Last close As at 05/08/2026
SEK1.39
▲ −0.01 (−0.43%)
Market capitalisation
SEK197m
Research: Healthcare
IRLAB Therapeutics reported positive feedback from its FDA end-of-Phase II (EoP2) meeting earlier in the week for mesdopetam. According to management, the meeting was held in a constructive and engaging spirit, and discussions during the meeting suggested alignment between the company and the regulatory authority on the design of a Phase III programme for mesdopetam as a potential treatment for levodopa-induced dyskinesias (PD-LIDs). In our view, this update is a positive sign for further clinical development of IRLAB’s lead asset, and we expect management to share more details on the formal feedback, which is expected in approximately 30 days.
Written by
IRLAB Therapeutics |
Positive FDA mesdopetam outlook following EoP2 |
Regulatory update |
Pharma and biotech |
23 February 2024 |
Share price performance
Business description
Analysts
IRLAB Therapeutics is a research client of Edison Investment Research Limited |
||||||||||||||||||||||||||||||||||||
IRLAB Therapeutics reported positive feedback from its FDA end-of-Phase II (EoP2) meeting earlier in the week for mesdopetam. According to management, the meeting was held in a constructive and engaging spirit, and discussions during the meeting suggested alignment between the company and the regulatory authority on the design of a Phase III programme for mesdopetam as a potential treatment for levodopa-induced dyskinesias (PD-LIDs). In our view, this update is a positive sign for further clinical development of IRLAB’s lead asset, and we expect management to share more details on the formal feedback, which is expected in approximately 30 days.
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 |
0.0 |
(191.3) |
(3.69) |
0.0 |
N/A |
N/A |
12/25e |
0.0 |
(189.7) |
(3.66) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Per the announcement, IRLAB has completed a successful EoP2 meeting with the FDA. Prior to the meeting, management submitted comprehensive information regarding preclinical studies, toxicology, clinical pharmacology and the outcomes of the clinical Phase Ib, Phase IIa and Phase IIb trials. A Phase III programme proposal for mesdopetam was also included. As communicated by management, the FDA aligned with IRLAB’s proposal, including the suggested primary and secondary endpoints, inclusion criteria and safety monitoring. We expect an update from management once it has received formal feedback from the FDA, which is expected up to 30 days after the meeting date.
We remind readers that the latest clinical data for mesdopetam came from the Phase IIb trial, which concluded in January 2023. While mesdopetam did not reach statistical significance in change in daily hours of ‘ON-time’ without troublesome dyskinesia (primary endpoint), it did demonstrate a desirable safety profile and showed significant anti-dyskinetic effects as measured by the UDysRS (secondary endpoint). We note that UDysRS measurements formed the basis of Adamas’s Gocovri approval, the only FDA-approved treatment for PD-LIDs, highlighting the clinical relevance of the scale, in our view. Further, we note that Gocovri is associated with a multitude of side effects (eg hallucinations, peripheral edema, falls, suicidality and depression), which may prompt regulators to view mesdopetam’s safety profile favourably. In August 2023, IRLAB also shared a detailed analysis of the Phase IIb data, confirming that mesdopetam demonstrates dose-dependent anti-dyskinetic and anti-parkinsonian effects.
We currently assume a 40% probability of success for mesdopetam in PD-LIDs, but plan to reassess our assumptions following the formal outcome of the EoP2 meeting. IRLAB recently recapped an active FY23; for a more detailed discussion of the company’s ongoing activities we direct readers to our prior update note.
|
|
Research: TMT
SPA has announced that following a successful trial, UK Power Networks has signed a contract to deploy 1Streetworks, 1Spatial’s traffic plan automation application. This is a landmark win for this key SaaS product, the market opportunity for which management sizes at £400m for UK low-speed roads alone. The contract is worth at least £0.34m over 12 months, but with scope to significantly exceed this over time and UK Power Networks advocacy for the product is notable. A growing pipeline of paid trials with other clients provide further evidence that 1Spatial is moving closer to delivering an acceleration in operationally geared recurring revenue growth.