The registration program comprises two placebo-controlled studies. The first, Study 301, is a double-blind, placebo-controlled, parallel group design Phase 2b/3 pivotal clinical trial of dipraglurant (100 mg tid) in 140 PD-LID patients at approximately 50 sites in the
“The start of this pivotal study with dipraglurant is a significant milestone in Addex’s history and we are looking forward to evaluating this novel therapeutic in patients that urgently need more treatment options,” said
In a Phase 2a study dipraglurant met its primary endpoint by being generally well tolerated and showing no clinically significant safety issues. In addition, at Day 1 and Day 14, dipraglurant showed statistically significant effects on PD-LID clinical symptoms, as measured using the modified abnormal involuntary movement scale, or mAIMs. However, statistical significance was not achieved at Day 28 due in part to an increasing placebo response. The registrational 301 study has an improved design incorporating multiple methods for mitigating placebo response.
Levodopa is a mainstay therapy for the signs and symptoms of Parkinson´s disease, but as the disease
progresses, dyskinesia (abnormal involuntary movements) emerges in the majority of patients. Studies published in the
PD-LID is characterized by involuntary movements that may affect any body area, including the face, trunk or limbs. Oral levodopa is currently the most effective treatment available for the motor symptoms associated with Parkinson's disease. However, the development of dyskinesia which may be associated with long-term use of levodopa can become as disabling as the symptoms of Parkinson's disease. Dyskinesias are comprised principally of two types of movement: chorea, which is a rapid uncontrolled movement, and dystonia, which is a slow, often painful, writhing movement. The occurrence of PD-LID is linked to the neurodegenerative process of PD and is not solely related to the duration of dopamine replacement therapy. Physicians may try to reduce the dopaminergic therapy to try to lessen the impact of the dyskinesia but this is frequently at a cost of worsening the underlying motor symptoms of PD. Drug treatment for dyskinesia consists of off-label use of amantadine, and GOCOVRI (an extended release formulation of amantadine). Although amantadine-based treatments have shown efficacy, their use may be limited by side effects that are particularly problematic for PD patients. Therefore there is a clear need for improved therapies that offer effective symptom control with better tolerability.
About Addex Therapeutics
Addex Therapeutics is a clinical-stage pharmaceutical company focused on the development and commercialization of an emerging class of novel orally available small molecule drugs known as allosteric modulators for neurological disorders. Allosteric modulators offer several potential advantages over conventional non-allosteric molecules and may offer an improved therapeutic approach to conventional "orthosteric" small molecule or biological drugs. Addex’s allosteric modulator drug discovery platform targets receptors and other proteins that are recognized as essential for therapeutic intervention. Addex’s lead product candidate, dipraglurant (mGlu5 negative allosteric modulator or NAM) is in a pivotal registration clinical trial for Parkinson’s disease levodopa induced dyskinesia (PD-LID). Addex is also investigating dipraglurant's therapeutic use in blepharospasm (a type of dystonia), for which a clinical trial is expected to be initiated in Q3 2021. Addex's third clinical program, ADX71149 (mGlu2 positive allosteric modulator or PAM), developed in collaboration with
Contacts:
Chief Executive Officer Telephone: +41 22 884 15 55 PR@addextherapeutics.com | Partner, +44 (0)20 7318 2955 msinclair@halsin.com | Hayden IR (646)-755-7412 james@haydenir.com |
Forward Looking Statements
Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions securityholders and prospective securityholders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
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