ALX-001 / Allyx Therap, BMS - LARVOL DELTA

ALX-923-108: A Study Evaluating the Potential of BMS-984923 to Alter the Systemic Exposure of Three Orally Administered Probe Substrates (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Allyx Therapeutics | Trial completion date: Mar 2025 ➔ Oct 2025 | Trial primary completion date: Jan 2025 ➔ Apr 2025

Trial completion date • Trial primary completion date

ALX-923-108: A Study Evaluating the Potential of BMS-984923 to Alter the Systemic Exposure of Three Orally Administered Probe Substrates (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Allyx Therapeutics | Not yet recruiting ➔ Active, not recruiting

Enrollment closed

Allyx Therapeutics Awarded $3.3 Million NIH Grant to Support Further Clinical Studies of Lead Candidate ALX-001 (GlobeNewswire) - "Allyx Therapeutics announced today that it has been awarded a $3.3 million grant from the National Institutes of Health as part of its Small Business Innovation Research Commercial Readiness Pilot program. This funding will support further investigation of Allyx’s lead clinical asset, ALX-001...Allyx intends to utilize the Commercial Readiness Pilot funding to support a Phase I clinical pharmacokinetic drug-drug interaction study (NCT06632990) to determine the impact of multiple doses of ALX-001 on various cytochrome P450 enzymes."

Financing • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

Aging-dependent loss of functional connectivity in a mouse model of Alzheimer's disease and reversal by mGluR5 modulator. (PubMed, Mol Psychiatry) - "In a second cohort of 20-month-old mice with persistent functional connectivity deficits for AD relative to WT, we assess the impact of two-months of oral treatment with a silent allosteric modulator of mGluR5 (BMS-984923/ALX001) known to rescue synaptic density. Functional connectivity deficits in the aged AD mice are reversed by the mGluR5-directed treatment. The longitudinal application of fMRI has enabled us to define the preclinical time trajectory of AD-related changes in functional connectivity, and to demonstrate a translatable metric for monitoring disease emergence, progression, and response to synapse-rescuing treatment."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders

A Study Evaluating the Potential of BMS-984923 to Alter the Systemic Exposure of Three Orally Administered Probe Substrates (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Allyx Therapeutics

New P1 trial

Allyx Therapeutics Announces First Parkinson’s Disease Patient Treated with ALX-001 (GlobeNewswire) - "Allyx Therapeutics has announced that the first patient has been dosed with its lead compound, ALX-001, in a new clinical study assessing safety, pharmacokinetics and potential therapeutic response in patients with Parkinson’s disease."

Trial status • CNS Disorders • Parkinson's Disease

A Multiple Ascending Dose Study in Healthy Volunteers and Patients With Alzheimer's Disease (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Allyx Therapeutics | Trial completion date: Jul 2024 ➔ Jul 2025 | Trial primary completion date: Jul 2024 ➔ Jul 2025

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

Food Effect Study of BMS-984923 in Healthy Older Adult Volunteers (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Allyx Therapeutics | Trial completion date: Jun 2024 ➔ Nov 2024

Trial completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Allyx Therapeutics Announces First Alzheimer’s Disease Patient Treated with Lead Compound ALX-001 (GlobeNewswire) - "Allyx Therapeutics...announced that the first Alzheimer’s disease patient has been dosed with its lead compound, ALX-001, in a clinical study....Individuals with Alzheimer’s disease are being enrolled in a 28-day study which will evaluate the safety of ALX-001 dosed twice daily at either 50 mg or 100 mg versus placebo in adults between 50 and 80 years of age. This is the second phase of an ongoing study which previously assessed multiple ascending doses in healthy volunteers (NCT05804383) and is being conducted at Yale School of Medicine with support from the National Institute on Aging."

Trial status • Alzheimer's Disease

ALX-923-107: A Study to Assess the Safety of BMS-984923 Compared to Placebo, in People With Parkinson's (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Allyx Therapeutics

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

ALX-923-107: A Study to Assess the Safety of BMS-984923 Compared to Placebo, in People With Parkinson's (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Allyx Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

Allyx Therapeutics Announces Expansion into Parkinson’s Disease Clinical Research with Lead Compound ALX-001 Following IND Acceptance (GlobeNewswire) - "Allyx Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND), enabling the company to proceed with clinical research in Parkinson’s disease. A 28-day safety study of ALX-001 in Parkinson’s disease patients will be initiated in Q1 2024....Results from the recently-completed Phase 1b multiple ascending dose study will be presented in March at the AD/PD™ 2024 Conference in Lisbon."

IND • New trial • P1 data • Alzheimer's Disease • CNS Disorders

A PHASE 1B MULTIPLE ASCENDING DOSE STUDY OF THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF ALX-001, AN MGLUR5 SILENT ALLOSTERIC MODULATOR, IN HEALTHY OLDER ADULTS. (ADPD 2024) - "ALX-001 is safe and well tolerated for 20-days with twice daily oral dosing. Plasma exposures reached levels achieve full coverage of the IC80 for receptor occupancy at trough which is expected to yield therapeutic benefit in patients. Further studies are planned to assess the safety, tolerability, and potential efficacy of ALX-001 in patients with AD and PD."

Clinical • P1 data • PK/PD data • CNS Disorders • PRNP

NeuroVoices: Adam Mecca, MD, PhD, on mGlurR5 Modulator ALX-001 as Potential Treatment for Alzheimer Disease (NeurologyLive) - "The drug's mechanism is based on preclinical work done by Stephen Strittmatter, MD, PhD, AB, at Yale. It focuses on the metabotropic glutamate receptor subtype (mGluR5). In normal situations, it's thought to regulate synapses through calcium regulation. However, in Alzheimer's disease models, amyloid beta oligomers exert a pathologic signaling through mGluR5."

A Multiple Ascending Dose Study in Healthy Volunteers and Patients With Alzheimer's Disease (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Allyx Therapeutics | Trial completion date: Nov 2024 ➔ Jul 2024

Trial completion date • Alzheimer's Disease • CNS Disorders

A Multiple Ascending Dose Study in Healthy Volunteers and Patients With Alzheimer's Disease (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Allyx Therapeutics | Phase classification: P1b ➔ P1 | Trial primary completion date: Oct 2024 ➔ Jul 2024

Phase classification • Trial primary completion date • Alzheimer's Disease • CNS Disorders

A phase 1a single ascending dose study of the safety, tolerability, and brain receptor occupancy of BMS-984923 in healthy older adults (CTAD 2023) - P1 | "BMS-984923 is safe and tolerable at single doses high enough to achieve significant target engagement, supporting continued development for the treatment of AD. Further studies are planned to assess the safety and tolerability of multiple doses of BMS-984923 in healthy older adults and patients with AD. . gov."

Clinical • P1 data • Alzheimer's Disease • Cardiovascular • CNS Disorders • Hypertension • Pain • PRNP

Allyx Therapeutics Lead Compound ALX-001 is Safe and Tolerable at Doses, Achieving Full Brain Target Engagement in Healthy Older Adults (GlobeNewswire) - P1 | N=36 | NCT04805983 | "The study showed that all doses of ALX-001 were well tolerated, up to and including levels high enough to achieve full brain target engagement, supporting the company’s plans to continue clinical development for the treatment of Alzheimer’s disease....Safety findings were also encouraging. All doses of ALX-001 were well-tolerated and there were no serious adverse events....Clinical research of ALX-001 in Alzheimer’s disease is advancing, with a Phase 1 multiple ascending dose study in healthy volunteers expected to finish in Q4 2023."

P1 data • Trial status • Alzheimer's Disease • CNS Disorders

Allyx Therapeutics to Present Phase 1 Data for Lead Compound ALX-001 at the 16th Clinical Trials on Alzheimer's Disease Meeting (Yahoo Finance) - "'Our quest for meaningul, disease-modifying therapies for people living with Alzheimer's disease continues as we pursue this novel approach which targets neurons and acts independently of amyloid beta removal,' commented Stephen Strittmatter...'The potential for ALX-001 as a first-in-class oral therapy for neurodegenerative disease continues to be reinforced by a growing body of clinical evidence.'"

Media quote

Allyx Therapeutics to Present Phase 1 Data for Lead Compound ALX-001 at the 16th Clinical Trials on Alzheimer's Disease Meeting (GlobeNewswire) - "Allyx Therapeutics...disclosed its plans to present the Phase 1 single ascending dose study results at the 16th Clinical Trials on Alzheimer's Disease (CTAD) meeting in Boston on October 27, 2023....ALX-001 continues to demonstrate promise in ongoing studies that build on twelve years of research. The results are from a single ascending dose study in healthy older adults which was conducted at Yale University....Allyx Therapeutics continues to advance clinical research of ALX-001 in Alzheimer’s disease, with its Phase 1 multiple ascending dose study in healthy volunteers expected to finish in Q4 2023....New Clinical Data to be Presented on October 27."

P1 data • Trial completion date • Alzheimer's Disease

A Multiple Ascending Dose Study in Healthy Volunteers and Patients With Alzheimer's Disease (clinicaltrials.gov) - P1b | N=50 | Recruiting | Sponsor: Allyx Therapeutics | Trial completion date: Jul 2024 ➔ Nov 2024 | Trial primary completion date: Jul 2024 ➔ Oct 2024

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

Food Effect Study of BMS-984923 in Healthy Older Adult Volunteers (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Allyx Therapeutics | Trial completion date: Aug 2023 ➔ Jun 2024

Trial completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Food Effect Study of BMS-984923 in Healthy Older Adult Volunteers (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Allyx Therapeutics | Trial completion date: May 2023 ➔ Aug 2023

Trial completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Food Effect Study of BMS-984923 in Healthy Older Adult Volunteers (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Allyx Therapeutics

New P1 trial • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

A Multiple Ascending Dose Study in Healthy Volunteers and Patients With Alzheimer's Disease (clinicaltrials.gov) - P1b | N=50 | Recruiting | Sponsor: Allyx Therapeutics

New P1 trial • Alzheimer's Disease • CNS Disorders