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AbbVie, Maker of World's No. 1 Drug, Bets on Synthetic Biology Startup

This article is more than 8 years old.

AbbVie has the top-selling drug in the world, a hit for inflammatory diseases. But as its patents age, it’s placing a bet on an edgy little MIT spinout that could, at least conceptually, do an even better job of treating inflammatory diseases of the gut.

Cambridge, Mass.-based Synlogic, a synthetic biology company built on research from the labs of James Collins and Tim Lu at MIT, is announcing today it has struck a multi-year R&D collaboration with AbbVie . Financial terms aren’t being disclosed, but AbbVie is getting worldwide rights to Synlogic’s technology for treating inflammatory bowel disease, and the research teams will focus on Crohn’s disease and ulcerative colitis.

The idea is a wild one. Synlogic essentially wants to take a live bacterium, like a probiotic, and program in some specific genetic circuitry that no other drug on the market contains today. With the genetic circuits programmed just so, the bacterium can sense the ever-changing conditions it encounters in the body, and adjust the dose of a drug based on what’s needed in the moment. (For more details on the science, subscribers can see “Why a Pfizer R&D Exec Joined Synlogic to Make Therapeutic Synthetic Life” in Timmerman Report.)

Real-time dose adjustment in the body is especially tantalizing for the treatment of autoimmune diseases, in which the immune system goes haywire and attacks healthy tissues. These inflammatory diseases like the ones treated by AbbVie’s blockbuster adalimumab (Humira) tend to wax and wane, with unpredictable flares that can be painful and disabling. Instead of bluntly suppressing the immune system all the time to prevent that from happening, Synlogic’s drug could stay in the gut for a day or two, and do nothing when nothing is needed. It would release the business part of the anti-inflammatory drug when the body needs to counteract a flare.

“You could take a synthetic biotic every day, like a probiotic,” said Jose-Carlos Gutierrez-Ramos, CEO of Synlogic, and a former Pfizer executive. “Before you have a flare, the synbiotic senses you’re having a flare, and it’s activated.”

Jim Sullivan, AbbVie’s vice president of pharmaceutical discovery, said in a statement: “AbbVie is committed to collaborating with scientific leaders with new technologies and therapeutic advances that complement AbbVie’s internal expertise.”

AbbVie, because of its long experience with Humira, knows much more about the Crohn’s and ulcerative colitis market that any little company possibly could. Nuances in the patient populations, connections to the expert physicians, understanding of what it takes to win regulatory approval and win reimbursement from payers are all there at AbbVie, Gutierrez-Ramos said.

That knowledge helps AbbVie see where the field is headed. Today, it’s OK for AbbVie to have a biologic drug targeted at the TNF inflammatory protein that delivers a 15-20 percentage point advantage in remission rates compared with placebo. But by 2025, when Synlogic’s products could reasonably be expected to reach the market, the bar will be higher for patients and payers. A successful drug will need to beat a placebo by 40 to 50 percentage points on remission rates, Gutierrez-Ramos said. That’s the goal.

Synlogic has a long way to go to get there. It raised a $29.4 million Series A venture financing in July 2013, led by Atlas Venture and New Enterprise Associates. Later, the company attracted another $5 million from the Bill & Melinda Gates Foundation. None of the company’s experimental drug candidates have yet entered clinical trials, and the company will have to take extra special care in regulatory talks with the FDA, given this isn’t a conventional pill in a bottle or liquid in a vial that regulators know well.

While AbbVie provides some of the cash and external validation that all startups yearn for, Synlogic’s business doesn’t stop there. The company is putting most of its energy into a pair of drug development programs that it still completely owns--one for phenylketonuria (PKU), and another for urea cycle disorders. These are rare diseases that a small company can tackle on a limited budget and timeframe. Gutierrez-Ramos said he expects Synlogic to bring both of those drug candidates forward into clinical trials in the first quarter of 2017.

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