Introduction
Dipraglurant, developed by Addex Therapeutics, is a metabotropic glutamate receptor subtype 5 negative allosteric modulator (mGlu5 NAM) that has been making significant strides in the treatment of various neurological disorders. Here, we will delve into the development updates and market projections for this promising drug candidate.
Mechanism of Action
Dipraglurant works by selectively inhibiting the metabotropic glutamate receptor 5 (mGluR5), a Class C G-Protein Coupled Receptor (GPCR). This mechanism holds potential for treating conditions where mGluR5 is implicated, such as Parkinson’s disease levodopa-induced dyskinesia (PD-LID), dystonia, and other movement disorders[2][4].
Clinical Trials and Development Updates
Phase IIa Clinical Study in PD-LID
In a Phase IIa clinical study, dipraglurant demonstrated positive top-line data in patients suffering from PD-LID. The study showed that dipraglurant met its primary objectives, including a good safety and tolerability profile, and statistically significant reductions in LID severity. The drug reduced both dystonia and chorea, the two major components of LID[2].
Ongoing Phase 2b/3 Pivotal Clinical Trial
Addex has been conducting a placebo-controlled Phase 2b/3 pivotal clinical trial of dipraglurant in PD-LID patients since June 2021. This trial is expected to enroll approximately 140 patients at 50 sites in the US, with topline results scheduled for the first half of 2023[1].
Feasibility Study in Blepharospasm
Although a small Phase 2a feasibility study of dipraglurant in patients with blepharospasm was inconclusive and did not meet all its objectives, it provided valuable insights into the patient population and clinical rating scales. These insights will inform future development strategies[1].
Market Projections and Potential
Market Opportunity for PD-LID
The potential market opportunity for dipraglurant in treating PD-LID is substantial, with estimates suggesting it could exceed $1 billion. PD-LID is recognized as a significant unmet medical need by regulatory authorities, patient advocacy groups like The Michael J. Fox Foundation, and key opinion leaders[2][3].
Peak Sales Projections
According to the valuationLAB report, peak sales for dipraglurant as a treatment for PD-LID could reach up to $2 billion. Potential label expansions into other indications, such as non-parkinsonian dystonias, PD motor and non-motor symptoms, and other movement disorders, could further increase its market potential[3].
Additional Therapeutic Applications
Non-Motor Symptoms of Parkinson’s Disease
Recent data have shown that dipraglurant could have beneficial effects on non-motor symptoms (NMS) experienced by Parkinson’s patients, in addition to its established positive effects on dyskinesias. This broadens the potential therapeutic applications of the drug[4].
Dystonia and Other Movement Disorders
Dipraglurant is also being investigated for its therapeutic use in dystonia, with support from the Dystonia Medical Research Foundation (DMRF). Its potential in treating other movement disorders is another area of ongoing research[3].
Strategic Partnerships and Funding
Addex has secured strategic partnerships to advance its drug candidates. For instance, the GABAB PAM program has been licensed to Indivior PLC for the development of drug candidates focused on substance use disorder. The company has also received support from governmental organizations and patient advocacy groups, such as The Michael J. Fox Foundation and the Swiss Commission for Innovation and Technology (CTI)[3][4].
Future Development
Addex is evaluating the best and most efficient way forward for the future development of dipraglurant in multiple potential therapeutic applications. With several clinical and preclinical programs advancing, the company remains committed to its allosteric modulator approach to drug discovery and development[1][4].
Key Takeaways
- Clinical Success: Dipraglurant has shown positive results in Phase IIa clinical studies for PD-LID, demonstrating safety, tolerability, and efficacy.
- Market Potential: The drug has a significant market opportunity, with potential peak sales exceeding $2 billion for PD-LID and additional indications.
- Broad Therapeutic Applications: Dipraglurant may benefit patients with non-motor symptoms of Parkinson’s disease and other movement disorders.
- Strategic Partnerships: Addex has secured partnerships and funding to advance its drug candidates.
FAQs
What is dipraglurant and how does it work?
Dipraglurant is a metabotropic glutamate receptor subtype 5 negative allosteric modulator (mGlu5 NAM) that selectively inhibits the mGluR5 receptor, a Class C G-Protein Coupled Receptor (GPCR).
What is the current status of dipraglurant's clinical trials?
Dipraglurant is currently in a Phase 2b/3 pivotal clinical trial for PD-LID, with topline results expected in the first half of 2023. A small Phase 2a feasibility study in blepharospasm was inconclusive.
What are the potential market opportunities for dipraglurant?
The potential market opportunity for dipraglurant in treating PD-LID is estimated to exceed $1 billion, with peak sales projections up to $2 billion. Additional indications could further increase its market potential.
What other therapeutic applications is dipraglurant being explored for?
Dipraglurant is being investigated for its therapeutic use in non-parkinsonian dystonias, PD motor and non-motor symptoms, and other movement disorders.
Who are the key partners supporting the development of dipraglurant?
Addex has partnerships with Janssen Pharmaceuticals, Inc., Indivior PLC, and support from organizations like The Michael J. Fox Foundation and the Swiss Commission for Innovation and Technology (CTI).
What are the next steps in the development of dipraglurant?
Addex is evaluating the best and most efficient way forward for the future development of dipraglurant in multiple potential therapeutic applications.
Sources
- Addex Therapeutics. Addex Provides Update on Dipraglurant Blepharospasm Phase 2 Feasibility Clinical Study. Retrieved from https://www.addextherapeutics.com/en/investors/press-releases/addex-provides-update-dipraglurant-blepharospasm-phase-2-feasibility-clinical-study/
- Clinical Trials Arena. Dipraglurant drug meets endpoints: Addex reports. Retrieved from https://www.clinicaltrialsarena.com/uncategorized/newsdipraglurant-drug-meets-endpoints-addex-reports/
- Swiss Biotech. Addex Therapeutics Equity Research Report Update Issued by ValuationLAB. Retrieved from https://www.swissbiotech.org/listing/addex-therapeutics-equity-research-report-update-issued-by-valuationlab/
- Biospace. Addex Publishes Dipraglurant Data Showing In Vivo Efficacy on Motor and Non-Motor Symptoms of Parkinson’s Disease. Retrieved from https://www.biospace.com/addex-publishes-dipraglurant-data-showing-in-vivo-efficacy-on-motor-and-non-motor-symptoms-of-parkinson-s-disease/
Last updated: 2024-12-30
