Last close As at 05/08/2026
SEK1.39
▲ −0.01 (−0.43%)
Market capitalisation
SEK197m
Research: Healthcare
IRLAB has secured full global rights ownership of mesdopetam, the company’s leading asset, which was previously out-licensed to Ipsen. All preclinical studies and Phase I, Ib, IIa and IIb trials were completed as part of this collaboration. Full ownership, including associated intangibles and materials, will return to IRLAB in exchange for future (low single-digit) royalties on future product sales. With Ipsen’s support, IRLAB is preparing for an end of Phase II meeting with the FDA, which we view as a key inflection point. Irlab believes mesdopetam is Phase III-ready and the revised arrangement with Ipsen may provide more flexibility to better leverage its ongoing Integrative Screening Process (ISP) platform. Ipsen has supported the preparation for Phase III, including upscale manufacturing, and three Phase III-preparatory Phase I studies: a pharmacokinetic, a drug-to-drug interaction and a mass balance study.
Written by
IRLAB Therapeutics |
Despite shift, mesdopetam still on track for Ph III |
Operational update |
Healthcare |
22 August 2023 |
Share price performance
Business description
Analysts
IRLAB Therapeutics is a research client of Edison Investment Research Limited |
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IRLAB has secured full global rights ownership of mesdopetam, the company’s leading asset, which was previously out-licensed to Ipsen. All preclinical studies and Phase I, Ib, IIa and IIb trials were completed as part of this collaboration. Full ownership, including associated intangibles and materials, will return to IRLAB in exchange for future (low single-digit) royalties on future product sales. With Ipsen’s support, IRLAB is preparing for an end of Phase II meeting with the FDA, which we view as a key inflection point. Irlab believes mesdopetam is Phase III-ready and the revised arrangement with Ipsen may provide more flexibility to better leverage its ongoing Integrative Screening Process (ISP) platform. Ipsen has supported the preparation for Phase III, including upscale manufacturing, and three Phase III-preparatory Phase I studies: a pharmacokinetic, a drug-to-drug interaction and a mass balance study.
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 a reminder, mesdopetam is in clinical development for levodopa-induced dyskinesias (PD-LIDs); top-line data from the Phase IIb trial were released in January 2023. While the study did not meet its primary endpoint (change in daily hours of ‘ON time’ without troublesome dyskinesia versus placebo) with statistical significance, it did meet the secondary efficacy endpoint (demonstrating significant anti-dyskinetic effects measured by the Unified Dyskinesia Rating Scale, UDysRS).
IRLAB also shared a detailed analysis of the Phase IIb trial data, confirming that mesdopetam has a comparable safety and tolerability profile to placebo, and dose-dependent anti-dyskinetic and anti-parkinsonian effects, which may differentiate it from other symptomatic Parkinson’s disease treatments, in our view. We note that dose adjustment was allowed at one point in the study, and importantly, the analysis was conducted on both the actual doses that participants received (protocol-compliant adjusted dose set, PS), as well as the randomised dose assigned (full analysis set, FAS). While in the FAS, the effect of mesdopetam on good ‘ON time’ was not statistically significant, in the PS, a significant and clinically meaningful increase in good ‘ON time’ was observed in the highest tested dose (7.5mg twice daily). Further, the effect of mesdopetam based on UDysRS measurements was more significant in the PS than in the FAS. Collectively, we believe that these results support the further clinical development of mesdopetam. The analysis has enabled a more comprehensive understanding of dose dependency and corresponding treatment effects, as well as providing the basis for dose selection in Phase III.
We believe that the end of Phase II meeting with the FDA could be a major inflection point, as it will determine if the company is able to proceed with a Phase III clinical trial. We currently await communication on timelines for the meeting and anticipate an update during its data presentation and earnings call next week.
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Research: Financials
Bovemij, the unlisted car insurance company in which PB Holding has a 5.3% stake, reported a net profit in H123 of €11.7m, compared to a loss of €3.8m in H122. Lower operational results were more than offset by a better investment result. Bovemij’s results will not directly affect PB Holding’s H123 results, which will be reported on 28 September. These results will largely be driven by the operational costs of the holding, as Bovemij has not paid out a dividend over FY22 in H123. At the end of FY22, PB Holding’s stake in Bovemij had a book value of €3.38 per share.