AlgiPharma’s Cystic Fibrosis drug candidate OligoG awarded pivotal trial grant of €6 million from EU’s Horizon 2020 programme

An EU Horizon 2020 proposal (OligoGpivotalCF) submitted by a consortium assembled by AlgiPharma, has been successful in winning a grant of EUR 6 million to support AlgiPharma’s cystic fibrosis drug candidate OligoG through a pivotal clinical trial program.

AlgiPharma receives up to an additional $3 million from the US Cystic Fibrosis Foundation (CFF)

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 CFFECFS, 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

Click here for a pdf version of this press release.

 

AlgiPharma awarded 4 year grant from the Norwegian Research Council’s NANO2021 programme

AlgiPharma has been awarded up to NOK 10 million from the Norwegian Research Council for the project “Novel alginate oligomer products for enhanced delivery across mucosal barriers (Mucos-ALG)”.

The underlying idea for the project is to establish and optimize the design of alginate oligomers to enhance the delivery of drugs and small molecules across mucosal barriers. The project requires a combination of R&D skills and these requirements will be met through a consortium of international partners, many of whom have already worked successfully with AlgiPharma on previous R&D projects.

It is expected that the project will provide new alginate oligomer based products enabling more effective mucosal delivery for therapeutics in CF, COPD, infection and wound care.

 

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

Hilde Morris joins AlgiPharma

Hilde Morris has recently been appointed to replace our outgoing clinical director Dr. Astrid Hilde Myrset, who will continue in a consultancy in the short term to ensure a smooth transition of the role. Hilde Morris will take over the Cystic Fibrosis clinical development program at AlgiPharma. She is a veterinarian by training, and has previously held leading positions within clinical research in Nycomed-Imaging-Amersham-GE Healthcare, as well as in Photocure ASA, where she was VP of R&D until 2006. From 2007 to 2017. Hilde has worked as an independent consultant within the fields of clinical research regulatory affairs. She has had responsibility for coordinating multiple international clinical trial programs from phase I – IV for a wide range of pharmaceuticals in the US, EU and Australia, and has over 25 years’ experience interacting with international regulatory authorities.

AlgiPharma collaboration with Cardiff University wins Medical Innovation Award

A long standing collaboration between AlgiPharma and Professor David Thomas team at the School of Dentistry has been recognized this year by Cardiff University’s prestigious Medical Innovation Award. The award was presented by Dr. Rob Docherty on behalf of Cardiff University.

 

 

Click here for more information and link to the video

 

 

 

(Left to Right) Dr. Manon Pritchard (Cardiff), Dr. Phil Rye (AlgiPharma), Dr Rob Docherty (presenting the award), Prof. David Thomas (Cardiff), Dr. Katja Hill (Cardiff), Dr. Saira Khan (Cardiff), Mr Arne Dessen (AlgiPharma), Dr. Lydia Powell (Cardiff).

 

AlgiPharma Announces $4 Million Award from Cystic Fibrosis Foundation Therapeutics to Advance Clinical Development of OligoG

Sandvika, Norway, June 3, 2016. AlgiPharma AS today announced an agreement with Cystic Fibrosis Foundation Therapeutics Inc. (CFFT), Bethesda, Md., to help fund the development of its inhalable dry powder, OligoG, which has been shown to improve the properties of mucus from the CF lungs and the effectiveness of some antibiotics in early research studies. Research to date suggests that OligoG will help people with cystic fibrosis clear mucus from their lungs and potentially slow the progression of the disease.

To expedite development of OligoG for people with cystic fibrosis, CFFT committed more than $4 million to AlgiPharma. This is in addition to almost $6.9 million that CFFT has awarded so far for a Phase 2 clinical trial, bringing CFFT’s commitment to nearly $11 million.

CFFT is the nonprofit drug discovery and development arm of the Cystic Fibrosis Foundation.

AlgiPharma is currently in Phase 2 clinical trials with OligoG as a dry powder for inhalation. Two clinical trials are ongoing in Europe (recruiting in UK, Germany, Sweden, Denmark and Norway) evaluating the safety and tolerability of OligoG, and include primary endpoints to assess efficacy in individuals with CF.

OligoG works to return thick, sticky mucus toward normal, allowing it to be cleared more easily from the lungs. OligoG also may disrupt the infectious biofilm often present in the lungs of individuals with CF. Biofilm disruption might also improve antibiotic effectiveness by increasing exposure of bacteria to antibiotics.

Yngvar P. Berg, CEO of AlgiPharma, commented on the award: “We are honored and delighted that Cystic Fibrosis Foundation Therapeutics recognizes the unique therapeutic potential of our drug candidate by further supporting the development of OligoG. This CFFT award enables us to accelerate the clinical development of OligoG, and we really appreciate working with CFFT on the remaining clinical 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. This excessive sticky mucus in the lungs 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 www.cff.org.

About AlgiPharma AS:

AlgiPharma AS is a clinical stage pharmaceutical company, based on research and development carried out by FMC BioPolymer AS and the Biopolymer Foundation at the Norwegian University of Science and Technology in Trondheim, Norway, over decades. AlgiPharma was founded in August 2006.

AlgiPharma’s aim is to address unmet medical needs, fighting diseases effectively through its innovative alginate oligomer technologies, by developing products and therapies to market or license to suitable partners.

AlgiPharma AS owns or licenses all relevant patents upon which the technology platform and products are developed.

AlgiPharma AS 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 AS is a privately owned company registered and domiciled in Norway. For additional information, please visit www.algipharma.com

 

Contact:

Yngvar P. Berg, CEO: +47 67545770,  yngvar.berg@algipharma.com

June 3rd 2016

A pdf of this press release can be found here: AlgiPharma press release June 3, 2016

A Norwegian version of this press release can be found here: AlgiPharma press release June 3, 2016 Norwegian

The CFFT press release can be found here: CFFT press release June 3, 2016.

AlgiPharma features in CFF drug development pipeline

AlgiPharma now features on the Cystic Fibrosis Foundation (CFF) drug development pipeline. The CFF interactive drug development pipeline shows the progress of potential CF treatments through the different phases of clinical research. AlgiPharma’s listing in the pipeline of CF drug development reflects the progress and potential for its mucus altering and biofilm disruption alginate oligomer therapy.

Click here to find more information about the CFF interactive drug development pipeline.

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

May 4th 2016

AlgiPharma signs new license agreement with NTNU

AlgiPharma signed a new license agreement securing exclusive the global rights for the OligoG patent portfolio from the Norwegian University of Science and Technology (NTNU) for all disease areas and medical applications, except non-inhalation treatment in oncology.

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

March 9, 2016

AlgiPharma granted Orphan Drug designation by FDA

AlgiPharma was granted Orphan Drug designation by the FDA for its sodium alginate oligosaccharide, OligoG in the treatment of cystic fibrosis (CF).

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

 

February 24, 2016

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