IRLAB Therapeutics AB

Data from IRLAB’s Phase IIb study of mesdopetam has been published in Movement Disorders Clinical Practice. The publication in this prestigious, peer-reviewed medical journal further validates the integrity and clinical importance of the study results, which support the primary efficacy parameter and dose level selected for the upcoming Phase III program. “We are pleased that Movement Disorders Clinical Practice has accepted the publication of our Phase IIb data on mesdopetam. The results provide a strong foundation for the design of the upcoming Phase III program, where UDysRS will be used to evaluate mesdopetam at a daily dose of 7.5 mg twice daily.,” says Susanna Waters, Director of Systems Pharmacology at IRLAB. The data analyses showed clinically meaningful and dose-dependent anti-dyskinetic effects of mesdopetam, although the primary efficacy endpoint, good ON-time, was not met in this Phase IIb study. Several secondary evaluations for ON-phase dyskinesia, including the Unified Dyskinesia Rating Scale (UDysRS), showed clinically relevant and statistically significant improvement. Patients randomized to the highest dose, 7.5 mg twice daily, showed a high UDysRS response rate with 71.4% of the subjects achieving clinically relevant improvement. Furthermore, evaluation of OFF time showed a dose-dependent decrease, with the most substantial efficacy noted for the 7.5 mg dose, indicating that mesdopetam also may have antiparkinsonian efficacy. Overall, treatment with mesdopetam was safe and well tolerated, with an adverse event profile similar to placebo. Follow us for more updates on our pipeline in Parkinson's disease! #parkinsonsdisease  #irlabtherapeutics #drugdiscovery #innovation

The European Medicines Agency (EMA) has provided positive feedback on IRLAB's proposed design for the Phase III program of mesdopetam. Based on EMA’s guidance, IRLAB can now proceed with preparations for the registration studies of the drug candidate, which has demonstrated efficacy in a phase Ib and in two Phase II studies against levodopa-induced dyskinesia in patients with Parkinson’s disease. “With the positive feedback from EMA, we can now plan the design of the Phase III program for mesdopetam to meet regulatory requirements in both the U.S. and Europe. This significantly enhances the value of the project and is a crucial part in our discussions with potential collaborators for the final development stages and a possible commercialization of our unique drug candidate,” said IRLAB’s CEO, Kristina Torfgård. Following the successful dialogue with EMA and the company’s prior End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), IRLAB has reached a consensus with both European and US regulatory authorities on the remaining clinical development plan for mesdopetam. This agreement includes the program required for the approval of mesdopetam as a treatment for levodopa-induced dyskinesia (LIDs) in patients with Parkinson’s disease. #parkinsonsdisease  #irlabtherapeutics #drugdiscovery #innovation

The duration of IRLAB's existing loan from Fenja Capital of SEK 55 million has been extended from May 22, 2025, to June 30, 2026, at the latest. Additionally, the loan can be extended by an extra SEK 20 million under certain conditions. At the same time, IRLAB has raised new loans from some of its major shareholders for a total of SEK 22.4 million. This increases the company's financial resilience in a phase where several potentially value-creating milestones are rapidly approaching. “By extending the loan agreement with Fenja Capital and securing new loans from some of our major shareholders, we ensure the ability to maneuver and negotiate during a period where we see significant opportunities for value creation for our shareholders,” says IRLAB’s CFO, Viktor Siewertz. IRLAB continues to achieve significant progress across its extensive portfolio of drug projects, all of which have the potential to transform the treatment of Parkinson's disease. Partnership discussions are ongoing for the Phase III-ready drug project mesdopetam and pirepemat – a drug candidate being evaluated in a Phase IIb study with top-line results expected during the current quarter. The company's third clinical-stage project, IRL757, is fully funded through proof-of-concept studies under a research collaboration with MSRD/Otsuka. The recently announced liquidity boost is expected to enhance IRLAB's negotiating power in business discussions as well as the company's ability to maintain a rapid pace in the development of its drug projects.

A successful year with a focus on the future “Our pipeline is stronger than ever. We have presented our progress at several international conferences and investor meetings, where interest in our projects has been remarkably high. This reinforces my conviction that our drug candidates have the potential to become first-in-class treatments that can transform the lives of millions of people worldwide and their loved ones,” says Kristina Torfgård, CEO. Some highlights from the report: ✅ The company received USD 2.5 million in connection with the first dosing in a phase I study with IRL 757 in healthy older adults. ✅ All patients have completed the phase IIb study with pirepemat, REACT-PD. Topline data are expected in the first quarter of 2025. ✅ Positive results from the phase I studies support the continued development of IRL757. ✅ Payor research confirms significant market potential for mesdopetam in the US and europe. Read the full report here: https://lnkd.in/drsiTtj8 #parkinsonsdisease #irlabtherapeutics #drugdiscovery #innovation

The full-year report will be presented on Wednesday, February 12, 2025, at kl. 10.00 CET through a digital webcast. The presentation will be held in English, followed by a Q&A session. Access via link: https://lnkd.in/dxyr4nWf

The presentation will be held on February 12, 2025, at 10:00 CET via digital webcast. Kristina Torfgård, CEO, Nicholas Waters, EVP and Head of R&D, and Viktor Siewertz, CFO, will comment the year-end report. The presentation will be held in English and will be followed by a Q&A session. Follow the webcast online: https://lnkd.in/dxyr4nWf The year-end report and the presentation will be available on www.irlab.se, and the recorded version of the presentation will be available shortly afterward. Infront #parkinsonsdisease  #irlabtherapeutics #drugdiscovery #innovation

Du missade väl inte CFO Viktor Siewertzs presentation av IRLAB och bolagets portfölj inom Parkinsons sjukdom på Redeye Investor Forum den 30 januari? I så fall får du en ny chans via länken nedan: https://lnkd.in/dekRBNsv (IRLAB:s presentation startar 51 minuter in i sändningen) Redeye AB #parkinsonsdisease  #irlabtherapeutics #drugdiscovery #innovation

IRLAB today announces positive topline results from its Phase I clinical study with the drug candidate IRL757 in healthy adults aged 65 years and older. The results show that IRL757 is well absorbed and provides good exposure in the body. All participants completed the study, and no serious adverse events were recorded. Collectively, the safety, tolerability and pharmacokinetic profile supports further development of IRL757. "We are pleased to present these excellent topline results for IRL757 in healthy older adults. IRL757 is the first in a completely new class of drug candidates and is being developed to treat apathy – a very common but often overlooked symptom in neurodegenerative disorders. This condition impacts the quality of life of millions of elderly patients suffering from diseases, particularly those affected by Alzheimer's and Parkinson's," said Dr. Joakim Tedroff, MD, Chief Medical Officer, IRLAB. The Phase I study evaluated the pharmacokinetics, safety, and tolerability of ascending oral doses of IRL757 in healthy individuals aged 65 years and older. The findings confirm earlier results reported from the first part of the Phase I study, conducted in younger healthy participants. These results demonstrate that IRL757 is well absorbed and provides good systemic exposure without the occurrence of serious adverse events. This milestone marks the completion of the second clinical study with IRL757. It is also the first study conducted under the collaboration with the McQuade Center for Strategic Research and Development, LLC (MSRD), a member of the global Otsuka family of pharmaceutical companies. #parkinsonsdisease  #irlabtherapeutics #drugdiscovery #innovation

Den 27-28/1 gick Sahlgrenska Academy Junior Researcher Symposium av stapeln. IRLAB var på plats som sponsor och Karin Önnheim och Gaia Tolone passade på att mingla med morgondagens forskarkollegor och presentera bolagets ISP-plattform. 🚀 #parkinsonsdisease  #irlabtherapeutics #drugdiscovery #innovation Sahlgrenska Academy at University of Gothenburg Future Faculty Sahlgrenska

IRLAB meddelar idag att CFO Viktor Siewertz kommer att presentera IRLAB vid Redeye Investor Forum i Göteborg den 30 januari. Såväl svenska som internationella investerare deltar i mötet, vilket ger bolaget goda möjligheter att utvidga sitt nätverk och knyta nya kontakter. Evenemanget hålls på Pigalle, Södra Hamngatan 2A i Göteborg och presentationen kommer även att direktsändas via länken nedan och finnas tillgänglig i efterhand på Redeyes hemsida och sociala medier. Mer information om mötet: https://lnkd.in/dekRBNsv Redeye AB #parkinsonsdisease  #irlabtherapeutics #drugdiscovery #innovation