Seasoned entrepreneur Nancy Briefs on her startup’s daring swing at Type 2 diabetes. AltrixBio is creating a pill that simulates the benefit of the best gastric bypass surgery: remission of diabetes in 80 percent of cases. With co-founders Jeff Karp and Ali Tavakoli, she is re-purposing an existing treatment with a great safety profile to address this daunting problem.
Highlights include:
Nancy Briefs, co-founded 7 companies and managed or been on the board of several others.
Together with Dr. Karp and Dr. Tavakoli of Brigham & Women’s Hospital, Nancy co-founded AltrixBio to emulate the results of gastric bypass in a pill.
Sal saw Nancy pitch at MIT Angels and Walnut Ventures and was impressed.
Ali Tavakoli, M.D. performs the Roux-en-Y procedure which is the gastric bypass operation with the best record of success.
Dr. Tavakoli and others observed that diabetic patients who had the procedure had their Type 2 diabetes go into remission about 80 percent of the time.
Seven and a half years ago, upon observing this phenomenon, Dr. Tavakoli approached Jeff Karp, PhD, who trained at MIT’s renowned Langer Lab and works on new ways to deliver treatments to the body, wondering if the results could not be duplicated using a pill.
The Roux-en-Y is irreversible and has considerable side effects. Drs. Karp and Tavakoli set to finding a reversible and benign way of mimicking the results of the procedure.
Needless to say: Type 2 diabetes is a huge problem that currently eats up one in four dollars spent on healthcare. It a global problem.
The team zeroed in on Sucralfate, a drug presently used to treat peptic ulcers that could be modified to produce the desired outcome. Sucralfate is designed to stick only to the ulcers. The modified Sucralfate can be made to adhere to the healthy lining of the digestive tract.
The re-engineered drug, called LuCI™, thus, in theory, could be used to coat strategic parts of the intestine to control the uptake of sugar by the patient’s body.
LuCI™ was tested on mice with encouraging results.
There is at present no drug that can cause diabetes to go into remission reliably.
The treatment is expected to make part of the digestive system unavailable to nutrients only part of the day. The dosage would permit absorption of critical nutrients the rest of the time.
An interesting quality of LuCI™ is that it is easy to tune how long it stays in the gut.
It is a platform that could be adapted, due to its versatility, to treating other diseases such as NASH or for the targeted delivery of biologics which are highly perishable in the body.
Sal loves platforms. SQZ Biotech, Savran tech etc. Nancy says: it gives you more shots on goal.
Plus: Sucralfate has a 30-year safety record, which could simplify the approval process.
It has an expedited FDA approval path, given the history. It’s possible there could be a signal that it works in humans with the investment of five to seven million dollars.
Sal loves platforms. SQZ Biotech, Savran tech etc. Nancy says: it gives you more shots on goal.
Plus: Sucralfate has a 30-year safety record, which could simplify the approval process.
It has an expedited FDA approval path, given the history. It’s possible there could be a signal that it works in humans with the investment of five to seven million dollars.
Sal talks about portfolio company SQZ Biotech.
Nancy explains how an angel can make money investing in an early stage company. Hint: value creation needs to outpace fundraising by a lot.
Nancy Briefs mentions the acquisition of Tilos Therapeutics by Merck for $773 million as an example of the type of exit possible.
Silicon Valley Bank study reveals that 80% of companies are acquired at Phase II trials. She believes AltrixBio could be through Phase II trials in four years.
Repurposing a drug such as Sucralfate that has a 30-year record of safety with the FDA can greatly shorten and the time to approval and reduce the cost from hundreds of millions to tens of millions
The FDA has the files from the five generic suppliers of Sucralfate that show no heart risk, no cancer risk etc.
The near-term inflection points for AltrixBio is (1) moving the compounding of the drug from the lab to an outside supplier, Catalant, and (2) once there is usable formulation of the drug AltrixBio will have a “pre-IND” meeting with the FDA to get initial guidelines for the approval process such as how many subjects will be required and what they acceptable endpoints might be in the first clinical trials. This information is expected to de-risk the investment substantially and to allow a sharper focus on how much money will be needed to fund clinical trials through Phase II.
At the end of 2020, AltrixBio will already be at first-in-human trials and to have enrolled 15 to 20 patients.
Nancy recalls pivotal times in her career. As a young sales rep for Pfizer she was impressed by a heart valve surgery she witnessed and realized at that moment that she wanted to spend her life in healthcare. Nancy’s decision to work in healthcare was reinforced by getting her MBA.
Nancy recollects the various positions she had and what she got out of it.
Nancy’s father ran a Pillsbury plant. Her mother was a small banker.
Nancy discovered leadership early. She was student body president at her high school.
Innovation = Invention X Commercialization, Ed Roberts from MIT/ Sloan
Nancy says that in order to have a business in biotech you need a platform technology.
Nancy talks about the work patent attorney Peter Fasse of Fish & Richardson is doing for AltrixBio.
Nancy’s decision to found her first company came from the conviction that all the work she had done as an executive and board member had prepared her to take the leap.
Taking a company through an IPO with Goldman Sachs back in the 1990s taught Nancy the importance of being able to convey a compelling narrative about the company.
Speaking of the daring required to start a company, Sal recalls his business partner Bob Smith’s audacious but well-founded belief that he could build his business in competition with big Wall Street names.
Nancy’s views on de-risking startups is consonant with Jeff Arnold’s.
Being an entrepreneur is wonderfully fun. Nancy finds Massachusetts a great place to build a biotech company.
Sal notes that Boston is a big exporter of ideas and a big importer of capital. Two third of Series A funding of Boston companies is from outside Massachusetts.