Last close As at 05/08/2026
SEK1.39
▲ −0.01 (−0.43%)
Market capitalisation
SEK197m
Research: Healthcare
IRLAB Therapeutics has successfully completed the second and final of two pre-determined safety and data integrity reviews for its ongoing Phase IIb clinical trial (React PD) for pirepemat. The study will assess the ability to improve balance and reduce falls in patients with Parkinson’s disease (PD-Falls). The independent data and safety monitoring board (DSMB) has unanimously recommended that the React PD study should continue without any changes. Hence, and in line with previous guidance, patient recruitment remains on track to be completed in Q324, and we expect top-line results to be shared in Q424 or Q125, which would be after the three-month treatment period, follow-up visits and required data analyses.
Written by
IRLAB Therapeutics |
Pirepemat passes Phase IIb DSMB safety hurdle |
Clinical update |
Pharma and biotech |
3 July 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 successfully completed the second and final of two pre-determined safety and data integrity reviews for its ongoing Phase IIb clinical trial (React PD) for pirepemat. The study will assess the ability to improve balance and reduce falls in patients with Parkinson’s disease (PD-Falls). The independent data and safety monitoring board (DSMB) has unanimously recommended that the React PD study should continue without any changes. Hence, and in line with previous guidance, patient recruitment remains on track to be completed in Q324, and we expect top-line results to be shared in Q424 or Q125, which would be after the three-month treatment period, follow-up visits and required data analyses.
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 |
32.6 |
(160.0) |
(3.08) |
0.0 |
N/A |
N/A |
12/25e |
0.0 |
(185.5) |
(3.58) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
IRLAB has announced that the DSMB has completed its second (and final) safety and data integrity review for the React PD trial (it passed the first review in July 2023), and recommended that the study should continue according to the approved protocol without modifications, which is a positive sign that the company’s plans for the trial are progressing as anticipated. Patient enrolment is due to be completed in Q324, and we expect top-line results from Q424 to Q125, a potentially sizeable upcoming catalyst for IRLAB, in our view.
As a reminder, pirepemat is a pre-frontal cortex enhancer designed to improve balance and reduce falls for PD patients. The React PD trial is a randomised, double-blind, placebo-controlled Phase IIb study investigating the safety, tolerability and potential efficacy of pirepemat at two different doses, and aiming to identify the optimal dose for Phase III. The primary outcome measure is change in frequency of falls based on a fall diary from baseline to 12 weeks of treatment. The trial is active at 38 sites across France, Poland, the Netherlands, Spain, Sweden and Germany. Impaired balance is a serious and common consequence of PD, and we note that levodopa, the current mainstay for PD treatment, has limited beneficial effect on the risk of falls in PD patients, highlighting the significant unmet need. Given the lack of available treatment options for these specific symptoms, we believe there is a sizeable opportunity for IRLAB in this space.
IRLAB’s two other clinical-stage assets are mesdopetam and IRL757. Mesdopetam holds potential to address levodopa-induced dyskinesias (PD-LIDs), and is Phase III-ready after a positive FDA end-of-Phase II meeting (announced in March 2024). Management is in discussions with potential collaboration/out-licensing partners. IRL757 is in the earlier stages of clinical development as a potential treatment for apathy, having recently entered the clinic (May 2024). The Phase I safety study is funded by the Michael J Fox Foundation and the programme is funded through to proof-of-concept by the McQuade Center for Strategic Research and Development, which are encouraging signs of external validation, in our view.
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Research: Consumer
Topps Tiles’ (TPT’s) brand strength continues to shine through with ongoing market share gains versus a weak repair, maintenance and improvement sector. There is also some encouragement that overall revenue trends were relatively unchanged through Q324, with no deterioration versus what was reported for the first seven weeks, albeit it remains challenging overall. For the individual group companies, the trends and narrative are consistent with recent updates: Omni-channel remains weak given the difficult but slowly improving macroeconomic environment; Online Pure Play continues to grow strongly; and Parkside (Commercial) remains profitable despite the challenging backdrop. The trading update also indicates progress on the initiatives announced as part of the updated long-term strategy and new financial goal, Mission 365, which are expected to generate significant revenue (£365m) and profit growth (adjusted PBT margin of 8–10%) even with management’s assumption of limited recovery in the market. A cyclical recovery would be additionally helpful to estimates and, no doubt, for sentiment towards the share price. Our forecasts are under review and will be updated shortly.