Last close As at 05/08/2026
SEK1.39
▲ −0.01 (−0.43%)
Market capitalisation
SEK197m
Research: Healthcare
IRLAB Therapeutics has been granted a new patent in Europe for its lead asset, Phase-III ready mesdopetam, which potentially extends its market exclusivity beyond the previous 2037 expiry. The updated patent relates to a new salt of the drug (which has been used during the ongoing clinical development) and the process for its preparation, extending protection to 2040. Mesdopetam is IRLAB’s most advanced asset, targeting levodopa-induced dyskinesias in Parkinson’s disease (PD-LIDs), a debilitating condition inflicting over 30% of the PD patient population. Following IRLAB’s successful end-of-Phase II (EoP2) meeting with the FDA, we believe that Phase III trials could start as early as Q424 or Q125, depending on partnership discussions. We view this as the most significant upcoming catalyst for the company.
Written by
IRLAB Therapeutics |
New mesdopetam patent strengthens IP portfolio |
Regulatory update |
Pharma and biotech |
5 September 2024 |
Share price performance
Business description
Analysts
IRLAB Therapeutics is a research client of Edison Investment Research Limited |
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IRLAB Therapeutics has been granted a new patent in Europe for its lead asset, Phase-III ready mesdopetam, which potentially extends its market exclusivity beyond the previous 2037 expiry. The updated patent relates to a new salt of the drug (which has been used during the ongoing clinical development) and the process for its preparation, extending protection to 2040. Mesdopetam is IRLAB’s most advanced asset, targeting levodopa-induced dyskinesias in Parkinson’s disease (PD-LIDs), a debilitating condition inflicting over 30% of the PD patient population. Following IRLAB’s successful end-of-Phase II (EoP2) meeting with the FDA, we believe that Phase III trials could start as early as Q424 or Q125, depending on partnership discussions. We view this as the most significant upcoming catalyst for the company.
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 |
75.6 |
(154.8) |
(2.98) |
0.0 |
N/A |
N/A |
12/25e |
27.5 |
(180.9) |
(3.49) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Mesdopetam is a novel dopamine D3 antagonist being developed for PD-LIDs, a debilitating complication of long-term use of the current standard-of-care treatment, levodopa. According to published research, c 80% of all PD patients eventually develop LID, with 30% developing it after only three years of levodopa treatment. Despite ongoing efforts in the field, the indication remains underserved, with Adamas Pharmaceuticals’ GOCOVRI (an oral long-acting formulation of amantadine) being the only FDA-approved pharmacotherapy for its treatment. However, debilitating side effects (such as psychosis) have limited its use, and there are currently no approved drugs for PD-LIDs outside of the United States.
Mesdopetam is a new chemical entity discovered by IRLAB’s ISP research platform and has been developed in-house. The drug already had a strong IP position with composition of matter patent protection to 2037. The updated patent relates to a new salt of the drug (used throughout the clinical development programme and will be the salt of mesdopetam in the formulation used in the final product, subject to approval) and the process for its preparation, and extends the drug’s patent protection to 2040 (which may be further extended into the early 2040s with supplementary protection certificates or patent term extension).
Following a positive EoP2 meeting with the FDA, IRLAB is preparing to commence Phase III studies for mesdopetam from Q424/Q125, with the precise timing contingent on finalising a partnership deal. The Phase III programme will be double-blinded and placebo-controlled, involving two parallel studies recruiting in total c 250 participants. Patients will be treated for 12 weeks at 7.5mg BID. IRLAB will also undertake an open-label extension for participants from the Phase III studies, aiming to generate longer-term data (at least one year) from at least 100 patients to support its registrational plans. Following the FDA thumbs up, management is now preparing for discussions with European regulatory authorities to ratify the Phase III design. We expect the next key inflection point for IRLAB to be the finalisation of a potential partner, prior to commencement of the Phase III programme.
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Research: Healthcare
Argent BioPharma is a clinical-stage specialty biopharma company developing therapeutics targeting areas of unmet need. Currently focused on CNS conditions and immunology, Argent has a broad pipeline of assets, led by CannEpil (drug-resistant epilepsy), CimetrA (acute lung disease) and CogniCann (CNS disorders). The first two are available under special access schemes in markets such as the UK, US and EU, generating early revenue streams as well as real-world evidence, which should aid regulatory outcomes. Argent has a strong internal IP position with two EU-GMP R&D and manufacturing sites (in Malta and Slovenia) supporting in-house drug development. These could potentially be monetised via contract manufacturing services. We expect the most significant upcoming catalysts to be the investigational new drug (IND) filings with the FDA for CannEpil and CimetrA, expected by end 2025 according to management.