A three-part, open-label, randomized (Part 1) and fixed-sequence (Part 2 and Part 3) study to compare the pharmacokinetics of different ESB1609 Form A formulations to that of ESB1609 Form B (Part 1) and to investigate the effect of CYP2C9 inhibition and induction on the single dose pharmacokinetics of ESB1609 Form A (Part 2 and Part 3). - CS0373-200169

Start Date20 Dec 2021

Sponsor / Collaborator

ESCAPE Bio, Inc.Startup

NL-OMON55239 / CompletedNot Applicable

A phase 1, randomized, double-blind, placebo-controlled, safety, tolerability, pharmacokinetic and biomarker study of multiple ascending doses of ESB1609 in healthy volunteers. - CS0340 ESCAPE 190526

Start Date17 Feb 2020

Sponsor / Collaborator

ESCAPE Bio, Inc.Startup

100 Clinical Results associated with ESB-1609

100 Translational Medicine associated with ESB-1609

100 Patents (Medical) associated with ESB-1609

Literatures (Medical) associated with ESB-1609

01 Jun 2023·Clinical pharmacology in drug development

A Phase 1 First-in-Human Single-Ascending-Dose Trial With ESB1609, a Selective Agonist to the Sphingosine-1-Phosphate Receptor 5

Article

Author: Dogterom, Peter ; Barlow, Carrolee ; Duong, Tram ; Sankaranarayanan, Sethu ; Cosford, Rebecca ; Ettema, Marieke ; Rubino, Christopher ; Chou, Thomas ; Singamsetty, Deepika ; Safir, M. Courtney ; Abd-Elaziz, Khalid ; France, Nicholas P. ; Maurer, Mari ; Liu, Enchi

ESB1609 is a small-mol. sphingosine-1-phosphate-5 receptor-selective agonist designed to restore lipid homeostasis by promoting cytosolic egress of sphingosine-1-phosphate to reduce abnormal levels of ceramide and cholesterol in disease.A phase 1 study was conducted in healthy volunteers to determine the safety, tolerability, and pharmacokinetics of ESB1609.Following single oral doses, ESB1609 demonstrated linear pharmacokinetics in plasma and cerebrospinal fluid (CSF) for formulations containing sodium laurel sulfate.Plasma and CSF median time to maximum drug concentration (t_max) were reached by 4-5 h and 6-10 h, resp.The delay in achieving t_max in CSF relative to plasma, likely due to the high protein binding of ESB1609, was also observed in 2 rat studies.Continuous CSF collection via indwelling catheters confirmed that a highly protein-bound compound is measurable and established the kinetics of ESB1609 in human CSF.Mean plasma terminal elimination half-lives ranged from 20.2 to 26.8 h.The effect of either a high-fat or standard meal increased maximum plasma concentration and area under the concentration-time curve from time 0 to infinity compared to the fasted state by 2.42-4.34-fold higher, but t_max and half-life remained the same irresp. of fed state.ESB1609 crosses the blood-brain barrier with CSF:plasma ratios ranging between 0.04% and 0.07% across dose levels.ESB1609 demonstrated a favorable safety and tolerability profile at exposures expected to be efficacious.

News (Medical) associated with ESB-1609

31 Mar 2021

·www.biospace.com

ESCAPE Bio to Present at Stifel’s 3rd Annual CNS Day

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- ESCAPE Bio Inc., a clinical stage company developing novel, precisely targeted therapeutics for genetic neurodegenerative diseases, today announced that Paul Wren, Ph.D., Chief Scientific Officer of ESCAPE Bio, will participate in a fireside chat at Stifel’s 3rd Annual CNS Day on Thursday, April 1, 2021, at 3:30 p.m. ET. About ESCAPE Bio ESCAPE Bio is a clinical stage, privately held biopharmaceutical company developing novel, precisely targeted therapeutics for genetically defined neurodegenerative diseases. ESB1609 is in a Phase 1 multiple ascending dose study in healthy volunteers. ESCAPE has advanced a mutant-selective LRRK2 G2019S kinase inhibitor for Parkinson’s Disease (PD) patients to IND-enabling studies. A pharmacologic structure corrector of Alzheimer's patients carrying the ApoE4 risk allele is in Discovery. For additional information, please visit .

100 Deals associated with ESB-1609

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Indication	Highest Phase	Country/Location	Organization	Date
Niemann-Pick Disease, Type C	Phase 1	US	ESCAPE Bio, Inc.Startup	06 Jan 2020

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