Member News

January 12, 2015

Cutting through the gut's jungle of bacteria, Second Genome Inc. is undertaking its first study to see if its "microbiome" drug puts the brakes on a specific bacteria that drives debilitating inflammatory bowel disease.

The South San Francisco company disclosed the study Monday but was short on details, such as the specific bacterial target of the drug, called SGM-1019, its mechanism of action and how many patients are in the trial. But as the J.P. Morgan Healthcare Conference begins in San Francisco, the trial is sure to be a topic as Second Genome seeks to raise an undisclosed amount of money.

Results of the study are expected by the end of this year, said Second Genome President and CEO Peter DiLaura.

Second Genome's study is significant because it is the company's first trip to the clinic with a target it discovered while troweling the body's community of bacteria for ways to inhibit or help bacteria's role in a range of diseases.

The so-called microbiome where bacteria play is the focus of much study. In fact, there are other microbiome therapies in the clinic, such as transplanting flora from feces in Crohn's disease or, in the case of Cambridge, Mass.-based Seres Health, a mix of bacterial spores that take on the potentially deadly bacterium Clostridium difficile, or C. diff.

But 21-employee Second Genome isn't inserting bacteria in the body in the hopes that they will hop up the body's immune system, for example. Instead, in the case of SGM-1019, it wants to stop a bacteria from secreting a bioactive goo that the company believes triggers the cascade of events that leads to inflammation in the bowel.

"When people think about the microbiome, they think about fecal transplant or bacterial treatment, but we look at the interaction of the microbiome and the host," DiLaura said. "Drug discovery has been narcissistic on the host-biology side. Now we recognize that the microbiome plays a role and gives new understanding of disease biology and new, fertile ground for targets."

Second Genome has deals with Pfizer Inc. to scour the microbiome for potential obesity and diabetes drug targets and with Johnson & Johnson's Janssen Biotech unit in inflammatory bowel disease. It also inked a deal in the fall with the Mayo Clinic Center for Individualized Medicine that includes studying colorectal cancer.

But this IBD project is Second Genome's alone, DiLaura said. What's more, he said, because it is a regular drug — not a fecal transplant or other extraordinary therapy that would require navel gazing (so to speak) by the Food and Drug Administration — Second Genome can travel the regular drug-approval route.

"The regulatory path is very clear," DiLaura said. "The manufacturing and the scalability is very clear."