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 pre-clinical candidate IRL757, following recent clearance by Swedish authorities to start clinical trials. This positive development provides early validation of IRLAB’s pre-clinical 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 a...

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,...

IRLAB Therapeutics - FDA thumbs up to mesdopetam’s Phase III plan

IRLAB Therapeutics has confirmed the FDA’s alignment with its proposed Phase III programme for mesdopetam in levodopa-induced dyskinesias (PD-LIDs), following receipt of the minutes from its end-of-Phase II (EoP2) meeting held last month. Notably, the FDA has agreed on the primary endpoint being the Unified Dyskinesia Rating Scale (UDysRS), on which mesdopetam demonstrated a statistically significant improvement (p=0.026) in the Phase IIb study (secondary endpoint of that study). IRLAB will now ...

IRLAB Therapeutics - Mesdopetam’s potential highlighted in PD-psychosi...

The recent scientific paper in Neurotherapeutics discusses the encouraging preclinical studies focused on the characterisation of the neurophysiological brain state in Parkinson’s disease psychosis (PD-Psychosis), a target indication of IRLAB’s lead asset, mesdopetam. While IRLAB’s clinical programme for this candidate in PD-Psychosis is currently on hold (Phase II-ready at present), the antipsychotic efficacy demonstrated in this preclinical research seems to support the case for further clinic...

IRLAB Therapeutics - Positive FDA mesdopetam outlook following EoP2

IRLAB Therapeutics reported positive feedback from its FDA end-of-Phase II (EoP2) meeting earlier in the week for mesdopetam. According to management, the meeting was held in a constructive and engaging spirit, and discussions during the meeting suggested alignment between the company and the regulatory authority on the design of a Phase III programme for mesdopetam as a potential treatment for levodopa-induced dyskinesias (PD-LIDs). In our view, this update is a positive sign for further clinic...

IRLAB Therapeutics - Timeline refresh with numerous inflection points

IRLAB has reported FY23 results and provided operational and regulatory updates, including an end-of-Phase II (EoP2) meeting with the FDA for mesdopetam and extended patent protection for pirepemat to at least 2038. Management continues to progress its preclinical assets, including IRL757 (Phase I ready, with clinical entry expected in Q224 with support from the Michael J Fox Foundation, MJFF), as well as IRL942 and IRL1117 (both expected to be Phase I ready by end 2024). The SEK111.3m cash posi...

IRLAB Therapeutics - End-of-Phase II FDA meeting set

IRLAB Therapeutics has scheduled an end-of-Phase II (EoP2) meeting (on 20 February 2024) with the US FDA for the mesdopetam programme. This marks an important milestone for IRLAB as it will evaluate the clinical data generated to date and aim to reach a conclusion for the design of the planned Phase III programme. The meeting should also outline a clear path to a possible new drug application (NDA), including if any other information is required to support an NDA submission. Management will anno...

IRLAB Therapeutics - SEK55m loan enhances headroom past key catalysts

IRLAB Therapeutics has announced a new loan facility of up to SEK55m with Formue Nord to support its development programmes. Provided the facility is fully drawn down, we estimate it will extend IRLAB’s cash runway through Q324, past key inflection points (top-line results from the pirepemat Phase IIb trial and the results from the end of Phase II meeting with the FDA, both expected in H124). Considering the market environment, we view the transaction as practical as it provides increased liquid...

IRLAB Therapeutics - IRL757 Phase I-ready with support from MJFF

IRLAB Therapeutics has announced that IRL757, a drug candidate being developed for the treatment of apathy in Parkinson’s disease (PD) and other neurological conditions, is now Phase I-ready. Management is preparing the required documentation to submit a Phase I clinical trial application for regulatory approval, on track with the company’s previously disclosed guided timelines. The company has also reported that it has entered into a grant agreement with the Michael J. Fox Foundation (MJFF) for...

IRLAB Therapeutics - Mesdopetam’s clinical roadmap laid out

IRLAB has submitted a request for an end-of-Phase II meeting (EoP2) with the FDA for its lead asset, mesdopetam, to chart the Phase III roadmap for the drug. According to FDA guidelines, the agency intends to respond to such requests within 14 days and schedule a meeting within 70 calendar days from the receipt of the request. We see the EoP2 meeting as an important inflection point for IRLAB to continue clinical development of mesdopetam after securing full ownership rights from Ipsen in August...

IRLAB Therapeutics - Increased legroom for pirepemat with new patent

IRLAB has been granted a new patent for its Phase IIb asset, pirepemat, extending the predicted patent life of the drug to 2038 (previous composition of matter patents would have expired by 2035). This patent covers a new salt of the active pharmaceutical ingredient, as well as the process for its preparation, and applies to the important markets of Europe, Japan and China. Pirepemat is a key drug in the company’s pipeline, which targets postural dysfunction (impaired balance) and falls in Parki...

IRLAB Therapeutics - Quarterly update recapping active pipeline plans

Management presented its quarterly earnings, adding context to the recent capital markets day (CMD), highlighting IRLAB’s strategic focus on continuing with further development of mesdopetam after securing full rights from Ipsen (in August). As a reminder, management shared detailed analysis of the Phase IIb trial in August 2023, which indicated statistically significant secondary endpoints. All eyes are now on the end-of-Phase II (EoP2) meeting with the FDA (possibly in H124) which, if favourab...

IRLAB Therapeutics - Collaboration to support FDA Ph III progression

IRLAB is collaborating with two US-based advisory groups, Clintrex (clinical research company) and ProPharma Group (research consulting organisation) for expert guidance in preparing a brief package for mesdopetam to request an end-of-Phase II meeting with the US FDA. This development comes after the detailed analysis of Phase IIb trial data in August 2023, which confirmed the safety and tolerability of mesdopetam and indicated dose-dependent anti-dyskinetic and anti-Parkinsonian effects. We awa...

IRLAB Therapeutics - Numerous clinical platform activities under way

IRLAB has reported its Q223 results, including a recap of clinical activities and financials. IRLAB shared a full analysis of the mesdopetam Phase IIb trial data, and noted the company’s focus on preparing for its FDA end-of-Phase II meeting after securing full rights to the project (previously out-licensed to Ipsen). In addition to the FDA preparations, IRLAB will maintain a flurry of clinical activity, including the anticipated release of top-line results for the Phase IIb pirepemat trial (H12...

IRLAB Therapeutics - Despite shift, mesdopetam still on track for Ph I...

IRLAB has secured full global rights ownership of mesdopetam, the company’s leading asset, which was previously out-licensed to Ipsen. All preclinical studies and Phase I, Ib, IIa and IIb trials were completed as part of this collaboration. Full ownership, including associated intangibles and materials, will return to IRLAB in exchange for future (low single-digit) royalties on future product sales. With Ipsen’s support, IRLAB is preparing for an end of Phase II meeting with the FDA, which we vi...

IRLAB Therapeutics - Phase IIb pirepemat obtains safety milestone

IRLAB Therapeutics has provided an update on its ongoing Phase IIb clinical trial for pirepemat, which has been designed to improve balance and reduce falls in patients with Parkinson’s disease (PD-Falls). The independent data and safety monitoring board (DSMB) for the study has unanimously recommended that the trial should continue without any modifications, after it reviewed the safety and integrity of the data from the initial 25 participants completing the study. Management expects patient r...

IRLAB Therapeutics - On track for pirepemat in Phase IIb

IRLAB has announced that it has activated all 38 sites in the ongoing Phase IIb pirepemat trial. This study is assessing pirepemat as a potential treatment to improve balance and reduce falls in patients with Parkinson’s disease (PD). It is a randomised, double-blind, placebo-controlled study aiming to recruit 165 patients across six European countries. We believe this update is a positive sign that the trial is progressing as anticipated. Management has communicated that patient recruitment is ...

IRLAB Therapeutics - Collaboration bolsters CNS assets and platform

IRLAB has announced an agreement with the McQuade Center for Strategic Research and Development (MSRD), a member of the Otsuka family of pharmaceutical companies. As part of this agreement, MSRD will evaluate IRLAB’s neuropsychiatric preclinical programmes: IRL757 (apathy) and IRL942 (cognitive function). MSRD searches for, identifies and funds innovative early-stage R&D programmes that it believes have the potential to build the future portfolio of Otsuka products. We view this external interes...