Addex Therapeutics, a leader in allosteric modulation-based drug discovery and development, has announced that an Independent Interim Review Committee (IRC) has recommended the continuation of their ADX71149 (JNJ-40411813) Phase 2 epilepsy clinical study.
The study is sponsored by Janssen Pharmaceuticals, Inc. and has been based on unblinded data from the first cohort of patients. This is a major milestone for Addex and a step forward in their mission to improve treatment options for those living with epilepsy.
The news of the IRC’s recommendation and our collaboration partner’s decision to continue the ADX71149 clinical study is extremely encouraging. It implies that the drug may be safe and well tolerated, and could have a positive impact on the patient population. We are thrilled to provide further updates on the progress of this important study in the latter part of 2021.
ADX71149 is a groundbreaking selective metabotropic glutamate sub-type 2 (mGlu2) receptor positive allosteric modulator (PAM) currently undergoing a multi-center Phase 2 study. This study is assessing the efficacy, safety, tolerability, and pharmacokinetics of ADX71149 when administered as an adjunctive treatment to levetiracetam or brivaracetam in patients suffering from focal onset seizures.
Up to 3 doses of ADX71149 will be tested out in up to 160 patients, with the primary objective being to evaluate the efficacy of ADX71149 in combination with levetiracetam or brivaracetam. The study is divided into two parts; Part 1 evaluates the acute efficacy of ADX71149 over 4 weeks, while Part 2 is the maintenance efficacy phase and runs for 8 weeks.
With Cohort 1 already completing Part 1 and Cohort 2 recruiting patients for Part 1, ADX71149 is proving to be a promising drug with the added benefit of an open-label extension part of the study for those who complete Part 1 and/or Part 2. This open-label extension will evaluate the long-term efficacy and safety of ADX71149 for up to 2 years.
Glutamate mGlu2 Receptors and Epilepsy
Glutamate plays an integral role in the brain, acting as an excitatory neurotransmitter to initiate and spread seizures. Positive allosteric modulation of mGlu2 receptors, such as ADX71149, has emerged as a promising novel approach in epilepsy treatment.
In animal models, it has been demonstrated to normalize excessive glutamate release, offering an improved tolerability and safety compared to current treatments. As a result, the development of ADX71149 and other mGlu2 PAMs have been highly anticipated, with proof of concept data recently published in Epilepsia.
About Our Collaboration
Addex has entered into a research collaboration and license agreement with Janssen Pharmaceuticals, Inc. that grants the company an exclusive worldwide license to develop and commercialize mGlu2 PAM compounds, such as ADX71149.
If successful, Addex stands to gain up to €109 million in success-based development and regulatory milestone payments, as well as low double-digit royalties on any net sales. This promising agreement has the potential to be incredibly lucrative for Addex.
About Addex Therapeutics
Addex Therapeutics is a clinical-stage pharmaceutical company on a mission to develop and commercialize a new class of powerful, orally-available, small molecule drugs known as allosteric modulators to treat neurological disorders.
Allosteric modulators offer the potential to improve upon conventional treatments, and Addex is focusing on receptors and proteins essential for therapeutic intervention. Its lead drug candidate, ADX71149, is currently in Phase 2 clinical trials for epilepsy, and dipraglurant is being evaluated for future development for a range of indications.
Addex also has a broad preclinical pipeline, which includes the development of GABAB PAMs for CMT1A, chronic cough and various types of pain, mGlu7 NAMs for stress-related disorders, mGlu2 NAMs for mild neurocognitive disorders and depression, M4 PAMs for schizophrenia and other forms of psychosis, as well as mGlu4 PAMs and mGlu3 PAMs.
Addex’s shares are listed on SIX Swiss Exchange and American Depositary Shares represent its shares on the NASDAQ Capital Market, trading under the ticker symbol “ADXN”.