Last close As at 05/08/2026
SEK1.39
▲ −0.01 (−0.43%)
Market capitalisation
SEK197m
Research: Healthcare
IRLAB Therapeutics has announced the completion of patient enrolment for the Phase IIb trial (React PD) assessing pirepemat’s ability to improve balance and reduce falls in Parkinson’s disease patients (PD-Falls). The company also noted that a reduction in falls has been observed thus far in the patient population that has completed the treatment regimen, adding to the optimism about the potential outcome of the study. However, we caution that as this is a placebo-controlled, double-blind trial, it cannot yet be concluded that the effect is due to pirepemat. Nevertheless, the update is an encouraging sign for the patients enrolled in the trial, and we continue to believe that the top-line results represent a major upcoming catalyst for IRLAB. The readout is expected at the end of Q125, after all patients have finished the study and the full analysis has been completed.
IRLAB Therapeutics |
Pirepemat Phase IIb trial completes enrolment |
Clinical update |
Pharma and biotech |
1 October 2024 |
Share price performance
Business description
Analysts
IRLAB Therapeutics is a research client of Edison Investment Research Limited |
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IRLAB Therapeutics has announced the completion of patient enrolment for the Phase IIb trial (React PD) assessing pirepemat’s ability to improve balance and reduce falls in Parkinson’s disease patients (PD-Falls). The company also noted that a reduction in falls has been observed thus far in the patient population that has completed the treatment regimen, adding to the optimism about the potential outcome of the study. However, we caution that as this is a placebo-controlled, double-blind trial, it cannot yet be concluded that the effect is due to pirepemat. Nevertheless, the update is an encouraging sign for the patients enrolled in the trial, and we continue to believe that the top-line results represent a major upcoming catalyst for IRLAB. The readout is expected at the end of Q125, after all patients have finished the study and the full analysis has been completed.
Year end |
Revenue (SEKm) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/22 |
61.3 |
(113.1) |
(2.18) |
0.0 |
N/A |
N/A |
12/23 |
5.7 |
(177.8) |
(3.43) |
0.0 |
N/A |
N/A |
12/24e |
75.6 |
(154.8) |
(2.98) |
0.0 |
N/A |
N/A |
12/25e |
27.5 |
(180.9) |
(3.49) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
React PD is a randomised (placebo; or 300mg pirepemat/day; or 600mg pirepemat/day), double-blind, placebo-controlled study designed to evaluate the company’s second asset as a potential treatment for PD-Falls. While it was initially intended to recruit 165 participants, in February 2024, an update communicated that an assessment of the baseline data showed that subjects were two to three times more likely to experience falls than expected, and that individual fall rates were notably consistent throughout the one-month study run-in prior to starting treatment. This led to a decision to reduce the number of participants required, while retaining the pre-agreed level of statistical power. The amendment was subsequently accepted by regulators.
According to the announcement, patient enrolment has now been completed for the React PD trial, in line with the most recent guided timelines, and management has confirmed that the top-line results are expected at the end of Q125, following all patients completing the study, data management, database locking and analysis of the data. As part of this update, management highlighted that with over 100 patients included in the study to date, the blinded data so far have demonstrated that the number of falls for the population has reduced by approximately one-third compared to the baseline period. While this is positive for the patients enrolled in the trial, as the study is blinded, we cannot ascertain at this time whether the reduction in falls is due to the influence of pirepemat. Detailed conclusions will be drawn when the trial has been completed and may be a significant inflection point for IRLAB. Management noted that a clinically meaningful difference would be a c 25% reduction in fall frequency in those treated with pirepemat, compared to placebo. Should the results be positive, we expect IRLAB to move ahead with a Phase III programme in PD-Falls, with the optimal dose determined by the React PD results.
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