Imagine a daily routine filled with simple joys—morning walks or bike rides—suddenly interrupted by a tingling in your feet. Over time, that sensation intensifies into persistent numbness and pain, making even the simplest tasks difficult. Eventually, like millions around the world, you're diagnosed with peripheral neuropathy—a condition that often leaves patients without effective treatment options.
Peripheral neuropathy affects over 30 million people in the United States and over 300 million globally. It manifests as tingling, numbness, severe pain, and muscle weakness, impairing quality of life and, in extreme cases, leading to complications such as amputations. Despite its prevalence, it remains underfunded and underdiagnosed, leaving many without hope. But now, WinSanTor, a pioneering biotechnology company, is changing that with cutting-edge science.
Unraveling the Complexities of Peripheral Neuropathy
Peripheral neuropathy is notoriously difficult to diagnose and treat because of its multifaceted nature. It can result from a variety of causes, such as diabetes, chemotherapy, infections, and even aging. By the time symptoms become severe, the underlying nerve damage is often extensive. Current treatments primarily focus on alleviating pain or treating underlying causes, with little emphasis on reversing the nerve damage itself.
At the heart of peripheral neuropathy lies mitochondrial dysfunction, which disrupts nerve function. The peripheral nervous system (PNS) is responsible for transmitting signals between the central nervous system (CNS) and the body. The axons of peripheral nerves, responsible for this transmission, grow and repair at a rapid rate—1–2 millimeters per day—requiring substantial energy in the form of ATP produced by mitochondria. When mitochondria become dysfunctional, as is common in neuropathy, neurons suffer energy deficits, oxidative stress, and inflammation, which in turn lead to nerve degeneration. This mitochondrial dysfunction plays a key role in neuropathy, and addressing it is critical to halting and reversing nerve damage.
The Groundbreaking Science of WinSanTor
WinSanTor's innovation centers on addressing this mitochondrial dysfunction through the use of antimuscarinic agents. The company's scientific founders, Drs. Paul Fernyhough and Nigel Calcutt are leaders in neuropathy research. Their work focuses on how muscarinic acetylcholine receptors (mAChRs) in peripheral nerves can be blocked using specific drugs to protect from nerve damage and actually reverse ongoing nerve fiber degeneration. These receptors regulate crucial processes such as neuronal excitability and calcium homeostasis. The blockade of these receptors using specific drugs triggers an endogenous repair pathway that prevents nerve damage and regenerates the peripheral nervous system.
Fernyhough and Calcutt demonstrated that by blocking mAChRs with antimuscarinic drugs, such as pirenzepine, it is possible to preserve mitochondrial function and protect nerve fibers from degeneration. Their research showed that pirenzepine not only halted nerve degeneration but actively promoted nerve regeneration by protecting the energy production within nerve cells.
"Muscarinic acetylcholine receptors regulate various mechanisms critical to nerve function, and by modulating these receptors, we're able to protect the mitochondria and prevent the cascade of cellular damage that leads to peripheral neuropathy," explains Dr. Fernyhough.
In laboratory models, they discovered that pirenzepine can also activate critical survival pathways, including AMPK-activated protein kinase (AMPK) and extracellular signal-regulated kinase (ERK), which are involved in cellular protection and repair. This pioneering research revealed the potential of antimuscarinic agents not only to protect neurons but also to stimulate their regeneration—offering hope for reversing the effects of neuropathy.
Repurposing Pirenzepine: A Surprising Solution
WinSanTor took this scientific breakthrough and applied it in an innovative way—repurposing pirenzepine, a drug originally developed to treat stomach ulcers, into a topical formulation for peripheral neuropathy. Known as WST-057, this topical gel is designed to deliver the drug directly to the nerves affected in the hands and feet, where the disease manifests most acutely.
"The disease begins with nerve damage in the extremities—so applying the drug topically allows us to target the root cause directly," explains WinSanTor CEO Stanley Kim. "No one had previously considered pirenzepine as a nerve-regenerating agent, but our research showed that it could address the condition at its source."
In recent Phase 2 clinical trials, WST-057 demonstrated significant nerve repair and symptom improvement. Notably, the treatment showed the potential to reverse nerve damage, not just alleviate symptoms. The ability to regenerate nerves in conditions like DPN and CIPN has never been seen before with existing treatments, making this approach a potential game changer for millions suffering from peripheral neuropathy.
Leading Scientists and Leadership Driving Innovation
Behind WinSanTor's scientific innovation is an exceptional team of experts. Drs. Paul Fernyhough and Nigel Calcutt have devoted decades to understanding the mechanisms of nerve degeneration, and their contributions to the field are widely recognized. Their groundbreaking research on antimuscarinics has opened new avenues for treating neuropathy and other neurodegenerative conditions.
Leading WinSanTor's business strategy is CEO Stanley Kim, who brings an impressive background in biotechnology and intellectual property. Kim co-founded SoftMax and Emotient, tech companies acquired by Qualcomm and Apple, and previously served as the Head of Intellectual Property at The Salk Institute, where he worked with iconic scientists. His expertise in guiding complex innovations to market has been instrumental in advancing WinSanTor's clinical trials and regulatory approvals.
Overcoming Regulatory Challenges and Expanding Access
Like any cutting-edge drug development, navigating the regulatory landscape has been one of the biggest hurdles for WinSanTor. However, the company has successfully gained approval from the European Medicines Agency to move into Phase 3 trials and is pursuing expedited approvals worldwide. Additionally, WinSanTor has initiated an Expanded Access Program (EAP) to meet the immediate needs of patients who cannot wait for the full approval process to play out.
"We understand the urgency for patients," says Kim. "That's why we are doing everything possible to fast-track this treatment to those who need it most."
A New Frontier in Treating Peripheral Neuropathy
The innovative approach developed by WinSanTor, underpinned by rigorous scientific research, offers the first real hope of reversing peripheral neuropathy. Their work is not just about managing symptoms—it's about addressing the underlying causes of nerve damage and providing long-term solutions for millions of people worldwide.
With a powerful combination of cutting-edge science and visionary leadership, WinSanTor is poised to transform the landscape of neuropathy treatment. "We have the leading scientists in the field, and we're committed to changing the lives of people who suffer from this debilitating condition," says Kim.
As the company moves into the next phase of its clinical trials, the future looks bright for patients awaiting real solutions. WinSanTor's innovations have the potential to redefine how peripheral neuropathy is treated, bringing hope to millions who have long been left with no viable options.
By focusing on the science behind nerve regeneration and mitochondrial protection, WinSanTor is paving the way for a new era in neurological treatments. Join them on their journey as they work to bring this revolutionary treatment to those who need it most.
