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BIA-Brukerstyrt innovasjonsarena

Clinical development of TQ-217, a novel drug candidate for treatment-resistant epilepsy

Alternative title: Klinisk utprøvning av TQ-217, en ny medikamentkandidat for behandlingsresistent epilepsi

Awarded: NOK 10.2 mill.

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Project Period:

2023 - 2026

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Epilepsy is a common disease that affects one out of every hundred people. One third of all people with epilepsy do not respond to any of the approved epilepsy drugs, and still have epileptic seizures which can happen at any moment, and which can be life-threatening. These epilepsy patients are said to have "treatment-resistant" seizures. There are over 20 million treatment-resistant epilepsy patients worldwide. Although there are over 25 drugs that have been approved to treat epilepsy patients, most of these work through only 4 different mechanisms. In order to help treatment-resistant epilepsy patients, we therefore need to discover new drugs that work through different mechanisms. Theracule has discovered a new drug candidate for epilepsy, called TQ-217, which inhibits epileptic seizures through a mechanism that is different from all other epilepsy drugs. TQ-217 is a mix of turmerones, which are natural molecules isolated from turmeric essential oil. TQ-217 does not contain curcumin or other curcuminoids. The purpose of this project, called EPITHERA, is to test TQ-217 in the clinic to show that it is safe and can block seizures in treatment-resistant epilepsy patients. Working together with the University of Oslo and the Medical University of Lublin in Poland, Theracule will investigate how TQ-217 inhibits seizures in animal models. Working together with Oslo University Hospital, we will carry out a Phase 1 clinical trial with healthy human volunteers to test the safety of TQ-217 and to see how the drug is distributed in, and excreted from, the body. Finally, working together with Frankfurt University Hospital in Germany, we will carry out a Phase 2 clinical trial in treatment-resistant epilepsy patients, to test how well TQ-217 can block seizures in these patients, and to see how well it is tolerated when taken in combination with other epilepsy drugs.

THE PROBLEM: Epilepsy is the fourth most common neurological condition, affecting over 50 million people worldwide and over 6 million in Europe, and it is characterized by spontaneous, recurring seizures. Despite the approval of more than 25 anti-seizure medications (ASMs), many drugs share the same mechanism of action. Approximately 30% of epilepsy patients continue having seizures despite taking medication and are said to have "drug-refractory" or "treatment-resistant" epilepsy. THE SOLUTION: TQ-217 is Theracule's (B1's) drug candidate for treatment-resistant epilepsy. TQ-217 has a novel mechanism of action versus all other ASMs (potential for first-in-class), has efficacy in multiple animal models of drug-refractory epilepsy, and has low risk for drug-drug metabolic interactions – important for epilepsy patients taking drug combinations. TQ-217 is a botanically derived drug candidate consisting of pure turmerones, drug-like small molecules isolated from curcuma (turmeric). Theracule is the exclusive licensee of international patent WO 2013/004740 claiming the use of turmerones for the treatment of epilepsy. The safety of turmerone-containing preparations has been extensively evaluated in rats, dogs, and humans. THE GOAL of EPITHERA is to generate clinical proof-of-concept for TQ-217 as a novel first-in-class treatment for drug-refractory epilepsy. The project goals of EPITHERA include the preclinical evaluation of efficacy in animal models, and the clinical evaluation of safety in healthy volunteers, and of efficacy and safety in epilepsy patients. The proposed project outcome is a package with the clinical and nonclinical data and IP required for out-licensing to a pharma partner for further development and commercialization. EPITHERA will enable Theracule to acquire know-how to build up API manufacturing capacity in Norway post-project. TQ-217 is a botanical drug manufactured from food industry by-products, thereby contributing towards a Sustainable Economy.

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BIA-Brukerstyrt innovasjonsarena