching a leg).

Neuropathy can also lead to problems with internal organs. Neuropathy increases with age, how long you have diabetes, and worsening of glucose tolerance. Tight blood glucose control is the only way to stop the disease at present, but even that doesn’t always work.

In animal models of diabetic neuropathy, the active component of FGF-1141, human FGF-1 has shown efficacy in stimulating the growth and repair of leg nerves, leading to increased motor and sensory function in the animal’s leg. CVBT will confirm these results in additional animal studies before planning a clinical development program.

About 17 million individuals in the United States have been diagnosed with diabetes, and it is estimated that between 60% to 70% have some degree of DPN. Treatment costs related to DPN, incurred by all payers, total nearly $11 billion.

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