IRL757 / IRLAB Therap - LARVOL DELTA

IRLAB Therapeutics AB…announced that its collaborator, - the McQuade Center for Strategic Research and Development, LLC (MSRD) - has issued a payment of USD 4 million to further advance the drug candidate IRL757 into a clinical safety, tolerability and Signal Finding Study in patients with Parkinson's disease who experience apathy. (ACCESS Newswire) - "The first patients are expected to be enrolled before the end of 2025."

Financing • New P1 trial • Parkinson's Disease

IRLAB reports positive results from the second part of a Phase I study with IRL757 (Irlab Therapeutics) - P1 | N=82 | NCT06493045 | "IRLAB Therapeutics...announces the company has successfully completed the second and final part of its clinical Phase I study, in which the drug candidate IRL757, being developed for the treatment of apathy, was administered in multiple ascending doses (MAD). The results show that IRL757 is well absorbed and provides good exposure in the body following ten days of dosing. All participants completed the study, and no serious adverse events were recorded. The safety, tolerability and pharmacokinetic profile of IRL757 support continued clinical development....Based on the positive results from the completed Phase I studies, a clinical Phase Ib study in Parkinson's disease and apathy has been initiated in cooperation with The McQuade Center for Strategic Research and Development (MSRD), a member of the global Otsuka family of pharmaceutical companies. The first patients are expected to be enrolled in the study in the second half of 2025."

P1 data • Trial status • Parkinson's Disease

IRL757C001 – A FIRST-IN-HUMAN TRIAL ON IRL757, A CORTICAL ENHANCER IN CLINICAL DEVELOPMENT FOR THE TREATMENT OF APATHY IN AD/PD (ADPD 2025) - "We present data from the firs t-in-human trial of IRL757 a cortical enhancer in development for treatment of apathy associated with AD and PD. Preliminary results showed that IRL757 is safe and well tolerated over a wide dose range upon single dosing to healthy volunteers. Detailed PK and safety data will be presented at the meeting."

Clinical • P1 data • Alzheimer's Disease • CNS Disorders • Movement Disorders • Parkinson's Disease

CORTICAL ENHANCEMENT - A NEW TREATMENT STRATEGY FOR SYMPTOMATIC TREATMENT AND SLOWING OF DISEASE PROGRESSION IN AD AND PD (ADPD 2025) - "Results Three cortical enhancer candidates have been selected and brought into clinical development: Pirepemat (IRL752), currently Phase 2b for prevention of falls in PD; IRL757, targeting PD-apathy, currently Phase 1 supported by MJFF; IRL942, targeting cognitive impairment, IND-enabling studies ongoing...Sustaining cortical neuronal activity may help maintain neuronal integrity and synaptic strength in connected subcortical areas, hence providing resilience from neurodegeneration. By directly strengthening cortico-subcortical circuitries, symptomatic effects including cognitive impairment, apathy, and falls could also be achieved."

Alzheimer's Disease • CNS Disorders • Cognitive Disorders

IRLAB to Present Clinical and Preclinical Data at the AD/PD(TM) 2025: 19th International Conference on Alzheimer’s & Parkinson’s Diseases (Yahoo Finance) - "IRLAB Therapeutics...announced that it will showcase three abstracts at the AD/PD 2025: 19th International Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders, taking place in Vienna, Austria, April 1-5, 2025."

Clinical data • Alzheimer's Disease • Parkinson's Disease

First-In-Human (FIH) Trial Evaluating the Safety and Tolerability of Single and Multiple Ascending Oral Doses of IRL757 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=82 | Completed | Sponsor: Integrative Research Laboratories AB | Recruiting ➔ Completed

Trial completion

IRLAB reports positive topline results from Phase I study with IRL757 in healthy older adults (Irlab Therapeutics) - P1 | N=12 | NCT06699628 | Sponsor: Integrative Research Laboratories AB | "The results show that IRL757 is well absorbed and provides good exposure in the body. All participants completed the study, and no serious adverse events were recorded...The Phase I study evaluated the pharmacokinetics, safety, and tolerability of ascending oral doses of IRL757 in healthy individuals aged 65 years and older. The findings confirm earlier results reported from the first part of the Phase I study, conducted in younger healthy participants. These results demonstrate that IRL757 is well absorbed and provides good systemic exposure without the occurrence of serious adverse events. This milestone marks the completion of the second clinical study with IRL757."

P1 data • CNS Disorders • Parkinson's Disease

Phase I Trial Evaluating the Pharmacokinetics of Single Ascending Oral Doses of IRL757 in Healthy Elderly Volunteers (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Integrative Research Laboratories AB

New P1 trial

Positive Data from the First Part of IRLAB's Phase I Study with the Drug Candidate IRL757 (ACCESSWIRE) - P1 | N=82 | NCT06493045 | Sponsor: Integrative Research Laboratories AB | "IRLAB Therapeutics...today announces that the company has successfully completed the first part of its Phase I clinical trial with single ascending doses (SAD) of the drug candidate IRL757, which is being developed for the treatment of apathy. The results show that IRL757 is well absorbed, provides good exposure in the body and has a good tolerability and safety profile...IRLAB will now proceed with the second part of the study, in which the study participants will receive multiple ascending doses (MAD)...The study is expected to be fully completed by the end of 2024 and top-line results are expected to be presented in the first quarter of 2025."

P1 data • Trial completion date • CNS Disorders • Parkinson's Disease

First-In-Human (FIH) Trial Evaluating the Safety and Tolerability of Single and Multiple Ascending Oral Doses of IRL757 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=82 | Recruiting | Sponsor: Integrative Research Laboratories AB

New P1 trial

IRLAB has Administered the First Dose in a Phase I Clinical Trial with the Drug Candidate IRL757 (ACCESSWIRE) - "IRLAB Therapeutics AB...announced that dosing has been initiated in a Phase I study of the drug candidate IRL757....The Phase I study consists of two parts and aims to document the safety, tolerability, and pharmacokinetic properties of IRL757 in healthy subjects. In the first part, ascending doses of the drug candidate are administered (Single Ascending Dose, SAD), and in the second part, repeated and ascending doses are given (Multiple Ascending Dose, MAD). In addition, the possible influence of concomitant food intake will be documented. The study is expected to be fully completed in 2024."

Trial status • Parkinson's Disease

IRLAB Enters a Development Collaboration for IRL757 as a Novel Treatment for Apathy (Irlab Therapeutics) - "IRLAB Therapeutics AB...today announced a collaboration agreement between IRLAB and the McQuade Center for Strategic Research and Development, LLC (MSRD)...IRLAB and MSRD will exclusively collaborate in the development of IRLAB’s novel drug candidate IRL757...IRLAB is currently initiating the first-in-man Phase I program with IRL757, funded by The Michael J. Fox Foundation, with anticipated recruitment starting in Q2, 2024....Under the current collaboration, IRLAB is eligible to receive 3 million USD in up-front payment and up to an additional 5.5 million USD following the achievement of certain development milestones."

Enrollment status • Licensing / partnership • CNS Disorders • Parkinson's Disease

IRLAB has Received Approval from the Swedish Medical Products Agency to Conduct a Phase I Study of the Drug Candidate IRL757 (ACCESSWIRE) - "IRLAB Therapeutics AB...announced that the Swedish Medical Products Agency has approved the initiation of a Phase I clinical study of the drug candidate IRL757. IRL757 is being developed as a treatment to counteract apathy - a condition that impairs the quality of life for millions of people with Parkinson's disease, Alzheimer's disease and other CNS diseases....The Phase I study consists of two parts and aims to document the safety, tolerability and pharmacokinetic properties of IRL757 in healthy subjects. In the first part of the study, single ascending doses of the drug candidate are administered (SAD) whereas the second part covers multiple ascending doses (MAD). In addition, the possible influence of concomitant food intake will be documented. The study is expected to be fully completed by the end of 2024 and top line results are expected to be presented in the first quarter of 2025."

New P1 trial • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

IRLAB’s Drug Candidate IRL757 is Phase I Ready (Yahoo Finance) - "IRLAB Therapeutics AB...today announced that the company's drug candidate IRL757, has completed all preclinical studies and development work necessary to start Phase I. All documentation is currently being prepared in a Phase I clinical trial application to be submitted for regulatory approval."

Preclinical • CNS Disorders • Parkinson's Disease

IRLAB Therapeutics and the McQuade Center for Strategic Research and Development Enter into Agreement to Evaluate IRLAB’s Neuropsychiatric Programs IRL757 and IRL942 (BioSpace) - "IRLAB Therapeutics...IRLAB Therapeutics AB...today announced the signing of an agreement, with the McQuade Center for Strategic Research and Development, LLC (MSRD) (a member of the global Otsuka family of pharmaceutical companies), for MSRD to evaluate the neuropsychiatric compounds IRL757 and IRL942 under exclusivity. MSRD, which identifies and supports early-stage opportunities that can change the landscape of treatments for mental illness and renal disorders, will exclusively evaluate and scientifically review the compounds, in exchange for providing IRLAB with an upfront payment. MSRD and IRLAB may, after the evaluation, agree to expand activities into a collaboration to continue to develop the compounds as pharmaceutical products."

Licensing / partnership • CNS Disorders • Parkinson's Disease

IRLAB updates on portfolio development milestones (Market Screener) - "IRLAB Therapeutics AB...today announced that the company has assessed the operational priorities for 2023....This will not impact the priority of the ongoing Phase IIb study of pirepemat in PD-Falls. The preclinical programs will proceed according to their respective plans; IRL757 will proceed to be Phase I ready by year-end 2023, IRL942 will be Phase I ready in H1 2024 and P003 candidate IRL1117 is just initiating its preclinical program with in-house R&D activities during 2023. The analysis of the completed Phase IIb study of mesdopetam continues, and it is anticipated that further data will be presented during H1 2023. The ongoing Phase IIb study of pirepemat...is active and progressing to plan with 28 of 39 planned sites in five European countries. Patient recruitment is slower than anticipated, and actions are ongoing to address this. The updated estimates predict the study will be fully recruited by the year-end 2023 with top-line results in H1 2024."

Enrollment status • New P1 trial • P2b data • Preclinical • CNS Disorders • Cognitive Disorders • Parkinson's Disease

IN VIVO SYSTEMS RESPONSE PROFILE MAPPING OF NOVEL CANDIDATE DRUGS IN DEVELOPMENT FOR TREATMENT OF SYMPTOMS RELATED TO CORTICAL IMPAIRMENT IN PARKINSON'S DISEASE (ADPD 2023) - " Treatment response profiles were generated for CNS reference compound s, including PD drugs, antidepressants, antipsychotics, psychostimulants, procognitive drugs, and candidate drugs IRL942, IRL757 and Phase IIb compound pirepemat. Systems response profiling/mapping of new candidate drugs suggest a pharmacological differentiation, IRL942 displaying a predominantly procognitive profile, IRL757 expressing additional effects suggesting effects also on symptoms linked to the underlying subcortical degeneration in PD, such as apathy, warranting clinical evaluation. This new class of compounds may have broad utility in neurocognitive disorders."

Preclinical • CNS Disorders • Cognitive Disorders • Developmental Disorders • Movement Disorders • Parkinson's Disease