6.6.24: MIT STEX Demo Day - Bilayer Therapeutics

THOMAS A. COLLET: Hi. Thank you very much. I hope you can understand me OK.

Bilayer is an MIT spin-off company that's developing first-in-class therapies for obesity and diabetes. Team members are Bob Langer, Gio Traverso, who are both on faculty at MIT. We've licensed some intellectual property from MIT as well, and I'm an MIT alum in biochemistry.

The problem we're tackling is obesity, and I don't think I have to explain in detail why that's important given that 42% of the US adults are obese already. The good news that you've probably followed in the press as well is that there are now multiple drugs and drug candidates that are very effective in reducing body weight up to reductions of about 26% body weight. But the fly in the ointment is that these drugs have a significant number of side effects, which are listed on the left side of the slide, primarily nausea, vomiting, diarrhea, but also side effects of severe gastrointestinal blockage and of lean muscle mass.

And that is, in fact, leading to patients abandoning these drugs quite rapidly. So as you can see on the right, diabetic patients that are started on this class of drug, 50% of them drop within the first year, and 70% drop off them within the first two years. So the unmet need really here is what is called patient stay time on drug.

Now, our solution is a combination of the delivery of bile acids, which are naturally occurring compounds that increase the levels of several nutrient-stimulated hormones, including GLP-1 and GLP-2. And our preferred bile acid, sodium chenodeoxycholate, in fact does this with quite moderate side effects compared to the other drugs that I mentioned before. And what we're adding to this solution is the delivery technology, which is proprietary and which targets delivery directly to the colon.

So basically our approach for the treatment of obesity is going to be that the seven mechanisms of action that we can activate with the delivery of bile acid is going to be more potent and more benign than the activity conveyed by the three mechanisms of action that are encapsulated by drugs that are currently approved.

So our solution is a bilayer tablet. I'm not going to go into detail on how this works. We have a very nice animation on our website. But it's basically a tablet that has an enteric coating that targets this drug to the colon, and then it has a bilayer core which has biphasic PK, which is optimized for the complete and even treatment of the colon.

The side effects are quite benign because we're using an already-approved drug. We can actually refer to the product insert. The drug I'm referring to is chenodiol, which was first approved in 1983, was approved at doses that are comparable to what we're planning to use, and side effects in general are described as minor and transient.

The intellectual property we've licensed from MIT is in the form of an exclusive license that covers the platform technology as well as initial product candidates. It's filed globally. And Bilayer as a company actually owns additional IP regarding the key polymorphs of sodium CDC, the active ingredient that are required to make a tablet.

Our development plan is shown here. We're actually looking for partnerships and collaborations with regard to the initial human clinical development of our approach. You can see that until the middle of 2025, we're planning to do the regulatory and CMC work to open the IND. We'll then do our first clinical trial in the form of a phase 1 PK study, and then we'll be doing individual phase 2a trials for the different indications we are targeting.

And in sum, that's what we're doing, and I'm looking forward to your questions.

ARIADNA RODENSTEIN: Thank you, Thomas. Thanks so much. Again, please post questions to the Q&A tab, and we'll include them for each startup. So you touched on this a little bit, but how long do you expect patients to have to take BL050 for obesity, and how does it work once you reach possibly the target?

THOMAS A. COLLET: Yeah, so basically with these drugs in general, everything that's in development or known right now requires lifelong therapy. So you basically will start on the therapy. You will lose weight, and then you have to continue the therapy to maintain the weight loss. This makes it very similar to statins, which you take lifelong to manage cholesterol levels or hypertension drugs. Commercially speaking, of course, that's attractive because chronic treatment is ongoing revenues as opposed to a cure, where you have to figure out how you get paid for one-time treatment.

And I'm sorry. The second part of the question was?

ARIADNA RODENSTEIN: Well, no, you touched on it. How does it work versus continuing for lifelong progress?

THOMAS A. COLLET: Yeah, I think that this is really the strength of our approach because the side effects are so benign, it is actually conceivable that you can take them lifelong and have a reasonable quality of life when it comes to GI comfort.

ARIADNA RODENSTEIN: Thank you. And those drugs like Ozempic and others, pretty expensive. Do you expect this to be covered by insurance in the future?

THOMAS A. COLLET: Yeah, well, that's the big question. So for certain indications such as diabetes and chronic constipation, reimbursement should not be an issue because other drugs are reimbursed as well. When it comes to weight loss, there are now some insurance companies that are dropping coverage because of the expense, but the overall trend is towards increased coverage because the benefits of weight loss on overall health and cost are really quite compelling. It's not just weight loss. It's also better heart health, better cardiovascular outcomes, better kidney health, and so on and so forth. So the tendency is that this will be covered even by government programs in the US, such as Medicare and Medicaid.