FDA clears clinical trials for Lynk’s oral MS therapy
LNK01006 designed to cross blood-brain barrier
- FDA cleared clinical trials for LNK01006, an oral therapy for multiple sclerosis.
- LNK01006 inhibits the TYK2 enzyme, reducing inflammation in the central nervous system.
- The therapy is designed to cross the blood-brain barrier, targeting neuroinflammatory diseases.
Lynk Pharmaceuticals has received the green light from the U.S. Food and Drug Administration (FDA) to begin clinical trials of its investigational oral therapy LNK01006, which is being developed for multiple sclerosis (MS) and other neuroinflammatory diseases.
“We look forward to advancing this promising molecule into human clinical trials and bringing new therapeutic options to treat patients suffering from neurodegenerative diseases,” Michael Lawrence Vazquez, PhD, co-founder and executive vice president of Lynk, said in a company press release.
The company did not disclose details about the planned trials.
MS is caused by inflammatory attacks that damage nerve cells in the central nervous system (CNS), the brain and spinal cord. The molecular mechanisms driving inflammation in MS are complex and not fully understood.
LNK01006 is an inhibitor of the TYK2 enzyme, which plays an important role in promoting the growth of specific types of immune T-cells that are involved in inflammatory diseases that affect the CNS, including MS. By inhibiting TYK2, the therapy is expected to reduce the activation of pro-inflammatory T-cells, easing inflammation in the CNS. Because genetic studies have suggested that people with lower TYK2 activity are less likely to develop MS, this enzyme has been investigated as a therapeutic target in MS.
Crossing the blood-brain barrier
LNK01006 is an allosteric inhibitor, meaning it reduces TYK2 activity by altering its shape. Unlike other TYK2 inhibitors, the orally available small molecule targets a region of the enzyme called the JH2 domain, which is expected to cause fewer side effects while reducing inflammation.
LNK01006 is designed to cross the blood-brain barrier, a membrane that protects the brain and spinal cord from potential threats, and enter the CNS.
“Our CNS penetrant TYK2 inhibitor was specifically designed to cross the BBB (blood brain barrier) and afford high CNS exposure,” Vazquez said. “We leveraged medicinal chemistry principles and molecular design to optimize the physical properties, potency and selectivity.”
In preclinical studies, LNK01006 demonstrated high brain penetration and promising efficacy in preventing MS in animal models of the disease, according to the company.
“LNK01006 is a novel brain-penetrant allosteric TYK2 inhibitor designed to modulate CNS-relevant inflammatory pathways,” said Jun Wang, PhD, co-founder and chief scientific officer of Lynk. “Supported by strong evidence from human genetics and patient gene-expression studies and by robust efficacy in preclinical neuroinflammation models, LNK01006 represents a promising new therapeutic approach for CNS diseases with significant unmet need.”
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