Currency in SEK
Last close As at 27/03/2023
SEK11.00
▲ −0.22 (−1.96%)
Market capitalisation
SEK581m
Research: Healthcare
IRLAB Therapeutics has announced top-line data from its Phase IIb trial investigating mesdopetam as a treatment for Parkinson’s disease levodopa-induced dyskinesias (PD-LIDs). The drug did not meet the primary outcome of the study, change in daily hours of ‘ON time’ (the length of time a patient does not have symptoms) without troublesome dyskinesia compared to placebo with statistical significance. However, the results confirmed the safety and tolerability of mesdopetam and met the secondary efficacy endpoint in demonstrating significant anti-dyskinetic effects as measured by the Unified Dyskinesia Rating Scale (UDysRS), a clinically recognised scale for measuring dyskinesias. We believe the importance of the secondary endpoint should not be overlooked; FDA approval of Gocovri in PD-LID was based on two pivotal studies assessing changes in the UDysRS as the primary outcome, demonstrating its clinical relevance. IRLAB’s stock dropped c 60% following the news, which likely reflects market uncertainty over mesdopetam’s future clinical development. Based on this news, our valuation and estimates are under review.
IRLAB Therapeutics |
Mesdopetam Phase IIb top-line data |
Clinical trial update |
Pharma and biotech |
18 January 2023 |
Share price performance Business description
Analysts
IRLAB Therapeutics is a research client of Edison Investment Research Limited |
IRLAB Therapeutics has announced top-line data from its Phase IIb trial investigating mesdopetam as a treatment for Parkinson’s disease levodopa-induced dyskinesias (PD-LIDs). The drug did not meet the primary outcome of the study, change in daily hours of ‘ON time’ (the length of time a patient does not have symptoms) without troublesome dyskinesia compared to placebo with statistical significance. However, the results confirmed the safety and tolerability of mesdopetam and met the secondary efficacy endpoint in demonstrating significant anti-dyskinetic effects as measured by the Unified Dyskinesia Rating Scale (UDysRS), a clinically recognised scale for measuring dyskinesias. We believe the importance of the secondary endpoint should not be overlooked; FDA approval of Gocovri in PD-LID was based on two pivotal studies assessing changes in the UDysRS as the primary outcome, demonstrating its clinical relevance. IRLAB’s stock dropped c 60% following the news, which likely reflects market uncertainty over mesdopetam’s future clinical development. Based on this news, our valuation and estimates are under review.
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 |
23.1 |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
While it is disappointing that the study did not meet its primary objective with statistical significance, encouragement can be taken from the trial meeting the UDysRS secondary efficacy measure. As measured by the UDysRS, mesdopetam (7.5mg) displayed positive anti-dyskinetic effects with onset of action after four weeks, at eight weeks and then continuing for the duration of the 12-week study. This effect was further supported by an improvement in observed disability associated with dyskinesia. Additionally, daily hours in OFF time were dose-dependent and a decrease compared to placebo was observed at the 7.5mg dose.
While we caution direct read-across between studies, it should be noted that the UDysRS measure was used as the primary efficacy endpoint in two pivotal Phase III studies (EASE LID and EASE LID 3) that led to the approval of Adamas Pharmaceutical’s Gocovri (amantadine), the only FDA-approved treatment for PD-LIDs. Unlike mesdopetam, Gocovri is associated with severe side effects, including peripheral edema, falls, suicidality and depression.
IRLAB has licensed the global rights for mesdopetam to Ipsen. As part of the agreement, IRLAB would fund the development of mesdopetam until the Phase IIb top-line results were reported, with Ipsen assuming full responsibility for any further development. We await further communication to understand the impact of the latest data and how it might define Ipsen’s future development strategy for mesdopetam.
|
|
Research: Industrials
The memorandum of understanding (MOU) signed with Norwegian Hydrogen is the latest significant step in Provaris Energy’s development of a cost-effective green hydrogen (GH2) transportation solution for Europe. The first Norwegian commercial hydrogen export volumes are likely to become available around the time of Provaris’s H2Neo carrier’s maiden voyage in 2027, neatly linking with the European Union’s REPowerEU ambition to develop a hydrogen industry.
Get access to the very latest content matched to your personal investment style.