AlgiPharma AS announced an agreement with Cystic Fibrosis Foundation (CFF), Bethesda, MD., that will provide up to $3 million to support further research and development of AlgiPharma’s drug candidate (OligoG) for the treatment of people with cystic fibrosis. This is in addition to more than $11.5 million already received from the Cystic Fibrosis Foundation for Phase 2 clinical work.
OligoG is an alginate oligosaccharide derived from seaweed, and is a new class of drug being developed to help people with cystic fibrosis clear stagnant and highly viscous mucus from their lungs. It is anticipated that OligoG will help to slow progression of the disease.
In a previous clinical 2b trial the primary efficacy endpoint (improved lung function as measured by FEV1, or forced expiratory volume in 1 second) was not achieved at 28 days across the entire study population. However, more detailed analyses showed that several subgroups demonstrated significant improvement in FEV1, showing more than 9% improvement in lung function by day 28, with further improvement in the subsequent washout period. A new clinical trial is being planned to optimize dosing to match these subgroups, which represent the majority of the CF patient population.
AlgiPharma has to date completed five clinical trials with a total safety population of 169 subjects, and has demonstrated an exemplary safety record.
Yngvar P. Berg, CEO of AlgiPharma, commented on the award: “We are honored and delighted that the Cystic Fibrosis Foundation recognizes the unique therapeutic potential of our drug candidate by further supporting the development of OligoG. The award from the CFF will be complementary to EUR 6 million from its EU Horizon 2020 grant (‘OligoGpivotalCF’) to perform a pivotal clinical trial program with OligoG. This CFF award enables us to accelerate the development of OligoG, and we really appreciate working with the Foundation on the remaining development path in bringing this new drug to people with cystic fibrosis.”
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.
For more information on CF, please visit the individual websites at CFF, ECFS, CF-EUROPE
About AlgiPharma AS:
AlgiPharma AS is a clinical stage pharmaceutical company, 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
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