Benzinga | Jan 21, 2021 05:28AM EST

Addex Therapeutics Announced its ADX71149 Received FDA IND Approval to Start a Phase 2a Clinical Study in Epilepsy; Shares Trading Up 120% in Premarket

Addex Therapeutics (NASDAQ:ADXN) today announced that its partner Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, has received FDA's Investigational New Drug (IND) approval to begin a Phase 2a proof of concept study with the selective metabotropic glutamate type 2(mGlu2) receptor positive allosteric modulator (PAM), JNJ-40411813 (ADX71149), in patients with epilepsy. The first patient is expected to be treated during Q2 2021.

"IND approval for the mGlu2 epilepsy study is great news to start 2021 and will be the first of three clinical studies we expect to be initiate this year," said Tim Dyer, CEO of Addex. "There is a great opportunity for an allosteric modulation approach in this difficult disease. We'd like to thank the team involved for their continued support and moving quickly to get this clinical study ready for patient enrolment."

The multi-center study will assess the efficacy, safety, tolerability and pharmacokinetics of adjunctive JNJ-40411813 (ADX71149) administration in patients with focal onset seizures with suboptimal response to levetiracetam. The primary objective of the study is to evaluate the efficacy of JNJ-40411813 (ADX71149) in combination with levetiracetam using a time-to-event endpoint.

"There is a strong preclinical rationale for mGlu2 PAM in epilepsy, including a true synergistic effect with levetiracetam," said Robert Ltjens, Head of Discovery Biology of Addex. "A highly synergistic anti-epileptic effect was observed when the two drugs were administered together, and we look forward to seeing this effect in epilepsy patients."

Glutamate, mGlu2 Receptors and EpilepsyGlutamate is the primary excitatory neurotransmitter in the brain and plays a key role in the initiation and spread of seizures. When activated, the mGlu2 receptor decreases the release of glutamate and consequently helps to maintain neurotransmitter balance. In the presence of agonist-induced activation, positive allosteric modulation of mGlu2 receptors could result in the normalization of the excessive glutamate release seen during a seizure. There is still an urgent need for more effective treatments for epilepsy, with improved tolerability and safety. JNJ-40411813 (ADX71149) was described in the Eilat 15 conference summary review as one of the most promising novel approaches currently in development (Bialer et al., 2019. Epilepsia). Proof of concept data with JNJ-40411813 (ADX71149) and other mGlu2 PAMs in animal models of epilepsy ha