Subject: FDA
IRLAB's mesdopetam IND accepted by the US FDA
STOCKHOLM, Oct. 1, 2020 /PRNewswire/ -- IRLAB (Nasdaq Stockholm: IRLAB A) announced today that the U.S. Food and Drug Administration (FDA) has accepted IRLAB's investigational new drug application (IND) for the drug candidate mesdopetam (IRL790). The acceptance of the IND will allow IRLAB to include US patients in the upcoming clinical trial in Parkinson's disease in accordance with the study protocol submitted with the IND application. The planned Phase IIb/III study for mesdopetam will thus include hospitals and enrol patients in the US and Europe. Mesdopetam is in development for the treatment of levodopa-induced dyskinesias in Parkinson's disease, PD-LIDs, with the objective to increase daily good ON-time.
"We are pleased to receive acceptance of the IND. The FDA clearance of the IND is a quality stamp on the mesdopetam project and validates mesdopetam as a safe and tolerable drug candidate. It also means that we now expand our clinical development operations to the US, an important strategic goal for the company, " said Nicholas Waters, CEO at IRLAB. "We believe that mesdopetam has a very good chance to offer a completely new and better treatment for the large group of Parkinson's patients experiencing daily complications and reduced quality of life due to levodopa-induced dyskinesia."
"The treatment effects seen in the previous Phase IIa study exceeds the results for other treatment strategies in troublesome dyskinesias. When mesdopetam was given in addition to standard Parkinson medication, patients experienced considerably longer periods of good daily motor function without aggravated involuntary movements improving the daily function in these severely affected patients. This is highly relevant since involuntary, levodopa-induced dyskinesia is a major problem In Parkinson's disease today preventing optimal individual treatment", says Joakim Tedroff, CMO at IRLAB.
The strategy for the Phase IIb/III study has been developed in collaboration with regulatory and clinical experts. The strategy is based on the results from IRLAB's successful Phase I, Phase Ib and Phase II studies with mesdopetam as well as the common use of patient diaries in previous marketing authorizations granted by regulatory authorities for treatments in Parkinson's disease.
The Phase IIb/III study preparations are progressing according to plan with parallel application processes to regulatory authorities and ethics committees ongoing in selected European countries. The objective is to start patient recruitment during Q4 2020.
This disclosure contains information that IRLAB Therapeutics AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 01-10-2020 08:20 CET.
For more information
Nicholas Waters, CEO
Phone: +46 730 75 77 01
E-mail: [email protected]
Joakim Tedroff, CMO
Phone: +46 70 760 16 91
E-mail: [email protected]
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IRLAB PR mesdopetam IND - ENG |
SOURCE IRLAB Therapeutics AB
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