Last close As at 06/08/2026
SEK1.39
▲ −0.01 (−0.43%)
Market capitalisation
SEK197m
Research: Healthcare
IRLAB has announced that it has activated all 38 sites in the ongoing Phase IIb pirepemat trial. This study is assessing pirepemat as a potential treatment to improve balance and reduce falls in patients with Parkinson’s disease (PD). It is a randomised, double-blind, placebo-controlled study aiming to recruit 165 patients across six European countries. We believe this update is a positive sign that the trial is progressing as anticipated. Management has communicated that patient recruitment is expected to be complete by end-2023, with top-line results in H124, representing a potentially significant catalyst for investor attention, in our view.
Written by
IRLAB Therapeutics |
On track for pirepemat in Phase IIb |
Operational update |
Healthcare |
1 June 2023 |
Share price performance
Business description
Analysts
IRLAB Therapeutics is a research client of Edison Investment Research Limited |
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IRLAB has announced that it has activated all 38 sites in the ongoing Phase IIb pirepemat trial. This study is assessing pirepemat as a potential treatment to improve balance and reduce falls in patients with Parkinson’s disease (PD). It is a randomised, double-blind, placebo-controlled study aiming to recruit 165 patients across six European countries. We believe this update is a positive sign that the trial is progressing as anticipated. Management has communicated that patient recruitment is expected to be complete by end-2023, with top-line results in H124, representing a potentially significant catalyst for investor attention, in our view.
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.
Pirepemat has been designed to improve balance and reduce falls in PD patients (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 with pirepemat (two different doses) versus placebo, 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 also a 50% reduction in fall frequency in PD patients, representing early encouraging signs, in our view.
IRLAB has announced that all trial sites for the Phase IIb trial of pirepemat in PD-Falls are now activated and recruiting patients. There are 38 sites across France, Germany, Poland, the Netherlands, Spain and Sweden. Management expects a steady enrolment pace in coming months, and for recruitment to be completed by end-2023. Patients will receive pirepemat or placebo for 12 weeks, and the company expects to report top-line results in H124. We view the update as encouraging, as it suggests that the trial is on schedule. With pirepemat being IRLAB’s most advanced, active, internally developed clinical asset, we believe that the readouts in H124 may represent a significant upcoming catalyst for the company.
As a reminder, IRLAB is also engaged in the clinical development of mesdopetam for the treatment of levodopa-induced dyskinesias (PD-LIDs). Top-line data from the Phase IIb mesdopetam trial were released in January 2023. IRLAB remains in discussions with Ipsen (the licensee for mesdopetam) regarding future clinical development plans for the drug, and we note that management believes that it will soon be Phase III-ready. IRLAB also recently announced a potential collaboration with the McQuade Center for Strategic Research and Development for preclinical assets IRL757 and IRL942. These were discovered through IRLAB’s proprietary ISP platform, and we believe this external interest is encouraging for IRLAB’s preclinical portfolio.
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Research: Healthcare
Incannex, an Australian-based biotech, has several active studies investigating cannabinoid combinations for a range of conditions, but is also focused on assessing psilocybin for the treatment of generalized anxiety disorder (GAD). In the psychedelics space, Incannex’s ongoing Phase II trial (Psi-GAD) received an encouraging interim review in March 2023, and we see the completion of the study in Q4 CY23 as a significant catalyst. Incannex has also recently announced developments in its psychedelic clinics business through its subsidiary Clarion Clinics Group. In this note, we provide an overview of psychedelics as therapeutics, the GAD market, and Incannex’s position in the emerging field of psychedelic-based therapies. Our valuation for Incannex stands at US$750.7m or US$11.83 per ADR (vs US$745.8m or US$11.75 per ADR previously).