RL-007 / atai Life Sci - LARVOL DELTA

atai Life Sciences Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Corporate Highlights (GlobeNewswire) - "Recent Clinical Highlights and Upcoming Milestones:...RL-007: Pro-cognitive neuromodulator for cognitive impairment associated with schizophrenia (CIAS) (strategic investment in Recognify Life Sciences):...Recognify Life Sciences is running a Phase 2b proof-of-concept study in 234 patients living with CIAS. Topline results are expected in mid-2025."

P2b data • Trial status • Cognitive Disorders • Schizophrenia

A Study to Evaluate RL-007 in the Treatment of Cognitive Impairment Associated With Schizophrenia (CIAS) (clinicaltrials.gov) - P2 | N=234 | Recruiting | Sponsor: Recognify Life Sciences | Trial completion date: Nov 2024 ➔ Jul 2025 | Trial primary completion date: Jul 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Psychiatry • Schizophrenia

RL-007, a Novel Oral Neuromodulator Being Developed to Treat Cognitive Impairment Associated with Schizophrenia – a Non-Clinical and Clinical Overview (SIRS 2024) - "RL-007 enhances GABAergic signaling and hippocampal synaptic plasticity (long-term potentiation, LTP), via GABAB receptor dependent neuromodulation. RL-007 also acts synergistically with acetylcholine to enhance cholinergic signaling. RL-007 was found to be safe and well-tolerated, including in a CIAS population, and without typically observed GABAergic or cholinergic side effects."

Clinical • CNS Disorders • Schizophrenia

atai Life Sciences Reports Second Quarter 2023 Financial Results and Operational Highlights, and Announces Clinical Data from the Phase 1 Study of DMX-1002 (Ibogaine) (GlobeNewswire) - P1/2 | N=116 | NCT05029401 | Sponsor: DemeRx IB, Inc.| "atai Life Sciences...reported second quarter 2023 financial results and provided corporate updates...Today, the company announced results from the Phase 1 study of DMX-1002, a cholinergic, glutamatergic and monoaminergic receptor modulator being developed for the treatment of OUD...Results of the Phase 1 trial demonstrated that oral doses of DMX-1002 at 9 mg/kg achieved plasma concentrations in line with those described in previous studies in which subjects reported psychedelic experiences and obtained therapeutic benefit in OUD...The on-going Phase 2b study...of RL-007 vs placebo...The company expects to report topline results from this study in the 2nd half of 2024...on-going Phase 1 study...of VLS-01...The company expects to report additional clinical data in Q3 2023."

P1 data • P1/2 data • P2b data • Cognitive Disorders • Schizophrenia

A Study to Evaluate RL-007 in the Treatment of Cognitive Impairment Associated With Schizophrenia (CIAS) (clinicaltrials.gov) - P2 | N=234 | Recruiting | Sponsor: Recognify Life Sciences

New P2 trial • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Psychiatry • Schizophrenia

Safety, Biomarker Study of RL-007 in Subjects With Schizophrenia (clinicaltrials.gov) - P2 | N=37 | Completed | Sponsor: Recognify Life Sciences | Recruiting ➔ Completed

Trial completion • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Psychiatry • Schizophrenia

RL-007 Key Opinion Leader Event (BioSpace) - "Atai will host an event featuring a presentation by Richard S.E. Keefe, PhD...Dr Keefe will discuss the current treatment landscape and unmet medical need in treating patients with CIAS..."

Live event • Schizophrenia

Atai Life Sciences Announces Successful Outcome of Phase 2a Biomarker Trial of RL-007 in Cognitive Impairment Associated with Schizophrenia (BioSpace) - "Dr Keefe will discuss the current treatment landscape and unmet medical need in treating patients with CIAS..."

Biomarker • Schizophrenia

Safety, Biomarker Study of RL-007 in Subjects With Schizophrenia (clinicaltrials.gov) - P2; N=32; Recruiting; Sponsor: Recognify Life Sciences; Not yet recruiting ➔ Recruiting

Biomarker • Clinical • Enrollment open • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Psychiatry • Schizophrenia

atai Life Sciences Reports Second Quarter 2021 Financial Results and Business Update (GlobeNewswire) - "RL-007...atai is developing this compound for the treatment of cognitive impairments associated with schizophrenia....Topline results from the Phase 2a single-arm, multiple dose trial in patients with CIAS expected in late 2021."

P2a data • Schizophrenia

Recognify Life Sciences to Commence Phase 2a Study in Cognitive Impairment Associated with Schizophrenia (PRNewswire) - "Recognify Life Sciences, Inc. (Recognify)...today announced it has initiated a Phase 2a study for its lead compound RL-007, after receiving IND clearance from the Food and Drug Administration to commence clinical trials in the United States in this indication....This study will provide the first data sets for RL-007 in CIAS patients and enable Recognify to progress the product towards a Phase 2b efficacy study in this area of high medical need."

Trial status • Schizophrenia

Safety, Biomarker Study of RL-007 in Subjects With Schizophrenia (clinicaltrials.gov) - P2; N=32; Not yet recruiting; Sponsor: Recognify Life Sciences

New P2 trial • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Psychiatry • Schizophrenia