Currency in SEK
Last close As at 04/02/2023
SEK11.90
▲ −0.02 (−0.17%)
Market capitalisation
SEK617m
Research: Healthcare
IRLAB Therapeutics has announced that the final patient has completed the treatment period and follow-up visit in its Phase IIb study investigating mesdopetam in the treatment of patients with Parkinson’s disease levodopa-induced dyskinesias (PD-LIDs). We see this as a significant milestone for the trial as IRLAB now looks to complete the data package following completion of the treatment period and to report top-line results in mid-January 2023. We had previously communicated that initial top-line readouts from the study would be disclosed around Q422. However, we do not see this as having any major impact on mesdopetam’s developmental timeline in PD-LIDs. We value IRLAB at SEK6.72bn or SEK129.8 per share.
IRLAB Therapeutics |
Phase IIb trial patient follow-up as expected |
Clinical study update |
Pharma and biotech |
15 December 2022 |
Share price performance Business description
Analysts
IRLAB Therapeutics is a research client of Edison Investment Research Limited |
IRLAB Therapeutics has announced that the final patient has completed the treatment period and follow-up visit in its Phase IIb study investigating mesdopetam in the treatment of patients with Parkinson’s disease levodopa-induced dyskinesias (PD-LIDs). We see this as a significant milestone for the trial as IRLAB now looks to complete the data package following completion of the treatment period and to report top-line results in mid-January 2023. We had previously communicated that initial top-line readouts from the study would be disclosed around Q422. However, we do not see this as having any major impact on mesdopetam’s developmental timeline in PD-LIDs. We value IRLAB at SEK6.72bn or SEK129.8 per share.
Year end |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/20 |
0.4 |
(91.4) |
(1.92) |
0.0 |
N/A |
N/A |
12/21 |
207.9 |
91.1 |
1.76 |
0.0 |
22.2 |
N/A |
12/22e |
62.1 |
(110.3) |
(2.13) |
0.0 |
N/A |
N/A |
12/23e |
0.3 |
(121.2) |
(2.34) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
PD-LIDs is a condition often observed in Parkinson’s patients who are being treated with levodopa, a dopamine replacement agent, to manage the symptoms of the disease. As a reminder, the Phase IIb study for mesdopetam in PD-LIDs is a randomised, double-blind, placebo-controlled study being conducted at 46 sites across Europe, the United States and Israel comprising 156 patients. The primary outcome from the study is a change in daily hours of ‘ON-time’ (the length of time a patient does not have symptoms) without troublesome dyskinesia.
Management believes that a c one-hour increase in ‘good ON-time’ through a reduction in ‘bad ON-time’ (when a patient experiences negative symptoms) would represent a clinically meaningful result. Data from IRLAB’s previously conducted Phase IIa double-blind, placebo-controlled study improved good ON-time through the reduction of bad ON-time in patients by c 2.8 hours compared to c 1.5 hours for existing standard of care, providing encouragement for the Phase IIb efficacy study, in our view.
In July 2021, IRLAB licensed mesdopetam’s global rights to Ipsen for an upfront payment of US$28m, up to US$335m in potential milestones and low double-digit royalties on sales. Ipsen will assume responsibility for the drug’s clinical development programme through registration and global commercialisation, should positive Phase IIb data be reported.
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Research: Industrials
The class ‘Design Approval’ for Provaris’ H2Neo compressed green hydrogen carrier has been issued by the American Bureau of Shipping (ABS). This is a key step for Provaris, as discussed in our recent Q3 activity update note. The approval opens the way for Provaris, assisted by shipping expert Clarksons, to seek a shipyard to quote for and construct the carrier. The novel vessel design gives Provaris first-mover advantage in large-scale hydrogen transport solutions and paves the way for the much more cost-effective H2Max vessel, which has five-times the capacity.
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