AzurRx brings on longtime drug developer James Pennington as CMO

James Pennington has joined AzurRx BioPharma as its chief medical officer as the company aims to launch a phase 2 clinical trial of its lead candidate in cystic fibrosis later this year.

During his time as Bayer’s VP for biological clinical research in the late '90s, Pennington helped secure 10 FDA approvals and 10 approvals overseas. Since then, he has held CMO roles at Anthera Pharmaceuticals, InterMune and CoTherix, and served as senior VP of research, development and clinical affairs at Alpha Therapeutics.

He has also participated in several FDA advisory committees, editorial boards and professional societies. Currently, he is a clinical professor of medicine at the University of California, San Francisco.

“We are delighted to welcome Jim to the senior management team as we rapidly advance our clinical programs,” said AzurRx CEO Thijs Spoor, calling 2018 a pivotal year for the company. “Jim is a highly accomplished pharmaceutical industry executive with extensive medical and clinical experience, as well as hands-on experience in regulatory affairs.”

AzurRx’s lead product, MS1819, is an oral, autologous yeast recombinant lipase for the nonsystematic treatment of exocrine pancreatic insufficiency—the inability to properly digest food stemming from a lack of digestive enzymes produced by the pancreas—and is being studied in chronic pancreatitis and cystic fibrosis. It’s also in the early stages of research for the prevention of hospital-acquired infections.

“MS1819, which has generated promising interim results in the ongoing study in chronic pancreatitis patients, addresses a billion-dollar market in exocrine pancreatic insufficiency,” Pennington said in a statement. “It has the potential to become best-in-class due to the high pill burden, patient compliance issues, and manufacturing/supply chain challenges of the current animal-derived therapies.”

In April, AzurRx announced data on the first nine patients treated in a phase 2a dose-escalation trial showing clinical activity, with the highest-dose cohort demonstrating greater than 21% improvement in the coefficient of fat absorption. Positive trends were also seen in other endpoints, such as Bristol stool scale, number of daily evacuations and the weight of stool, the company said.

In 2016, the New York-based AzurRx raised $5 million through a discounted IPO, dropping its price per share to $5.50, down from its lowest range of $6 to $8. The company’s scientific operations are based in Langlade, France.