ADX71149 for schizophrenia
Schizophrenia is a chronic progressive highly disabling and distressing disease. Patients suffer from a serious disorder affecting the ways they perceive the world around them that profoundly decreases their ability to function normally. Specifically, schizophrenia patients have difficulty separating real from imaginary experiences, suffer from inappropriate emotions and behaviors and have cognitive impairment. As a result, schizophrenia patients often withdraw from society and are unable to support themselves.
The prevalence of schizophrenia is estimated at about 1% of the population worldwide. Estimates of the costs to society from schizophrenia run at approximately $65 billion per year in the United States, despite the use of antipsychotic drugs. Indeed, notwithstanding their over $15 billion in annual sales, none of the currently marketed antipsychotic drugs adequately address the negative symptoms of schizophrenia, such as anxiety, depression and cognitive dysfunction. In addition, marketed antipsychotic drugs are known to cause side effects, including sedation, extrapyramidal symptoms (impairment of control of movements), hormonal imbalances leading to hyperprolactinemia and weight gain.
In 2011, our partner Janssen Pharmaceuticals Inc. initiated a 105-patient Phase IIa study of ADX71149 for the treatment of schizophrenia. The molecule was discovered and developed in collaboration with Janssen. ADX71149 is a metabotropic glutamate receptor 2 (mGluR2) positive allosteric modulator (PAM) that has the potential to be the first oral non-dopaminergic drug that may address both the positive and negative symptoms of schizophrenia, in addition to other indications, such as anxiety. ADX71149 is differentiated from marketed antipsychotics in that it may also show efficacy on negative symptoms and avoid compliance-limiting side effects like weight gain, hyperprolactinemia and extrapyramidal symptoms, which are associated with the use of dopamine antagonists.
Under the terms of this partnership, Janssen is responsible for all the costs of advancing this program through commercialization. We are eligible to receive development milestones totaling up to €112 million and low double-digit royalties on product sales.