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ll-37 antimicrobial peptide rct 2014-01-28 ClinicalTrials

GSK2793660 Bronchiectasis Drug Candidate Terminated in Early Clinical Trial

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Food Effect of Single or Repeat Doses of GSK2793660 in Healthy Subjects

Background

This study addressed Bronchiectasis, a chronic and progressive lung condition characterized by persistent inflammation, recurrent infections, and irreversible widening of the airways. Patients with Bronchiectasis often experience debilitating symptoms like chronic cough, sputum production, and frequent exacerbations, leading to significant morbidity and reduced quality of life. Current treatments primarily focus on symptom management and infection control, highlighting a critical unmet need for novel therapeutic agents that can address the underlying disease mechanisms. This Phase I trial aimed to evaluate the fundamental safety, tolerability, and pharmacological profile of a new investigational compound, GSK2793660, in humans, a crucial first step before testing in patients.

Results

Due to the termination of this clinical trial, no specific efficacy or detailed safety data from the administration of GSK2793660 to healthy subjects has been publicly disclosed. The primary objectives of evaluating the safety, tolerability, and comprehensive pharmacokinetic and pharmacodynamic profiles of GSK2793660 across various single and repeat doses were not fully realized or reported in a public domain. Consequently, there are no quantitative comparisons available between the GSK2793660 treatment groups and the placebo group regarding drug levels, adverse events, or preliminary pharmacodynamic markers. This lack of data means we cannot report on specific drug concentrations, half-lives, or any observed biological effects. > The most critical outcome is the termination of the study, meaning that GSK2793660 did not proceed through its planned Phase I evaluation, and no comprehensive safety, tolerability, or pharmacokinetic data was publicly reported from this trial. This termination prevents any conclusive statements about the drug's potential benefits or risks in healthy subjects or its applicability to Bronchiectasis.

Why It Matters

The termination of this early-phase study for GSK2793660 highlights the significant challenges and high attrition rates inherent in drug development, especially for complex and chronic conditions like Bronchiectasis. This outcome implies that either safety concerns arose, the pharmacokinetic profile was unfavorable, or the sponsor, GlaxoSmithKline, made a strategic decision to discontinue its development for this indication. This means that GSK2793660 will not be moving forward into further clinical trials for Bronchiectasis, at least not in its current form or for this specific indication, leaving the unmet medical need for novel therapies in this area unaddressed by this particular compound. Future research efforts will need to focus on alternative compounds or mechanisms to provide new treatment options for patients suffering from Bronchiectasis.


ll-37 antimicrobial peptide cathelicidin safety data present
Source: clinicaltrials:NCT02058407 · Ingested 2026-04-03 · Digest: gemini-2.5-flash