Clinical Development Programme
The AlgiPharma drug candidate OligoG has proven to be safe and well tolerated. AlgiPharma has successfully completed five clinical trials including a drug deposition study in Cystic Fibrosis patients. A Phase 2b trial is currently running in Australia, with another Phase 2b scheduled to start in Europe H1 2020. The drug candidate for Cystic Fibrosis has Orphan Drug designation from both the European Medicines Agency and the FDA.
OligoG for the treatment of cystic fibrosis (CF)
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.
The disease is caused by a defective gene that results in the accumulation of mucus in the respiratory tract, pancreas, intestine and other organs. The excess of thick mucus in the lungs makes patients susceptible to serious and recurring lung infections that are difficult to eradicate, eventually leading to permanent lung damage. Patients also suffer from digestive abnormalities resulting in pain, bloating, constipation and intestinal obstruction also known as DIOS (distal intestinal obstructive syndrome).
Some CF patients may take as many as 30+ different medications and supplements every day, and in the western world the predicted median age of survival for a person with CF is in the mid 40’s.
AlgiPharma’s two product candidates for CF include a dry powder for inhalation (DPI), and a solution for nebulisation containing Oligo-G. The DPI drug is inhaled using a monodose dry powder inhaler.
Results from pre-clinical models and clinical trials have shown that the drug candidate reduces the viscosity of CF sputum and improves the efficacy of antibiotics.
Reduction in sputum viscosity will enable patients to ease clearing of mucus from the lungs and airways and thus reduce microbial burden and reduce the need for physical therapy.
The potentiating effect on antibiotic treatment may also increase efficacy in eradicating the bacteria causing respiratory infections, a common complication for CF patients.
Phase 1, 2a, 2b, and drug deposition studies have shown that the product candidate is safe and well tolerated.
OligoG for the treatment of chronic obstructive pulmonary disease (COPD)
COPD is a lung disease most commonly caused by smoking and airborne pollutants. Global prevalence of the disease for people over the age of 40 is estimated to about 9%. The World Health Organization estimates that 240 million people world-wide are afflicted by COPD. Recurring lung infections are often cited as the main cause of exacerbations in COPD patients.
Similar to the mechanism of action in cystic fibrosis the OligoG drug candidate may also help to regulate mucus viscosity and eradicate bacterial lung infections. AlgiPharma’s product candidate is intended to be used in combination with existing therapies, for patients with moderate to severe clinical manifestation.
OligoG for the treatment of chronic infections
Antibiotic resistance is an increasingly serious threat to global health. Inappropriate use of antimicrobial drugs favours the emergence and selection of resistant strains. Poor infection prevention and control practices further contribute to the spread of antimicrobial resistance. New strategies are needed to manage chronic infections and reduce the use of antibiotics that add to this selection pressure.
AlgiPharma’s alginate oligomer can address this challenge by disrupting the defense mechanisms that bacteria use to evade not only antibiotics but also host immune defenses. OligoG has been shown to disrupt microbial biofilms making them more susceptible to antibiotic treatment and eradication. OligoG has also been shown to reduce the motility of bacteria, which in turn reduces their virulence. OligoG has also been shown to reduce the amount of antibiotics needed to eradicate infections.
Beneficial effects of OligoG treatment have been clearly demonstrated in animal models of lung infection, subcutaneous infection, and polymicrobial infected burn wounds and strongly supports the role for OligoG in the treatment of microbial infections.
AlgiPharma is developing new formulations to be used in combination with antimicrobial therapies to improve their efficacy.
