IRLAB Therapeutics AB

Missade du VD Kristina Torfgårds presentation av IRLAB och bolagets portfölj inom Parkinsons sjukdom på Stora Aktiedagarna den 11 mars? 🚀 I så fall får du en ny chans via länken här: https://lnkd.in/dA7vSSxQ Aktiespararna #parkinsonsdisease  #irlabtherapeutics #drugdiscovery #innovation

 IRLAB today announced that preclinical data on mesdopetam have been published in the prestigious, peer-reviewed medical journal European Journal of Neuroscience, EJN. The data provide new insights into the system-level mechanisms behind the antidyskinetic effect of mesdopetam and suggest potential additional benefits in the treatment of Parkinson’ s-related psychosis. Levodopa, the standard treatment for Parkinson’s disease, provides effective relief from symptoms. However, it often does not sufficiently address non-motor symptoms, and long-term use may lead to motor fluctuations and dyskinesia.   The recent study examines the effects of IRLAB’s drug candidate mesdopetam, amantadine, and pimavanserin in a preclinical model of levodopa-induced dyskinesia. It explores the mechanisms of levodopa-induced dyskinesia and the associated pharmacological strategies to alleviate dyskinetic symptoms.   The study shows that reducing a specific type of brain activity, narrow gamma band oscillations (NBGs), especially in the sensorimotor areas, correlates with decreased dyskinesias for both amantadine and mesdopetam. The findings suggest that diminishing NBGs is an essential biomarker for assessing the effects of antidyskinetic treatments. Additionally, the data offer insights into the systems-level mechanisms behind the antidyskinetic effectiveness of mesdopetam and suggest potential additional benefits for the treatment of Parkinson-related psychosis.   “This is a comprehensive series of studies enabling in-depth comparisons of the compounds. The results clearly illustrate the differences in effect profiles and action mechanisms, favoring mesdopetam as a treatment for dyskinesia,” says Nicholas Waters, EVP and Head of R&D at IRLAB.   The paper reports preclinical work performed by the Department of Medical Translational Biology, Umeå University, Sweden, and Integrative Neurophysiology, Lund University, Sweden, in collaboration with scientists at IRLAB.   The article Neurophysiological treatment effects of mesdopetam, pimavanserin, and amantadine in a rodent model of levodopa-induced dyskinesia was written by N Abdolaziz R et al. and can be read in full here: https://lnkd.in/d-tWf9Xt   #parkinsonsdisease  #irlabtherapeutics #drugdiscovery #innovation

IRLAB announces topline results from the Phase IIb study of pirepemat (REACT-PD). The results show that treatment with pirepemat (600 mg daily) reduced the fall rate by 42 percent among individuals with Parkinson's disease; however, this effect did not reach statistical significance compared to placebo. The company will now conduct in-depth analyses of the study data ahead of a decision on the further development strategy for the drug candidate. “The results of the Phase IIb study with pirepemat will delay our efforts to provide a treatment that reduces the frequency of falls in individuals with Parkinson's disease. Extensive further analytical work will now be conducted before we can determine the project's future direction. We remain convinced that our drug candidates have the potential to enhance the quality of life for patients and their families while helping to lower healthcare costs. Alongside the ongoing analysis of study data from the Phase IIb study of pirepemat, we are focusing on the Phase III-ready project mesdopetam, the Phase I project IRL757, and the drug candidate IRL1177 which has the potential to replace the current standard treatment for Parkinson's disease, and IRL942," says IRLAB's CEO, Kristina Torfgård. In the Phase IIb study, 146 patients were screened, 104 were randomized, and 90 completed the 12-week treatment period. The primary endpoint was the change in patients' fall rates during the treatment period. The fall rate decreased by 42 per cent for those treated with pirepemat at a daily dose of 600 mg, but the effect did not reach statistical significance compared to placebo. The results of the cognitive scale used in the study (Montreal Cognitive Assessment, MoCA) indicated a meaningful improvement in cognitive impairment for patients treated with pirepemat (600 mg daily). However, this effect did not reach statistical significance. The adverse event profile was consistent with previously reported clinical trial results for pirepemat. Adverse events were reported by approximately 70 percent of study participants, evenly distributed among the three treatment groups. During the study, one death was reported for a participant receiving placebo. #parkinsonsdisease  #irlabtherapeutics #drugdiscovery #innovation

Missa inte CFO Viktor Siewertzs presentation från Life Science-dagen 2025 där han presenterar IRLAB:s pipeline inom Parkinsons sjukdom och berättar om bolaget senaste framsteg. https://lnkd.in/dsSqpQ9F #parkinsonsdisease  #irlabtherapeutics #drugdiscovery #innovation Finwire Media

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