Last close As at 05/08/2026
SEK1.39
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Market capitalisation
SEK197m
Research: Healthcare
IRLAB Therapeutics has provided an update on its ongoing Phase IIb clinical trial for pirepemat, which has been designed to improve balance and reduce falls in patients with Parkinson’s disease (PD-Falls). The independent data and safety monitoring board (DSMB) for the study has unanimously recommended that the trial should continue without any modifications, after it reviewed the safety and integrity of the data from the initial 25 participants completing the study. Management expects patient recruitment and randomisation to be completed by end 2023 and, following a 12-week treatment period, top-line results are expected in H124, consistent with prior guided timelines for the trial. With pirepemat being IRLAB’s most advanced, active, internally developed clinical asset, we believe that the H124 readouts may represent a significant upcoming catalyst for the company.
Written by
IRLAB Therapeutics |
Phase IIb pirepemat obtains safety milestone |
Clinical study update |
Healthcare |
18 July 2023 |
Share price performance
Business description
Analysts
IRLAB Therapeutics is a research client of Edison Investment Research Limited |
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IRLAB Therapeutics has provided an update on its ongoing Phase IIb clinical trial for pirepemat, which has been designed to improve balance and reduce falls in patients with Parkinson’s disease (PD-Falls). The independent data and safety monitoring board (DSMB) for the study has unanimously recommended that the trial should continue without any modifications, after it reviewed the safety and integrity of the data from the initial 25 participants completing the study. Management expects patient recruitment and randomisation to be completed by end 2023 and, following a 12-week treatment period, top-line results are expected in H124, consistent with prior guided timelines for the trial. With pirepemat being IRLAB’s most advanced, active, internally developed clinical asset, we believe that the H124 readouts may represent a significant upcoming catalyst for the company.
Year end |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/21 |
207.9 |
91.1 |
1.76 |
0.0 |
N/A |
N/A |
12/22 |
61.3 |
(113.1) |
(2.18) |
0.0 |
N/A |
N/A |
12/23e |
0.2 |
(208.4) |
(4.02) |
0.0 |
N/A |
N/A |
12/24e |
0.2 |
(190.2) |
(3.67) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
As discussed in our prior note, pirepemat is being investigated as a potential treatment to improve balance and reduce PD-Falls. This is a serious consequence of PD with no treatments yet available for these specific symptoms, representing a significant opportunity for IRLAB. The primary outcome measure for the Phase IIb trial is change in frequency of falls, as well as safety and tolerability, with two different doses of pirepemat versus placebo, to select a dose for Phase III studies. The fall frequency is assessed by a fall diary from baseline to 12 weeks of treatment. We note that pirepemat showed preliminary indications of efficacy in PD-Falls in the prior Phase IIa trial (n=32). This study demonstrated good safety and tolerability and a 50% reduction in fall frequency in PD patients, representing early encouraging signs, in our view.
IRLAB has announced that the DSMB has evaluated data from the first 25 patients completing treatment in the Phase IIb trial and it recommended the study continue according to the approved protocol, without modifications. We view this as a positive sign that the trial is progressing as anticipated and that pirepemat has the potential to be a safe and effective treatment for reducing PD-Falls. The study is active at 38 sites across France, Germany, Poland, the Netherlands, Spain and Sweden and management expects a steady enrolment pace in the coming months, with recruitment completed by end 2023. Patients will receive pirepemat or a placebo for 12 weeks and IRLAB expects to report top-line results in H124, potentially representing a significant upcoming catalyst for investor attention, in our view.
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