IRLAB Therapeutics

“The recent progress in the preparation for Phase III with mesdopetam strengthens our position in the ongoing discussions with potential partners. We continue to experience strong interest from various stakeholders and are now evaluating options in the further development and potential commercialization of our unique drug candidate, mesdopetam,” says IRLAB's CEO, Kristina Torfgård.

Positive feedback from regulatory authorities
IRLAB has recently held scientific advisory meetings with the German regulatory authority BfArM and its Portuguese counterpart INFARMED. In the meetings, both authorities provided clear guidance on, among other things, the critical components of the Phase III program, which are essentially in line with the plans agreed upon between IRLAB and the US Food and Drug Administration (FDA). As in the dialogues with the FDA, a consensus was reached on, among other things, the patient population, the primary and secondary endpoints, that the protocol follows regulatory guidelines of at least a 3-month treatment period, essential inclusion and exclusion criteria, the dose selection (7.5 mg twice daily), the number of participants in the program, as well as details on safety evaluation and documentation requirements.

The interactions with BfArM and INFARMED are part of the strategic regulatory activities, including the previously successful End-of-Phase 2 meeting with the FDA and the upcoming interaction with the European Medicines Agency (EMA). The aim is to ensure that the Phase III program and further development of mesdopetam are designed to meet the regulatory requirements in both the US and Europe.

New market research confirms the commercial potential
IRLAB has recently conducted in-depth market research to guide the company and its future commercial partners in positioning for a future launch of mesdopetam in the US and Europe. Structured interviews have been carried out with healthcare organization officials in both regions to better understand current treatment practices and the medical need for new treatments that can reduce levodopa-induced dyskinesias in Parkinson's disease. The results of the market research indicate a high willingness to pay for an anti-dyskinetic drug with a novel and effective mechanism of action. Thus, providing significant commercial potential for mesdopetam in both the US and Europe. It also shows that the planned design of the Phase III program aligns with the desires of the healthcare funders.

New meta-analysis highlights the medical benefits of mesdopetam
A meta-analysis recently presented at the International Congress of Movement Disorders (MDS) in Philadelphia, USA, shows that treatment with mesdopetam provides clinically meaningful anti-dyskinetic efficacy without causing impairment of motor function. Further, the drug candidate reduces “OFF time", the total time of the day when classic Parkinson's symptoms recur. The meta-analysis is based on two previously conducted Phase II studies with four and twelve weeks of treatment, respectively. The acknowledgment of the meta-analysis for presentation at such a prestigious international conference underscores its quality and the medical relevance of the results.