Levicure Is Developing a Breakthrough Triple Therapy for Type 1 Diabetes
Shmuel Levit, MD, PhD, has developed a therapy for Type 1 diabetes (T1D) that could revolutionize diabetes treatment. Combining proven and safe drug components, Levicure offers the possibility of remission and improved quality of life for people with T1D. Driven by the remarkable results observed in early patient trials and backed by rigorous research and with a focus on scalability, safety, and affordability, Levicure aims to bring relief to millions of people living with T1D.
Investors, learn how you can back Health Transformers like Daniil Koshelev, Lucy Kosheleva, and Shmuel Levit, MD, PhD.
The Challenge
It’s been a hundred years since researchers discovered insulin, forever changing the lives of people living with Type 1 diabetes (T1D). Since then, there’s been a steady flow of innovations in the diabetes space, refining the process of insulin monitoring and delivery modes so that patients get the insulin their bodies need. With insulin, the prognosis of T1D changed from an early death to a manageable chronic disease.
At the end of the day, though, insulin is just that–something to manage the disease, not a cure. 100 years later, researchers are still looking for that magic bullet that will actually halt or reverse diabetes, with investors and pharmaceutical companies throwing massive amounts of money behind novel molecular and cell-based interventions. However, diabetes, like other autoimmune disorders, is incredibly complex, involving multiple pathological processes within the body. The likelihood a single molecule addresses the many systems at play is slim.
That’s why diabetes researchers like Alex Rabinovitch, MD, PhD, have spent decades looking into compound drugs that tackle different disease mechanisms simultaneously. Dr. Rabinovitch specifically found that a combination of proton-pump inhibitors (PPIs) and an enzyme inhibitor known as DPP-4i proved effective at restoring pancreatic beta cells, the cells that synthesize, store, and release insulin, which were safely and effectively used in the market for other indications. These results are a big deal, especially considering both drugs have well-established safety records, making the combination low risk. Unfortunately, the combination of the two drugs together was not enough to show significant improvement in a clinical trial.
No One Believed Him
Shmuel Levit, MD, PhD, Head of Endocrinology and the Diabetes & Metabolism Institute at Assuta Medical Centers in Israel, knew all about Dr. Rabinovitch’s research into combination therapies. He was a big believer in their efficacy. Dr. Levit also closely followed the research around the efficacy of GABA, a neurotransmitter widely available as an over-the-counter supplement. In studies, GABA improved function of islet cells involved in producing insulin, delaying diabetes onset and helping restore normal blood glucose levels in animal models.
Because of the established safety of PPI, DPP-4i, and GABA, Dr. Levit felt emboldened to take action: he suggested a course of treatment to his patients with T1D that combined all three elements. He expected this plan would reduce insulin demand. What he didn’t foresee or imagine was that some of his patients would get off insulin completely. Dr. Levit was flabbergasted. The triple combination promoted full remission for 70% of his patients that were newly diagnosed with T1D and significantly reduced insulin needs for his patients who’d lived with the disease for years.
Ironically, without animal model studies and scientific peer-reviewed publications to back up what Dr. Levit saw with his patients, no one believed him. No one, that is, except Daniil Koshelev and Lucy Kosheleva, a husband and wife team with combined legal, research, and executive experience in the biotech space. They knew Dr. Levit through a personal connection–he treated and cured a close relative with a severe endocrine disorder–and they trusted his experience. Moreover, Dr. Levit’s discovery offered exactly what the Koshelevs were looking for–the chance to work on something big, something that could make a tremendous difference in patients’ lives around the world.
Dr. Levit and the Koshelevs embarked on an unusual journey to prove the results Levit observed in his patients, working backwards from the typical cells-to-animal-to-patients model of new drug testing. With the support of Professor Helgi Schioth from Uppsala University and Dr. Rabinovitch, who came on board as a scientific advisor, a large study on NOD mice was conducted and published. This research confirmed that the synergistic effect of the triple combination was significantly superior to all double-combination results in a comprehensive animal model of T1D. This study was fundamental for successfully obtaining USA and European patents.
To solidify Dr. Levit’s findings in his patients with T1D, the team together with Assuta Medical Centers received Helsinki’s approval to review existing medical records of treated individuals. It was important to unequivocally establish that patients had T1D and to carefully analyze all available data to establish the concrete therapeutic effect of the triple combination. The study was successfully published in a peer-reviewed journal and uncovered that 70% of people with T1D that were treated within 12 months of diagnosis experienced full insulin independence and a staggering C-peptide growth of 145%. While patients with long-term Type 1 diabetes also experienced improvement in glycemic control and decrease in exogenous insulin demand, it was really the early diagnosed group that showed such an unexpected result.
The fact that all three components are considered extremely safe can substantially speed up the development process of bringing the novel combination to market. Just three years after hearing about Dr. Levit’s very promising patient results, the team has recently received positive and helpful feedback from the FDA and is ready to proceed directly to phase 2a clinical trials without needing to do any prior human or even animal safety studies.
Meet Levicure
Levicure’s triple therapy is a proprietary combination drug entering phase 2 clinical development that will provide people with T1D a single tablet to facilitate remission, avoid T1D complications, and significantly improve their quality of life. Levicure combines safe and readily available drug components to create a scalable and affordable solution for the millions of people worldwide living with T1D. They have already successfully proved the concept with patients and received patents for their triple combination in US and Europe with additional IP protection in the form of exclusivities.
“We see ourselves as taking the first step on the moon because so far there is no product for people diagnosed with T1D that can offer sustainable remission. This combination could be the first step on the long way towards curing the disease, which will also change the way others look at combination therapies for complex diseases,” Koshelev says.
Besides the evidence that the Levicure triple combo therapy promotes full remission in adults recently diagnosed with T1D, its scalability and safety make the case for the product’s ability to penetrate the large diabetes market. Other diabetes solutions like cell therapies, transplants, stem cells, and immunotherapy come with high price tags, risks, scalability challenges, and high demands on a patient’s time and energy. Levicure aims to deliver a single tablet, taken once a day, to optimize compliance and adherence.
Levicure is fundraising to finalize their phase 2 program and develop the final version of the triple combination drug. Assuming all goes well, they hope to bring their product to market as soon as 2029. To that end, they’ve assembled a stellar management team to guide them through the process, including Mike Teiler as their Chief Pharmaceutical Officer; Dr. Yafit Stark as their Head of Clinical Development; and Dr. Alexander Fleming, formerly responsible for diabetes therapies at FDA, T1D expert, and founder of Kinexum, serving as a regulatory advisor. It’s a difficult process, but the co-founders find overcoming the challenges part of the joy of their work.
“This is the most challenging thing I’ve ever encountered. No one has ever conquered it,” Daniil says with the enthusiasm of a mountain climber. “Seeing Dr. Levit actually help his patients was the push moment for me,” adds Lucy. “He was brave enough not to stick to the book and bring this solution to people, and we want to get it out there for everyone else.”
Our Take
Levicure offers impressive results in a safe, scalable package, making it a diabetes intervention to watch. Because they repurpose and reformulate existing drugs to achieve these results, they can come to market much faster than novel molecules in development. With passionate founders at the helm, we see Levicure as having the grit and resources to shepherd their product to market, offering a viable path to remission for many people with diabetes.
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Published: Oct 26, 2023