IRLAB Therapeutics - Pirepemat fails Ph 2b REACT-PD

• 42% decrease of fall rate with pirepemat...
• ...but no stat. significance vs. placebo group
• Analyses ongoing, but very likely the end for pirepemat

Pirepemat does not reduce falls vs. placebo

Today IRLAB reported the topline results of the Ph 2b REACT-PD study testing pirepemat to reduce falls in patients with Parkinson's disase. While the 600 mg arm of the study (high dose group) showed a reduction in fall rate by 42%, the difference to the placebo group (no numerical value shared) was not statistically significant. 146 patients were screened, whereof 104 were randomized and only 90 completed the 12w treatment period. IRLAB communicated that an improvement in cognitive impairment (MoCA) was observed, but it did not reach stat. significance either. Adverse events were at 70% across all three study arms (two active, one placebo). As a reminder, the study tested daily 600 mg pirepemat vs. 300 mg pirepemat vs. placebo.

Next: in-depth analyses of the dataset

Next, IRLAB will conduct in-depth analyses to understand why the study failed on the primary endpoint of the reduction of falls. IRLAB's CMO Joakim Tedroff commented that the placebo fall rate was higher than in any previous study in the field.

The end for pirepemat, all-in on early assets is the way forward

We believe that this will be the end of the road for pirepemat and IRLAB will eventually discontinue the drug's development. The pirepemat results will negatively affect the prospects to strike a licensing deal for mesdopetam. As a reminder, mesdopetam's Ph 2b also failed on the primary endpoint, after which Ipsen returned the rights to IRLAB (both in 2023). Since then, IRLAB is looking for a partnership to advance the project into Ph 3 based on positive data from an alternative endpoint. In our view, IRLAB will need to find a new set-up for the company in the months to come (likely cost cuts) and refocus the company on the early-stage assets IRL757, 1177 and 942. IRLAB's loans (Fenja Capital and shareholder loan, SEK 55+22m) mature at YE'25. The potential IRL757-related MSRD milestone payments this year will not be sufficient to cover the loans, therefore the company will need to find a new solution, either sign an expanded IRL757 deal or strike new licence agreements for one or several of their other early stage assets (IRL1177/942). We expect more colour at the conf call today at 15:30 CET (link).