Sensulin’s Biotech Dream Team Is Bringing the Lowest-Cost Smart Insulin to Market

The idea of glucose-responsive insulin has been bandied about for decades. Could a new insulin formulation automatically level out high and low glucose levels such that a person dependent on insulin only needed to take one shot a day? Now CEO Mike Moradi has assembled a team with the experience necessary to make this dream a reality — and at an accessible price point.

Investors, learn how you can become a Health Moonshot Champion and support Health Transformers like Mike Moradi of Sensulin.

Origin Story

Sensulin’s idea to create a “smart insulin” (glucose-responsive insulin or “GRI”) is not new. Three of the company’s co-founders were toying around with the idea in the 1990s and 2000s, and the concept has existed in academia for some time. What sets Sensulin apart is their dream team of diabetes researchers and the use of an already-approved insulin as the basis for its formulation, which will help bring glucose-responsive insulin to market.

Their team has a successful exit track record and a combined century of experience in diabetes research and biotechnology. Dan Bradbury, their Chairman & Founder, was the CEO of Amylin, which developed the first GLP-1 drugs. In 2012 Amylin was acquired by AstraZeneca and BMS for $7 billion, which is still the largest exit in the diabetes sector. Chris Rhodes, PhD, their CTO, was the CEO & Founder of Drug Delivery Experts, and as a newly minted post-doc he invented the Technosphere inhalable delivery system, which is the only non-injectable insulin approved by the FDA. He also worked at Amylin as the head of drug delivery for nearly a decade. Mike Moradi, CEO & Founder, co-founded Nanosource, a nanotechnology company acquired by Dupont.

In addition to their impressive professional accomplishments, the team has personal knowledge of the disease. Both of Moradi’s parents are insulin dependent. In his late 20s — when he noticed that a whole generation of his family was being diagnosed with Type 2 diabetes — he moved from working in advanced materials and semiconductors to the natural sciences, in hopes of having an impact on diabetes research. Jon Brilliant, Sensulin’s CFO, also has family members impacted by the disease. His youngest child was diagnosed with Type 1 diabetes, which has since become a professional area of focus, along with cancer and mental health. It’s in the intersection of mental health issues and diabetes that he feels Sensulin can make a profound difference.

The Challenge

People with Type 1 diabetes typically take insulin shots four to six times a day. “There’s an interplay between Type 1 diabetes and mental health,” says Brilliant. “There’s a cognitive burden one carries when diagnosed at nine years old and told there’s a drug that can save your life but if you don’t manage it properly it can also kill you or you can lose your leg by the time you’re 50. Think about the burden of that. You can never escape it.”

Insulin-dependent Type 2 diabetics take fewer insulin shots — usually one or two a day — but they also have to continuously monitor their blood sugar levels. “Living with chronic diabetes is a complex math problem,” says Moradi. Individuals must time their insulin injections with their meals and try to match up the peak PK curves of the insulin with their digestive curves. For the 537 million diabetes patients worldwide, it’s a process that involves a fair amount of guesswork, trial by error, and adjustments — and mistakes can be costly to one’s health.

If a person with diabetes spends too much time in hyperglycemia (marked by high levels of glucose in the bloodstream) long-term effects can arise, such as eye and kidney disease. Hypoglycemia can be deadly for patients and the average person with Type 1 diabetes goes to the ER once per year, which is half the cost of treating the disease, according to Moradi.

The Solution

Sensulin’s glucose-response insulin takes the guesswork out of diabetes management by meeting both baseline and mealtime needs with a single injection. Whereas a person with diabetes is always living between the peaks and valleys of hyperglycemia and hypoglycemia, Senuslin helps to calm these waves through its chemical makeup that can recognize imbalances in glucose levels and respond by either bringing blood sugar levels up or down. “This takes the guesswork out of a very complex disease,” says Moradi.

Brilliant sees Sensulin as an interim step toward a cure for the disease. “I don’t think there will be a cure in my daughter’s lifetime,” he says. “We don’t even know what causes Type 1 at this point and reprogramming the autoimmune system is not an easy journey,” he adds. But moving to one shot a day would be a big step forward. “I think there’s a continuum toward the cure and we’re playing an advancing role towards those next steps.” Moradi adds “Even in a world where a cure exists, the world still needs better and cheaper insulins.”

Reducing costs is another major motivating factor for Sensulin. “The innovations that will be truly game changing will be super low cost and widely available,” says Moradi. He hopes that Sensulin will be available worldwide and save patients considerable money. He adds, “There is always room in the market for the low-cost producer, though our real goal is to be best-in-class. If we are also first-in-class, that is the icing on the cake.”

How It Works

“Sensulin is sort of like a chemical pancreas,” says Moradi. “When blood sugar is high, it releases more insulin. When blood sugars return to normal, it releases less, much like a healthy human pancreas.” The solution is achieved by clever chemistry. “It’s a very elegant solution to a very complex problem,” says Brilliant.

Sensulin does not use chemically-modified insulin, which distinguishes it from other glucose responsive insulin. The company sees this as a significant advantage, which they anticipate will lead to a faster and cheaper FDA approval process and a lower price when it hits the market. Other GRIs are considered “New Chemical Entities” by the Food & Drug Administration and other regulatory bodies globally, which requires more stringent clinical trials with many more patients and longer timelines.

Ananth Annapragada, their chief scientist, first developed something that appeared to work in rats in his academic labs. The technology they initially licensed was inhalable insulin but the linker (sort of like a glue between the liposomes) was toxic. “Challenge number one was to take something that worked as an inhalable drug and repurpose that as a subcutaneous injectable,” says Moradi. This required a new route of administration and finding new linkers. This initial research was funded by the National Institutes of Health, the National Science Foundation, and private foundations and investment.

Where They Are in the Process

In 2021 the company raised a $4M Series A round of capital that helped them hit key research milestones. Currently, they are at a point of transition, moving from a research and development preclinical team to a clinical team. They are gearing up for another set of pig studies to show further scientific proof of concept in a large animal setting before moving to a human clinical setting. “The roadmap is there,” says Moradi. They are currently seeking further funding to bring them into this next stage of development.

Our Take

Sensulin’s ambition to reduce insulin injections to once-per-day would greatly improve the quality of life for patients. It promises to reduce hospitalization for hyperglycemia, lower the cost of treatment, and lighten the burden for people with diabetes through a smart insulin that can regulate glucose levels without the stress of hypervigilance. We’re hopeful about this cost-aware solution that could be widely accessible, and we’re honored to join this world-class team toward achieving this goal as a member of our T1D Moonshot Community.

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Published: Mar 8, 2024

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