IRLAB Therapeutics IRLAB, a clinical-stage biopharmaceutical company discovering and developing novel treatments for the most troublesome symptoms of Parkinson’s disease, announced that the last participating patient has been randomized and entered the ongoing Phase IIb study of lead candidate mesdopetam.
GOTHENBURG, SWEDEN / ACCESSWIRE / September 12, 2022 / IRLAB Therapeutics (STO:IRLAB-A)(FRA:6IRA) IRLAB (Nasdaq Stockholm:IRLAB A), a clinical-stage biopharmaceutical company discovering and developing novel treatments for the most troublesome symptoms of Parkinson’s disease, today announced that the last participating patient has been randomized and entered the ongoing Phase IIb study of lead candidate mesdopetam (IRL790). Mesdopetam, a dopamine D3 antagonist, is being developed in partnership with Ipsen as a treatment for Parkinson’s disease levodopa-induced dyskinesias (PD-LIDs) aiming to improve patient quality of life. Top-line results are expected around the end of the year.
“Considering current conditions when mounting global complexities have affected so many clinical studies, it is a major achievement to complete recruitment for this important study. We have seen a high interest throughout the study, which speaks to the great unmet treatment need for people living with Parkinson’s and dyskinesia,” said Nicholas Waters, EVP and Head of R&D, IRLAB.
The Phase IIb study with mesdopetam is designed as a randomized, double-blind, placebo-controlled study with the aim of evaluating the effects of mesdopetam in patients with Parkinson’s disease affected by levodopa-induced dyskinesias (LIDs). The primary outcome measure is change in daily hours of ON-time without troublesome dyskinesia as assessed with 24-hour patient home diaries. The Phase IIb study is conducted at 46 sites across Europe, Israel and the US, and has now reached its recruitment goal.
“I’m grateful for the confidence and trust that the patients and their families have afforded us in participating in this trial; and for the ongoing diligent work of the clinical development teams as we progress towards the final stages of this trial. I look forward to reporting the top-line data around the end of the year,” said Richard Godfrey, CEO, IRLAB.
Further information will be provided once the final patient has completed the three-month treatment period. This will be followed by database lock and subsequent data analyses before top-line results are communicated around the end of the year. More information can be found on clinicaltrials.gov: NCT04435431 and EudraCT: 2020 -002010-41.
For more information:
Richard Godfrey, CEO
Phone: +46 730 70 69 00
E-mail: richard.godfrey@irlab.se
Nicholas Waters, EVP and Head of R&D
Phone: +46 730 75 77 01
E-mail: nicholas.waters@irlab.se
About mesdopetam
Mesdopetam (IRL790) is a dopamine D3-receptor antagonist being developed for the treatment of levodopa-induced dyskinesias (LIDs), a severe form of troublesome involuntary movements commonly occurring in Parkinson’s disease. Mesdopetam also has potential in treating Parkinson’s disease Psychosis (PD-P). In clinical studies, mesdopetam reduces time spent with troublesome dyskinesia and thereby increases daily ‘good ON-time’ in patients with Parkinson’s. Preclinical studies show that mesdopetam is a potent and efficacious antidyskinetic, and that mesdopetam also has the potential to prevent the development of dyskinesia. In 2021, Ipsen, a specialty pharma company, acquired exclusive global rights to the development and commercialization of mesdopetam.
About Phase IIb study with mesdopetam
The Phase IIb study with mesdopetam is designed as a randomized, double-blind, placebo-controlled study with the aim of evaluating the effects of mesdopetam in patients with Parkinson’s disease affected by levodopa-induced dyskinesias (LIDs). The primary outcome measure is change in daily hours of ON-time without troublesome dyskinesia as assessed with 24-hour patient home diaries. The study is designed to randomize approximately 154 patients distributed across four groups, three dose levels of mesdopetam and a placebo group with approximately 38-39 patients in each group with a treatment period of three months. The study is conducted at clinics and sites in Europe, Israel and in the US.
About IRLAB
IRLAB discovers and develops novel treatments of Parkinson’s disease and other CNS disorders. The company’s most advanced drug candidates, mesdopetam (IRL790) and pirepemat (IRL752), are in Phase IIb and are designed to treat some of the most difficult symptoms related to Parkinson’s . In 2021, Ipsen, a specialty pharma company, acquired exclusive global rights to the development and commercialization of mesdopetam.
IRLAB has discovered and generated all its drug candidates and continues to discover innovative drug candidates for the treatment of CNS disorders through its proprietary systems biology-based Integrative Screening Process (ISP) research platform. In addition to IRLAB’s strong clinical pipeline, the company is also progressing two preclinical programs, IRL942 and IRL757, towards Phase I studies. IRLAB is listed on Nasdaq Stockholm. More information on www.irlab.se.
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https://www.accesswire.com/715500/IRLAB-Completes-Recruitment-in-Phase-IIb-Study-of-Mesdopetam-IRL790-in-Patients-with-Parkinsons-Levodopa-Induced-Dyskinesias
