Clinical Trials
AlgiPharma has successfully completed five clinical trials in Cystic Fibrosis, including a drug deposition study. The drug candidate has proven to be safe and well tolerated. The two most recent Phase 2b trials are now completed. Manuscripts for publication are now in preparation and expected early 2019. A further two Phase 2b trials are scheduled to start in 2019. The drug candidate for Cystic Fibrosis has Orphan Drug designation from both the European Medicines Agency and the FDA.
Safety, Tolerability and Preliminary Efficacy of Inhaled OligoG in Subjects With Cystic Fibrosis
Phase 2
ClinicalTrials.gov Identifier: NCT01465529
A Double-blind, Randomized, Placebo-controlled, Cross-over Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Alginate Oligosaccharide (OligoG) Administered for 28 Days in Subjects With Cystic Fibrosis Chronically Colonised With Pseudomonas aeruginosa.
Summary
The purpose of this study was to determine the safety and local tolerability of multiple dose administration of inhaled OligoG in CF subjects. Particular emphasis was on local, clinical tolerance, pulmonary function and pulmonary adverse events. The secondary purpose was to monitor the effect of multiple dose administration of inhaled OligoG on various efficacy variables, such as mucolytic activity, lung function, respiratory symptoms, Quality-of-Life and microbiological outcome measures.
Additional details about this clinical trial are available at www.clinicaltrials.gov
Lung Deposition of Radiolabelled OligoG in Cystic Fibrosis Patients
Phase 2
ClinicalTrials.gov Identifier: NCT01991028
An Open Label, Randomised, Two-way Crossover Scintigraphic Study to Investigate Lung Deposition of Radiolabelled OligoG Delivered as a Dry Powder and as a Nebulised Solution in Cystic Fibrosis Patients.
Summary
The purpose of this study was to evaluate and compare the lung deposition of OligoG in a new dry powder for inhalation (DPI) formulation compared with the previously used nebulised solution of OligoG. The formulations were labeled and gamma scintigraphy was used to observe pulmonary and extra-pulmonary deposition after administration of a single dose of the OligoG nebulised solution and the DPI in a cross-over design.
Additional details about this clinical trial are available at www.clinicaltrials.gov
A Study of OligoG in Cystic Fibrosis Subjects With Burkholderia Spp. Infection (SMR-2591)
Phase 2
ClinicalTrials.gov Identifier: NCT02453789
A Randomized Double-blind, Placebo-controlled Cross-over Study of Inhaled Alginate Oligosaccharide (OligoG) for 28 Days in Subjects With Cystic Fibrosis Using Aztreonam Due to Chronic Colonization With Burkholderia spp.
Summary
The purpose of the study is to assess the efficacy of the alginate oligosaccharide OligoG dry powder for inhalation in cystic fibrosis (CF) patients with a Burkholderia spp. infection. The study will evaluate the reduction in microbial burden of Burkholderia spp. as measured in expectorated sputum samples. The study will also explore the effect of inhaled OligoG on various efficacy variables such as lung function, Quality-of-Life, rheology and other microbiological outcome measures. In addition, safety, tolerability and patient compliance with treatment will also be assessed.
Additional details about this clinical trial are available at www.clinicaltrials.gov
A Phase 2b Study of OligoG in Subjects With Cystic Fibrosis (SMR-2984)
Phase 2
ClinicalTrials.gov Identifier: NCT02157922
A Double-blind, Randomized, Placebo-controlled Cross Over Study of Inhaled Alginate Oligosaccharide (OligoG) Administered for 28 Days in Subjects With Cystic Fibrosis.
Summary
The purpose of the study is assessment of efficacy and safety of OligoG as a dry powder formulation, following multiple dose administration in adult subjects with cystic fibrosis, in a cross-over design. The primary objective is to demonstrate efficacy of inhaled OligoG measured by FEV1, and supported by secondary endpoints including Mucociliary Clearance, rheology,microbiology and Quality-of-Life. The secondary objectives are to demonstrate the safety and tolerability of inhaled OligoG as a dry powder for inhalation, and to evaluate patient compliance with treatment. Mucociliary and Cough Clearance (MCC) will be an exploratory endpoint in a subset of patients, and Lung Clearance Index (LCI) an exploratory endpoint in further subset of patients.
Additional details about this clinical trial are available at www.clinicaltrials.gov
A Phase 2b Study of OligoG in Subjects With Cystic Fibrosis (ORDCF-205)
Phase 2
ClinicalTrials.gov Identifier: NCT03822455
A Phase 2b Randomised, Placebo Controlled Study of OligoG in Patients With Cystic Fibrosis
Summary
This is a phase 2B, randomised, double-blind study of alginate oligosaccharide (OligoG) dry powder for inhalation on top of standard of care in patients with Cystic Fibrosis.
The study is recruiting only in Australia. The purpose of the study is to demonstrate proof of concept that treatment with OligoG dry powder for inhalation (DPI) at a specific dose is capable of improving absolute percent-predicted FEV1 in CF patients with Pseudomonas aeruginosa (PA) lung infection. Study medication will be given twice daily for twelve weeks on top of standard of care (SOC). Thirty-three patients will be included, out of which twenty-two shall receive OligoG, and eleven shall receive placebo. A 12 month open-label extension will be available to all patients completing the 12 week blinded study.
The study is generously supported by the Cystic Fibrosis Foundation.
A Pivotal Phase 2b Dose Finding Study of OligoG in Subjects With Cystic Fibrosis (SMR-3372)
Phase 2
ClinicalTrials.gov Identifier: NCT03698448
A Randomized, Double Blind, Dose-finding Study of Inhaled Oligosaccharide (OligoG) vs Placebo in Patients With Cystic Fibrosis
Summary
The clinical trial has been designed in accordance with EMA guidelines. It will be a multi-center, randomized, double-blind, placebo-controlled, parallel group, dose finding study in patients with cystic fibrosis. The trial is divided into two parts, with part 1 designed to identify the best dose, while part 2 is designed to assess the efficacy, safety and tolerability of the inhaled alginate oligosaccharide OligoG compared to placebo after 26 weeks of treatment, followed by a 26 weeks open label extension. Randomised patients will receive daily administrations of OligoG or placebo, both administered in addition to standard of care for 26 weeks. All patients will be offered OligoG in an open label study extension of an additional 26 weeks. An Independent Data Monitoring Committee (IDMC) will assess the safety throughout the study, and select the optimal OligoG dose based on efficacy and safety data from an interim analysis performed after all subjects have received 26 weeks of treatment.
Additional details about this clinical trial are available at www.oligogpivotalcf and at www.clinicaltrials.gov
