An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Acebilustat (CTX-4430) in Healthy Male Subjects

This is a single-centre, open-label, non-randomised, single oral dose study in healthy male subjects. It is planned to enroll and dose 6 subjects. Subjects will be admitted to the clinical unit on the evening of Day 1 prior to investigational medicinal product (IMP) administration. Subjects will be dosed on the morning of Day 1 and it is planned that they will remain resident in the clinic until up to 168 hour after dosing (up to Day 8). It is planned that subjects will be released as a group when all subjects have achieved a mass balance cumulative recovery of >90% or if <1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 hour periods.

Start Date01 Apr 2019

Sponsor / Collaborator

Celtaxsys, Inc.

[+1]

NCT02443688 / CompletedPhase 2

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients With Cystic Fibrosis

This study is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of CTX-4430 administered once-daily for 48 weeks for treatment of CF.

Start Date30 Oct 2015

Sponsor / Collaborator

Celtaxsys, Inc.

NCT02385760 / CompletedPhase 2

A Multi-centre, Double-blind, Randomized, Parallel Group, Placebo Controlled Efficacy and Safety Study of Oral CTX-4430 for the Treatment of Moderate to Severe Facial Acne Vulgaris

A multi-centre, double-blind, randomized, parallel group, placebo controlled efficacy and safety study of oral CTX-4430 for the treatment of moderate to severe facial acne vulgaris.

Start Date01 Apr 2015

Sponsor / Collaborator

Celtaxsys, Inc.

[+2]

100 Clinical Results associated with Celtaxsys, Inc.

0 Patents (Medical) associated with Celtaxsys, Inc.

Literatures (Medical) associated with Celtaxsys, Inc.

01 Nov 2021·Journal of Cystic FibrosisQ2 · MEDICINE

Empire-CF study: A phase 2 clinical trial of leukotriene A4 hydrolase inhibitor acebilustat in adult subjects with cystic fibrosis

Q2 · MEDICINE

Article

Author: Mershon, John ; Springman, Eric ; Ahuja, Sanjeev ; Rowe, Steven M ; Sutharsan, Sivagurunathan ; Grosswald, Ralph ; Fajac, Isabelle ; Horsley, Alexander ; Daines, Cori L ; Aaron, Shawn D ; Lucidi, Vincenzina V ; Downey, Damian G ; Elborn, J Stuart ; Uluer, Ahmet ; Taylor-Cousar, Jennifer L ; Konstan, Michael W

BACKGROUNDCystic fibrosis (CF) is characterized by neutrophilic inflammation in the airways. Leukotriene B4 (LTB₄) is a neutrophil chemoattractant and has been implicated in CF pathogenesis. Acebilustat, a novel, synthetic, small-molecule leukotriene A4 hydrolase inhibitor, reduces LTB₄ production. We report findings from a randomized placebo-controlled trial of acebilustat in adult subjects with mild-to-moderate lung disease.METHODSSubjects were randomized (1:1:1) to once-daily acebilustat 50 mg, 100 mg or placebo for 48 weeks, concomitantly with their current therapeutic regimen. Subjects were stratified by use of concomitant CF transmembrane conductance regulator (CFTR) modulators, baseline percent predicted forced expiratory volume in 1 second (ppFEV₁) 50-75 and >75, and number of pulmonary exacerbations in the past year (1 or >1). Primary endpoints were the change from baseline in ppFEV₁ and safety. Secondary endpoints included the rate of pulmonary exacerbations.RESULTSOverall, 199 subjects were randomized and dosed (acebilustat 50 mg, n=67; acebilustat 100 mg, n=66; placebo, n=66). Baseline demographics and disease profile were well balanced among treatment groups. Acebilustat had no statistically significant effect on the primary endpoint of change in ppFEV₁ at week 48 or the secondary endpoint pulmonary exacerbations. There was a trend towards reduced pulmonary exacerbations in subjects receiving acebilustat in pre-specified populations with ppFEV₁>75 (35% rate reduction) and those on concomitant CFTR modulator therapy (20% rate reduction). Acebilustat was well tolerated.CONCLUSIONSAcebilustat did not improve lung function. A trend towards reduced pulmonary exacerbations in subjects with an earlier stage of lung disease suggests a potential effect in this population.

01 Sep 2018·Contemporary Clinical TrialsQ4 · MEDICINE

EMPIRE-CF: A phase II randomized placebo-controlled trial of once-daily, oral acebilustat in adult patients with cystic fibrosis – Study design and patient demographics

Q4 · MEDICINE

Article

Author: Mershon, John ; Grosswald, Ralph ; Springman, Eric ; Rowe, Steven M ; Elborn, J Stuart ; Ahuja, Sanjeev

Inflammation causes irreparable damage in the cystic fibrosis (CF) lung. Despite high standards of care and the advent of new therapies, inflammation continues to cause significant loss of lung function and morbidity. Acebilustat is a once-daily, oral molecule with anti-inflammatory activity through the inhibition of LTA4 hydrolase and modulation of LTB4. It has potential to reduce lung function decline and pulmonary exacerbations in patients with CF and is currently being tested in a Phase II multicenter, randomized, double-blind, placebo-controlled, parallel-group study (EMPIRE-CF). Strict inclusion criteria based on modeling of the Cystic Fibrosis Foundation Patient Registry data were selected to enrich the trial with patients most likely to benefit from chronic anti-inflammatory therapy that reduces lung function decline. 200 patients between 18 and 30 years of age, with an FEV₁ percent predicted (pp) ≥50%, and ≥1 exacerbation in the past year have been enrolled. Patients are randomized 1:1:1 to placebo, acebilustat 50 mg or 100 mg for 48 weeks, taken concomitantly with their current standard of care, and stratified based on concomitant CFTR modulator use, baseline FEV₁pp (50% to 75% and >75%), and number of exacerbations in the past year (1 or >1). The primary endpoints are absolute change from baseline in FEV₁pp and safety outcomes. Secondary endpoints include rate of pulmonary exacerbations and time to first pulmonary exacerbation. Biomarkers of inflammation will also be assessed. EMPIRE-CF is expected to identify the optimal patient population, dose, duration and endpoints for future acebilustat trials, and widen understanding of the drug's efficacy in patients with CF.

01 Oct 2017·Seminars in Immunology

Recent advances in clinical development of leukotriene B4 pathway drugs

Review

Author: Bhatt, L ; Springman, E B ; Van, T ; Roinestad, K

The LTB4 pathway is an attractive target for therapeutic drug development. Two broad classes of drugs have been pursued: antagonists of the primary LTB4 receptors (BLT1 and BLT2) and inhibitors of LTA4 Hydrolase (LTA4H), the rate limiting enzyme in the production of LTB4. An initial wave of effort culminated in the 1990s. Over the past 15 years, a second wave of more selective drug candidates, including at least 5 BLT antagonists and 6 LTA4H inhibitors, have reached Phase 2 clinical trials. Despite the extensive efforts to discover and develop LTB4 pathway targeting drugs, only one has reached the market to date. Recently discovered complexities in the pathway and challenges in matching pathway intervention with therapeutic effect could explain the limited clinical success of LTB4 pathway drugs, even though there is a large body of scientific evidence linking LTB4 to human diseases and demonstrating efficacy of these compounds in a wide array of preclinical models. Herein, we describe the clinical programs for the most prominent recent examples from each broad class and discuss the clinical outcomes and their implications for future development of LTB4 pathway drugs.

100 Deals associated with Celtaxsys, Inc.

100 Translational Medicine associated with Celtaxsys, Inc.

Corporation Tree

Boost your research with our corporation tree data.

view full example data

Pipeline

Pipeline Snapshot as of 26 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Phase 2 Clinical

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

CRC-3357	Acne Vulgaris More	Phase 2
CTX-4398	Multiple Sclerosis More	Pending
CTX-3397 ( LTA4H )	Multiple Sclerosis More	Pending
CTX-4273	Inflammation More	Pending
Acebilustat ( LTA4H )	Pneumonia More	Pending

Deal

Boost your decision using our deal data.

view full example data

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Profit

Explore the financial positions of over 360K organizations with Synapse.

view full example data

Grant & Funding(NIH)

Access more than 2 million grant and funding information to elevate your research journey.

view full example data

Investment

Gain insights on the latest company investments from start-ups to established corporations.

view full example data

Financing

Unearth financing trends to validate and advance investment opportunities.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis