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The AlgiPharma alginate oligomer technology, OligoG technology, can be formulated into several products aiming to treat microbial infections and respiratory diseases, and to treat and improve healing of infectious wounds and burns.
OligoG for the treatment of cystic fibrosis (CF) AlgiPharma’s initial product candidate is a sterile solution for inhalation containing OligoG for treatment of CF patients. The inhalable aerosol is generated by a nebulizer. Results from model system studies and trials on samples obtained from CF patients have shown that the drug candidate is able to reduce the viscosity of CF sputum and improve the efficacy of antibiotics. The reduction in sputum viscosity may enable patients to ease clearing of mucus from the lungs and airways and thus reduce the need for physical therapy. The potentiating effect on antibiotic treatment may increase efficacy in eradicating the bacteria causing respiratory infections, a common complication for CF patients.
The results from the first phase 1 clinical study involving healthy volunteers showed that the product candidate was well tolerated and that all adverse events were mild and transient and did not occur more frequent in the active group compared to the placebo group. There were no serious adverse events, not death or discontinuations, and no clinically significant changes in laboratory values, vital signs, ECG or spirometry. Pharmacokinetic data from the study showed no systemic absorption above the level of quantification.
CF is an autosomal, recessive inheritable genetic disease affecting 70,000-80,000 patients world-wide. It has the highest incidence and prevalence in Caucasian populations and is less common in other population groups. One of the symptoms of the disease is mucus stasis (viscous slime) in the lungs that make patients susceptible to serious and recurring lung infections that are difficult to eradicate and that eventually lead to permanent lung damage. Patients also suffer from digestive and fertility problems. The disease is treated with inhalable mucolytic agents (reducing the mucus viscosity) and inhalable antibiotics as well as enzymes and vitamins for digestion and nutritional uptake. Some patients take as many as 34 different medications and supplements every day. In the western world, the predicted median age of survival for a person with CF is in the mid 30’s.
OligoG for the treatment of chronic obstructive pulmonary disease (COPD) AlgiPharma’s product candidate for the treatment of COPD is intended for patients within the range of moderate to severe clinical manifestation. The OligoG based medicinal candidate is intended used with existing therapies primarily in connection with exacerbations. As in the CF case, this COPD drug candidate may help to regulate mucus viscosity and eradicate bacterial lung infections. Reoccurring lung infections are often cited as the main cause of exacerbations in patients suffering from this disease.
The results from the first phase 1 clinical study are described above under cystic fibrosis.
COPD is a lung disease most commonly caused by smoking. Global prevalence of the disease for people over the age of 40 is estimated to about 9%. WHO estimates that 240 million people world-wide are afflicted by COPD. Global Strategy for the Diagnosis, Management and Prevention of COPD, GOLD, states the following: Chronic Obstructive Pulmonary Disease (COPD) is a preventable and treatable disease with some extra-pulmonary effects that may contribute to the severity in individual patients. Its pulmonary component is characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and associated with an abnormal inflammatory response to noxious particles or gases.
OligoG for the treatment of infectious diseases AlgiPharma’s alginate oligomer has a proven ability to disrupt microbial biofilm and to potentiate the effect of antibiotics and making the bacteria more susceptible to antibiotic treatment. This may make it ideal for a variety of products intended to treat different kinds of bacterial infections. Results from the preclinical test program are so far very promising showing significant increase in antibiotic efficacy and bacterial susceptibility. AlgiPharma are currently conceptualizing various product formulations.
OligoG for the treatment of wounds and burns AlgiPharma is developing new products for treatment of wounds and burns. The products will be intended to help eradicate bacterial biofilm infections that often develop in wounds and burns and to increase the efficacy of antimicrobial therapy. Infections impair and delay wound healing and complicate treatment. Effective and safe eradication of biofilm infections, and other microbial infections, should facilitate and improve both wound and burn healing.
Chronic infectious wounds, or slow-healing wounds, may develop from any acute wound if the host wound healing ability is sufficiently impaired and/or the healing conditions are compromised. Examples of pathogenic bacteria producing biofilms are Pseudomonas aeruginosa, Staphylococcus aureus, etc.
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