Study with JNJ-40411813 (ADX71149) will treat first epilepsy patients in early 2021
Geneva, Switzerland, June 16, 2020 – Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, today announced that the selective metabotropic glutamate type 2 (mGlu2) receptor positive allosteric modulator (PAM), JNJ-40411813 (ADX71149), will advance into a Phase 2a proof of concept study in patients with epilepsy. The multi-center study is scheduled to begin dosing patients in the United States early 2021. Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, is responsible for the clinical development and commercialization of JNJ-40411813 (ADX71149) under the terms of a licensing agreement with Addex.
Glutamate 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.
“The decision of Janssen to advance ADX71149 into a Phase 2 clinical study is an exciting development and an important achievement for us,” said Tim Dyer, CEO of Addex. “Addex now has two active clinical programs with a number of significant value creating milestones ahead, two major collaborations with pharma and a pipeline of earlier-stage programs that are moving rapidly towards the clinic.”
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) using a time-to-event endpoint.
“Preclinical studies in epilepsy models have demonstrated a strong synergistic anti-epileptic effect of ADX71149 and levetiracetam when given in combination,” said Robert Lütjens, Head of Discovery Biology of Addex. “We are now looking forward to testing this hypothesis in the clinic, as this represents a completely novel approach based on a rational polypharmacy concept.”