Pharmaceutical firm AzurRx BioPharma Inc (NASDAQ:AZRX) has revealed that in collaboration with French pharmaceutical company, Mayoly Spindler, the two firms have received approval to add a site in France for a trial on exocrine pancreatic insufficiency that is brought about by chronic pancreatitis. The approval was received from ANSM, a French regulatory agency, as well as the Ethics Committee.
Previously AzurRx BioPharma had submitted an IMPD – Investigational Medicinal Product Dossier for MS1819, a lead product meant to treat exocrine pancreatic insufficiency brought about by cystic fibrosis as well as chronic pancreatitis. As a result of the deficiency patients are unable to properly digest food, a condition known as maldigestion. Symptoms of the deficiency include weight loss, fecal urge and greasy diarrhea.
Safety profile of MS1819-SD
With the phase II trial the primary objective is to look into the safety profile of MS1819-SD when the doses are escalated in patients. The second goal is to look into the efficacy profile of MS1819-SD in patients. An assessment of the safety profile of the treatment will be conducted upon the conclusion of the treatment period. Particular attention will be paid to digestive symptoms and immunoallergic effects.
“Following on from our recently announced $2.0 million financing, we are delighted to have received regulatory approval to add a French clinical trial site, the Hopital Latimone in Marseille, for our MS1819 program,” the chief executive officer of AzurRx BioPharma, Thijs Spoor, said.
No serious side effects
In a previous study MS1819-SD was found to have no serious side effects and was well tolerated. At the moment there are about 100,000 people in the United States who are suffering from exocrine pancreatic insufficiency brought about by chronic pancreatitis per data obtained by National Pancreas Foundation.
Additionally there are 30,000 people suffering from exocrine pancreatic insufficiency brought about by cystic fibrosis according to the same body. Currently the treatment consists of replacement pills for the porcine pancreatic enzyme. Last year the market for these pills in the United States was about $1.1 billion while globally it was $1.6 billion per estimates from Wall Street and IMS data.