Vertex Pharmaceuticals reported positive Phase 2 study results for a pain drug to treat diabetic peripheral neuropathy (DPN) early Wednesday. Vertex stock broke out during a 13% rally Wednesday.
DPN is a long-term complication from diabetes that results in damage to peripheral nerves, such as those in arms, legs and other extremities, due to exposure to high blood glucose levels, according to the Mayo Clinic. DPN can cause mild to debilitating pain, numbness, tingling and, in more severe cases, issues with digestion, bladder and heart rate control. If left untreated, DPN can increase the risk of ulcers, infections, bone and joint damage which could require amputation of the affected area.
Vertex's study of its NaV1.8 inhibitor VX-548 treatment resulted in a "statistically significant and clinically meaningful" reduction in patients' reported pain levels across all doses. During the study, Vertex had patients record daily pain intensity on a Numeric Pain Rating Scale (NPRS) to examine a change in the baseline for their weekly average.
The Surprising $5 Billion Opportunity That Drove Vertex Pharmaceuticals Stock To A Record High
More than 30% of patients achieved a 50% or greater reduction in pain across all dose groups compared to the baseline. More than 20% of patients in the mid- and high-dose groups reported a 70% or greater reduction in weekly average pain on the NPRS.
The company found VX-548 was well-tolerated during the 12-week study with no serious adverse events. Most adverse events (AEs) were mild to moderate. There was one death in the mid-dose group due to atherosclerotic cardiovascular disease, which was unrelated to the study, Vertex says.
Development Plan
The company plans to advance development of VX-548 following discussions with regulators. Vertex initiated a Phase 2 study of VX-548 for patients with painful lumbosacral radiculopathy (LSR). LSR is caused by injury or impairment to nerve roots near the lumbar spine.
Meanwhile, Phase 3 studies for VX-548 to treat acute pain are on track to read out in Q1 2024. Vertex hopes VX-548 will advance to become an alternative treatment to prescribing opioids.
The biotech firm will advance preclinical and clinical development of additional NaV1.8 and NaV1.7 inhibitors for both individual and combined use to treat acute and neuropathic pain.
Vertex Stock
Vertex stock leapt 13.2% Wednesday to break out on the news. VRTX reclaimed its 50-day moving average on the gain and decisively cleared a downtrend, passing a buy point for aggressive investors at 367.
Vertex stock is trading near the top of a buy zone for a flat base with a 387.42 entry.
VRTX rallied 40.3% so far this year through Wednesday's close.
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