IRLAB expands Phase IIb/III PD-LIDs study with mesdopetam to support Phase III program and expects completion of enrollment during the summer
IRLAB (Nasdaq Stockholm: IRLAB A) today announced that the ongoing Phase IIb/III study has been expanded to include 154 patients aiming to provide strong data supporting the design of the pivotal Phase III program and subsequent marketing authorization applications in the US, and globally, led by partner Ipsen. Patient enrollment in the Phase IIb/III study is expected to be completed during the summer, and thus, the last patient completes treatment in late fall 2022. Top-line results be communicated subsequent to database lock and data analyses, expected in Q4 2022.
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IRLAB (Nasdaq Stockholm: IRLAB A) today announced that the ongoing Phase IIb/III study has been expanded to include 154 patients aiming to provide strong data supporting the design of the pivotal Phase III program and subsequent marketing authorization applications in the US, and globally, led by partner Ipsen. Patient enrollment in the Phase IIb/III study is expected to be completed during the summer, and thus, the last patient completes treatment in late fall 2022. Top-line results will be communicated subsequent to database lock and data analyses, expected in Q4 2022.
“Together with our partner Ipsen, we decided to expand the number of clinical sites to support patient enrollment during the spring and early summer and to take advantage of the interest in the study. We decided to expand the study to 154 participants, from the initially planned 140. The interest from patients and clinicians has remained high and consistent, which is encouraging given the imposed restrictions due to the covid-19 pandemic across many regions during the course of the study” said Nicholas Waters, EVP and Head of R&D at IRLAB.
“I am pleased to share that observations in the blinded safety data during the study thus far is in alignment with results from the earlier completed Phase Ib and Phase IIa studies. This is a positive indication for patients as well as all involved in the development of mesdopetam. There is a major need for treatment in Parkinson’s disease dyskinesia and our commitment to bring hope for a life without treatment-related complications to people living with Parkinson’s and dyskinesia remains,” added Joakim Tedroff, CMO at IRLAB.
To facilitate the planned increase in the number of study participants and meet the projected timeline, the study has also been expanded with additional clinical sites in the US and Poland. The study now comprises 16 sites in the US and 30 throughout Europe and Israel. Recruitment has successfully progressed during the course of the study period and enrollment is expected to be completed during the summer.
A further announcement will be made once the patient enrollment is completed and the Phase IIb/III study’s final participant has been randomized into the trial. This will be followed by a three-month treatment period and subsequent database lock and data analyses before top-line results are communicated. More information can be found on clincialtrials.gov (NCT04435431).
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