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

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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

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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

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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

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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

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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 awarded four year grant from Norwegian Research Council

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AlgiPharma has been awarded a new four year grant from the Norwegian Research Council for the project “Treatment of Chronic Infective Disease with Alginate Oligomer Based Formulations”. This study will focus on extended long term safety studies and formulation changes to further develop the AlgiPharma drug candidate OligoG for the treatment of cystic fibrosis.

For further information, please contact:
Arne Dessen, Chairman of Board; arne.dessen@algipharma.com
Philip D. Rye R&D Director; phil.rye@algipharma.com

February 2015

Technology Strategy Board (Innovate UK) & Innovation Norway – New Funding Success

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Building on the previous success with the AlgiFerm project, AlgiPharma, together with leading experts in fermentation at the Centre for Process Innovation (CPI, Redcar, UK), FMC Biopolymer, and SINTEF have secured additional funding from the UK’s Technology Strategy Board (now Innovate UK) and Innovation Norway for further investigation on microbial production of AlgiPharma’s promising new alginate oligomer drug candidate, OligoG. The study will focus on developing methods for scaling-up microbial fermentation production of OligoG at CPI.

The project, ALGIPRO, is an innovative collaborative effort between Norway and the UK. It will translate over 20 years of academic research into an industrial scale production process for alginates. The Centre for Process Innovation Ltd. (UK) is leading the scale-up based on development by SINTEF (Norway). AlgiPharma AS (Norway) will use the product as the Active Pharmaceutical Ingredient in its development of medicines for cystic fibrosis, COPD and chronic wounds. FMC Biopolymer (UK, Norway) will market the product in existing and new applications within the food and pharmaceutical markets. If successful ALGIPRO  will facilitate the introduction of novel medicinal products to the market that will ease patient suffering and potentially reduce healthcare costs. In addition it will be a new tool in fighting multi-drug resistant bacteria. The project is funded through a joint UK-Norwegian initiative between the Technology Strategy Board and Innovation Norway.

For further information, please contact:
Arne Dessen, Executive Chairman; arne.dessen@algipharma.com
Philip D. Rye R&D Director; phil.rye@algipharma.com

November 2014

Technology Strategy Board & Innovation Norway – Algiferm Project Success

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The collaboration project initiated by AlgiPharma, together with leading experts in fermentation at the Centre for Process Innovation (CPI, Redcar, UK), has been successful in achieving the project milestones. The participating groups which include CPI, SINTEF and AlgiPharma, have successfully demonstrated the feasibility for industrial scale microbial fermentation production of AlgiPharma’s promising new alginate oligomer drug candidate, OligoG. This is a significant step forward in AlgiPharma’s development of its alginate oligomer technology. These results will facilitate the introduction of novel medicinal products to fight infection and disease, reducing patient suffering and potentially reduce healthcare costs. The project was funded through a joint UK-Norwegian initiative between the Technology Strategy Board and Innovation Norway.

For further information, please contact:
Arne Dessen, Executive Chairman; arne.dessen@algipharma.com
Philip D. Rye R&D Director; phil.rye@algipharma.com

January 2014

AlgiPharma awarded four year grant from Norwegian Research Council

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AlgiPharma has been awarded a four year grant from the Norwegian Research Council for the project “Tailored OligoG in the treatment of chronic infectious biofilms”. This study involving an international consortium will investigate microbial sources of raw material for AlgiPharma’s alginate technology and determine optimal oligomer length associated with specific known OligoG antimicrobial properties.

For further information, please contact:
Arne Dessen, Chairman of Board; arne.dessen@algipharma.com
Philip D. Rye R&D Director; phil.rye@algipharma.com

July 2013

Technology Strategy Board & Innovation Norway – New Funding Success 

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A collaboration project initiated by AlgiPharma, together with leading experts in fermentation at the Centre for Process Innovation (CPI, Redcar, UK), has secured funding (2.700.000 NOK) from the UK’s Technology Strategy Board and Innovation Norway for a feasibility study on microbial production of AlgiPharma’s promising new alginate oligomer drug candidate, OligoG. The 9 month study will focus on developing methods for the pilot scale microbial fermentation production of OligoG at CPI, with support from our partners at SINTEF, who provide the essential expertise in laboratory scale fermentation of alginates.

The alginate oligomer fermentation project, ALGIFERM, translates 20 years of academic research into an industrial scale feasibility study. The Centre for Process Innovation Ltd.(UK) is leading the scale-up, whereas AlgiPharma AS (Norway) needs the final product as an Active Pharmaceutical Ingredient in its development of medicines for cystic fibrosis, COPD and chronic wounds, like diabetic foot ulcers. The biofilm disrupting and antibiotic potentiating technology that has been developed by AlgiPharma was recently published (Khan S., et al., Antimicrob Agents Chemother. 2012;56(10):5134-41). If the scale-up is successful it will facilitate the introduction of novel medicinal products to the market that will ease patient suffering and potentially reduce healthcare costs. In addition it will be a new tool in fighting multi-drug resistant bacteria. Both AlgiPharma and CPI will obtain help from SINTEF (Norway), in this innovative collaborative effort between Norwegian and English researchers.

The project is funded through a joint UK-Norwegian initiative between the Technology Strategy Board and Innovation Norway.

For further information, please contact:
Arne Dessen, Executive Chairman; arne.dessen@algipharma.com
Philip D. Rye R&D Director; phil.rye@algipharma.com

April 2013