IRLAB Therapeutics - Q1 report: building up IRL757 - ABG
This is a third party research report and does not necessarily reflect our views or values
New dev collaboration with MSRD on IRL757
Seeking for a partner for mesdopetam's Ph 3
Webcast today at 10:00 CET
MSRD collaboration finances further IRL757 development
Q1 was a very active quarter for IRLAB. In the beginning of February, IRLAB announced an update on pirepemat's Ph 2b study React-PD in PD-Falls (note). The baseline fall rate of the patients recruited into the trial was higher, while the dropout rate in the study was lower than expected. React-PD's completion of enrolment was postponed to Q3'24e (Q1'24). On 20 February, the company conducted the end-of-Ph 2 (EOP2) meeting with the FDA regarding mesdopetam's pivotal Ph 3 trial design. At the end of March, IRLAB shared the FDA feedback (meeting minutes), which align well with IRLAB's Ph 3 design plans (see our previous note). After the reporting period, on 6 May, IRLAB announced the Ph 1 approval for its apathy candidate IRL757 (note). Yesterday, IRLAB announced a development collaboration with MSRD (an Otsuka company) on IRL757 for the treatment of apathy in Alzheimer's and Parkinson's disease. The agreement builds on an evaluation agreement MSRD/IRLAB had since May'23. According to the agreement, IRLAB will receive USD 3m upfront and milestone payments of up to USD 5.5m. MSRD will fund the drug development activities during the term of the agreement, including a safety and efficacy signal finding study (clinical proof of concept). If certain triggering events are reached, IRLAB and MSRD have the possibility to expand the collaboration, subject to negotiations of a new agreement. IRLAB will retain the commercial rights to the drug and if the collaboration agreement is not expanded MSRD is eligible to low single-digit royalty payments. IRL757's Ph 1 is already fully funded by the Michael J. Fox foundation grant received late last year.
Seeking for a partner for mesdopetam's Ph 3
Webcast today at 10:00 CET
MSRD collaboration finances further IRL757 development
Q1 was a very active quarter for IRLAB. In the beginning of February, IRLAB announced an update on pirepemat's Ph 2b study React-PD in PD-Falls (note). The baseline fall rate of the patients recruited into the trial was higher, while the dropout rate in the study was lower than expected. React-PD's completion of enrolment was postponed to Q3'24e (Q1'24). On 20 February, the company conducted the end-of-Ph 2 (EOP2) meeting with the FDA regarding mesdopetam's pivotal Ph 3 trial design. At the end of March, IRLAB shared the FDA feedback (meeting minutes), which align well with IRLAB's Ph 3 design plans (see our previous note). After the reporting period, on 6 May, IRLAB announced the Ph 1 approval for its apathy candidate IRL757 (note). Yesterday, IRLAB announced a development collaboration with MSRD (an Otsuka company) on IRL757 for the treatment of apathy in Alzheimer's and Parkinson's disease. The agreement builds on an evaluation agreement MSRD/IRLAB had since May'23. According to the agreement, IRLAB will receive USD 3m upfront and milestone payments of up to USD 5.5m. MSRD will fund the drug development activities during the term of the agreement, including a safety and efficacy signal finding study (clinical proof of concept). If certain triggering events are reached, IRLAB and MSRD have the possibility to expand the collaboration, subject to negotiations of a new agreement. IRLAB will retain the commercial rights to the drug and if the collaboration agreement is not expanded MSRD is eligible to low single-digit royalty payments. IRL757's Ph 1 is already fully funded by the Michael J. Fox foundation grant received late last year.