IRL757 reports positive Ph 1

IRLAB Therapeutics - Progress across the pipeline in Q324

IRLAB’s Q324 results highlighted progress across its clinical pipeline. Pirepemat cleared its final safety review and completed patient enrolment in the Phase IIb trial, making way for top-line readouts in Q125. IRL757 also made headway, reporting positive interim data from the first Phase I study and the initiation of a second study in older adults, triggering a US$2.5m (SEK26.6m) milestone payment from MSRD. Mesdopetam reported support from regulators in Germany and Portugal for the planned Ph...

Q3 report: Pirepemat on track to topline

Moving forward with mesdopetam

IRLAB Therapeutics - IRL757 progress prompts $2.5m milestone payment

IRLAB Therapeutics has announced that it will receive a $2.5m milestone payment from the McQuade Center for Strategic Research and Development (MSRD), prompted by the dosing of the first participant in a second Phase I trial for IRL757, which is being developed for apathy. The aim of this study is to assess the pharmacokinetics (PK), safety and tolerability of single ascending oral doses of IRL757 in healthy older adults (>65 years) and it is expected to conclude in late-Q424. The first Phase I ...

IRLAB Therapeutics - IRL757 starts strong in Phase I

IRLAB Therapeutics has announced an encouraging update for the ongoing Phase I trial for IRL757, which is being developed as a potential treatment for apathy. The single ascending dose (SAD) portion of the study has been successfully completed, with the initial data showing good absorption and exposure in the body, as well as a desirable safety and tolerability profile. The next step will be the multiple ascending dose (MAD) portion of the study, which management notes should be completed by end...

IRLAB Therapeutics - Pirepemat Phase IIb trial completes enrolment

IRLAB Therapeutics has announced the completion of patient enrolment for the Phase IIb trial (React PD) assessing pirepemat’s ability to improve balance and reduce falls in Parkinson’s disease patients (PD-Falls). The company also noted that a reduction in falls has been observed thus far in the patient population that has completed the treatment regimen, adding to the optimism about the potential outcome of the study. However, we caution that as this is a placebo-controlled, double-blind trial,...

Pirepemat Ph 2b study fully enrolled

IRLAB Therapeutics - New mesdopetam patent strengthens IP portfolio

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 debilitatin...

IRLAB Therapeutics - Anticipation builds as inflection points approach

IRLAB continued to progress its pipeline in Q224 and met key milestones, such as the clinical entry of IRL757 with non-dilutive backing from the Michael J Fox Foundation (MJFF) and the McQuade Center for Strategic Research and Development (MSRD). These partnerships provide external validation and de-risk the development plan (to proof of concept). After a supportive review from the independent data and safety monitoring board (DSMB), the pirepemat trial is on track to complete patient recruitmen...

Q2 report: IRL757 on the way

IRLAB Therapeutics - Pirepemat passes Phase IIb DSMB safety hurdle

IRLAB Therapeutics has successfully completed the second and final of two pre-determined safety and data integrity reviews for its ongoing Phase IIb clinical trial (React PD) for pirepemat. The study will assess the ability to improve balance and reduce falls in patients with Parkinson’s disease (PD-Falls). The independent data and safety monitoring board (DSMB) has unanimously recommended that the React PD study should continue without any changes. Hence, and in line with previous guidance, pat...

IRL757 brings new flavour

IRLAB has made important progress with its pipeline in the last six months. The lead programme mesdopetam passed the FDA end-of-Ph 2 meeting, paving the way for a pivotal Ph 3.

IRLAB Therapeutics - Mesdopetam disease-modifying potential

Researchers in China studying IRLAB’s lead asset, mesdopetam (IRL790) in a preclinical model for levodopa-induced dyskinesia in Parkinson’s disease (PD-LIDs) have noted that the treatment not only improved dyskinesia in the tested rodents but also potentially demonstrated neuroprotective (disease-modifying) properties by restoring or improving alterations in dendritic spine density in the implicated regions. We view the latter as a key observation, given that PD continues to be a progressive dis...

IRLAB Therapeutics - Valuation uplift supported by IRL757

IRLAB Therapeutics is swiftly progressing with the Phase I trial for IRL757, with the first participant recently dosed following regulatory approval earlier this month. IRL757 is being developed for the treatment of apathy, a common symptom in neurological conditions such as Parkinson’s disease (PD) and Alzheimer’s disease (AD), but with limited treatment options. The Phase I study will include two parts – with single and multiple ascending doses – which IRLAB plans to complete within CY24. The ...

IRLAB Therapeutics - External validation boosts quarterly recap

In its Q124 report, IRLAB recapped its efforts in targeting major aspects of Parkinson’s disease (PD). The update was enhanced by the recently announced R&D collaboration for IRL757, which is anticipated to fully fund all development activities through clinical proof-of-concept and support the advancement of the development programme through efficacy signal readouts in both PD and Alzheimer’s patient populations. IRLAB will take the compound into a Phase I study, funded by the MJFF, later this m...

Q1 report: building up IRL757

IRLAB Therapeutics - MSRD agreement early validation for IRL757

The McQuade Center for Strategic Research and Development (MSRD) has signed an exclusive R&D collaboration for IRLAB’s preclinical candidate IRL757, following recent clearance by Swedish authorities to start clinical trials. This positive development provides early validation of IRLAB’s preclinical pipeline, in our view, and potential upside to our valuation provided there is clinical progress. Under the collaboration, MSRD will fund IRL757’s clinical development to proof-of-concept (PoC) in add...

IRL757 Ph 1 ready to start

IRLAB Therapeutics - Beyond PD-LID, a closer look at PD-psychosis

While IRLAB Therapeutics’ immediate focus is on advancing mesdopetam in levodopa-induced dyskinesia (PD-LID) following the recent green light from the FDA for its Phase III trial design, we expect the Parkinson’s disease-psychosis (PD-P) programme to be revived as the lead programme progresses towards commercialisation. We continue to see label expansion opportunities in this indication for IRLAB as we model a 2032 PD-P launch with a 20% probability of success (PoS). PD-P is a common occurrence,...