Shanghai, China – [September 16th, 2024] – SIMR Biotech announces the enrollment of the first patient in its Phase 2 clinical trial of SR750, a novel oral treatment for trigeminal neuralgia (TN).
The Phase 2 clinical trial is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, and optimal dosing of SR750 in patients with TN. The study aims to explore the potential of SR750 to alleviate TN-associated pain and improve the quality of life for patients.
The initiation of this Phase 2 trial follows promising results from the Phase 1 studies in China and Australia, where SR750 demonstrated a favorable safety profile. The enrollment of the first patient in this Phase 2 trial marks an important milestone for SIMR Biotech, reflecting the company's commitment to advancing innovative treatments for chronic pain. SR750, with its novel mechanism of action and FDA Orphan Drug Designation, has the potential to become a breakthrough therapy for TN, providing a new option for patients where current treatments often fall short.
About SR750
SR750 is a first-in-class small molecule with a novel mechanism of action targeting neuropathic pain pathways. Developed by SIMR Biotech, SR750 offers a new approach to treating TN by targeting pain sensitization caused by trigeminal nerve root injury while avoiding central nervous system side effects, making it a potential new therapeutic option for this condition. Administered orally, SR750 has shown a strong safety and efficacy profile in preclinical studies and early-phase clinical trials. The drug has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA), recognizing its potential as a promising treatment for rare conditions like TN.
About Trigeminal Neuralgia
Trigeminal neuralgia (TN) is a rare, chronic neuropathic pain condition affecting the trigeminal nerve, which is responsible for facial sensation. It is characterized by sudden, severe, electric shock-like pain in the facial area, typically affecting one side and occurring in the distribution area of one or more branches of the trigeminal nerve. These episodes of intense pain begin and end abruptly and are often triggered by non-painful stimuli, such as touching the face, eating, or speaking. TN is a highly debilitating condition that severely impacts patients' quality of life. Current treatment options primarily include medication and surgical intervention, but the long-term failure rate of first-line drug treatments is high (approximately 50%), often accompanied by central nervous system side effects or skin allergies. This highlights the urgent need for new therapeutic approaches that can provide effective and safer treatment options.
