New 2b Clinical Trial started in Australia

New Phase 2b Clinical Trial:

A phase 2b, randomised, double-blind, study of alginate oligosaccharide (OligoG) dry powder inhalation on top of standard of care compared to placebo on top of standard of care in patients with Cystic Fibrosis (CF). (ORDCF-205)

A new clinical study was initiated with a Clinical Trial Investigator Meeting held on 29th March alongside the TSANZ conference in Gold Coast, Australia. The clinical trial is a randomised, double-blinded, controlled pilot study for proof of concept that an OligoG dry powder for inhalation formulation can improve lung function in adult CF patients.  Study medication will be given twice daily for twelve weeks on top of standard of care. 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 who complete the 12 week blinded treatment study.


 

About Cystic Fibrosis:

Cystic fibrosis (CF) is a life-threatening disease that affects the lungs and digestive system and impacts about 70,000 people worldwide. CF is caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, which results in either no CFTR protein or an abnormal CFTR protein that does not function properly. The presence or absence of this dysfunctional protein causes the body to accumulate excessive levels of unusually thick mucus in the lungs, which becomes a site for infections that can require hospitalization. Respiratory distress in CF (defined as acute difficulty in breathing, infection and/or hospitalization) is most commonly related to mucus accumulation and lung infections that result in damage to lung tissue.

About AlgiPharma AS:

AlgiPharma AS is a clinical stage pharmaceutical company with headquarters in Norway. It was founded in 2006 on decades of research and development carried out by FMC BioPolymer AS and the Institute of Biotechnology at the Norwegian University of Science and Technology (NTNU) in Trondheim, Norway. AlgiPharma has completed 5 clinical trials with two formulations of its lead drug candidate, OligoG, to treat respiratory symptoms of cystic fibrosis.

AlgiPharma owns or licenses all relevant patents upon which the technology platform and products are developed. The company is supported by national and international research programs, and collaborates with a network of key opinion leaders, highly recognized academic institutions, research and patient organizations in Europe and USA.

AlgiPharma has received more than USD 37 million in research and development grants from EU’s 7th framework program, Horizon 2020, and Eurostars programs, the Norwegian Research Council, Innovate UK, US Army through Congressional Earmark funding, and the Cystic Fibrosis Foundation (CFF). Please see latest award from CFF.

AlgiPharma is a privately owned company registered and domiciled in Norway.

For additional information contact:

Yngvar P. Berg, CEO: yngvar.berg@algipharma.com

Arne Dessen, COO and Chairman of the Board: arne.dessen@algipharma.com

AlgiPharma starts two new Phase 2b trials in Cystic Fibrosis

AlgiPharma has started preparations for two new clinical phase 2b trials in cystic fibrosis patients. The two studies are:

“A double-blind, randomized, placebo-controlled cross over study of inhaled alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis.”

Yngvar P. Berg, CEO; yngvar.berg@algipharma.com
Astrid Hilde Myrset, Clinical Director; astrid.hilde.myrset@algipharma.com

“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.”

Yngvar P. Berg, CEO; yngvar.berg@algipharma.com
Philip D Rye, R&D Director; phil.rye@algipharma.com

February 2015

AlgiPharma granted permission to start Phase II trials in Cystic Fibrosis

AlgiPharma has been granted permission to start its clinical phase 2 trial in cystic fibrosis patients by the Irish Medicines Board. The study title is: 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.

Yngvar P. Berg, CEO; yngvar.berg@algipharma.com
Astrid Hilde Myrset, Clinical Director; astrid.hilde.myrset@algipharma.com

April 2011