Restoring Hope: WinSanTor's Innovative Approach to Peripheral Neuropathy

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John, a trial patient who participated in WinSanTor's experimental treatment for peripheral neuropathy
WinSanTor

Imagine waking up every day with your legs tingling and numb, like they've fallen asleep, but with a throbbing pain. Walking feels like trudging through quicksand drunk. You realize sleeping won't let you escape this living nightmare. This daily battle affects everything, turning simple joys like playing with your kids or taking a walk into sources of anxiety and frustration. For many, it leads to severe complications, even amputations, blindness, and more. The suffering, anxiety, and hopelessness drive many to thoughts of suicide. This is the daily hell for patients with peripheral neuropathy.

According to Neuropathy Commons, peripheral neuropathy is a neurodegenerative condition that robs the quality of life of over 40 million Americans and over 8% of the global population. It affects more people than all other neurodegenerative diseases combined, including dementia, Alzheimer's, Parkinson's, ALS, MS, and others, yet it receives far less attention and funding than any one of these other diseases individually.

A significant reason for this is that peripheral neuropathy is a complication (some over 50%) of many other diseases and injuries, including diabetes, chemotherapy/cancer, infections, or toxic substances. It's also common with aging, where nerve damage is prevalent but often goes unrecognized until symptoms worsen. It is underdiagnosed, underappreciated, and often goes untreated due to a lack of awareness of the disease, peripheral neuropathy, independent of the underlying cause.

Current treatments focus on mitigating the underlying cause, like reducing chemotherapy doses or using drugs like gabapentin and opioids for pain relief, which at best mask sensation for a fraction affected by pain. However, these fail to address the nerve damage, leaving sufferers with chronic, irreversible pain, numbness, and weakness.

"This is where science is changing things," says Stanley Kim, CEO and co-founder of WinSanTor. "We are starting to understand peripheral neuropathy, particularly as its own disease."

Peripheral neuropathy means peripheral nerve damage, and although there are many causes, the biology for many types of peripheral neuropathies is the same. Mitochondria are tiny structures within each cell responsible for producing cellular energy, also known as ATP (adenosine triphosphate). Nerve cells require substantial ATP for signaling, maintenance, and repair. Damage to mitochondria diminishes ATP supply to nerves, resulting in dysfunction, damage, and neuropathy symptoms. Healthy mitochondria are crucial for preventing and managing peripheral neuropathy by ensuring nerve repair and proper function.

WinSanTor is a private biotechnology company revolutionizing the fight against peripheral neuropathy. Its origin starts as a coalition of leading researchers gathered and funded by JDRF and the US and Canadian governments to solve this significant unaddressed need. "We were fortunate to have received significant peer-reviewed grants to focus on the science," says Kim, whose previous companies were acquired by Qualcomm and Apple. "Our approach, strategy, and motivation, and fortunately our funding, was purely based on continuing if we saw positive results to maximize patient impact."

WinSanTor's scientific founders, Paul Fernyhough and Nigel Calcutt, discovered that pirenzepine targets nerve repair and growth, potentially reversing peripheral neuropathy. This drug boosts cellular energy, aiding nerve regeneration. CEO Stanley Kim explains, "We developed a platform technology, and for our first endeavor, we repurposed pirenzepine, a drug with a well-documented safety profile for stomach ulcers, into a topical formulation, WST-057, to repair peripheral nerves where the damage begins, the extremities."

WinSanTor's recently completed Phase 2 studies showed significant nerve regeneration and symptom improvement—the first to potentially reverse this neglected disease. In a risk-averse industry such as biotech, WinSanTor is doing things new and different. "Everything is new, and we are redefining the disease," says Kim. The European Medicines Agency has given the green light for Phase III trials, moving WinSanTor closer to regulatory approval and widespread accessibility in the next few years. In parallel, WinSanTor is racing for global expedited approval through Early Access Programs, which allows conditional sales in certain countries. While pirenzepine awaits longer U.S. approval, WinSanTor will launch an Expanded Access Program (EAP) (aka Compassionate Use) to meet urgent patient needs under FDA guidelines. They've already partnered with Japan's top medical derm company and are in talks with others.

With commercial opportunities abound, WinSanTor is ready to come out of stealth. WinSanTor offers hope for millions suffering silently. By targeting a root cause of nerve damage, they are pioneering treatments that could change lives. "By raising awareness about its prevalence and symptoms, we hope to prompt more research, better diagnosis, and ultimately, effective treatment," Kim asserts. "There is a lot to do, but we know the rewards will be amazing for everyone."

Join WinSanTor's mission today and make a tangible difference in the lives of millions impacted by peripheral neuropathies.

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