Fractyl Laboratories secured $55 million for a Series E financing to continue funding a pivotal clinical trial of its potential non-drug, non-surgical treatment for Type 2 diabetes, according to the company.
The capital will go toward the Lexington, Mass-based start up’s Revita T2Di pivotal clinical trial of Revita DMR (duodenal mucosal resurfacing). Revita is measuring the effect of Fractyl’s Revita DMR treatment on glycemic control and insulin requirements.
The Revita DMR uses heat to ablate the surface lining of the upper intestine (duodenal mucosa) to reset key metabolic pathways, including insulin resistance, and reverse metabolic disease.
New investor Taiwania Capital Management Corporation led the round which included returning investors Bessemer Venture Partners, General Catalyst, Domain Associates, Mithril Capital Management, Emergent Medical Partners, True Ventures, and GV. The round drew first-time commitments from Catalio Capital Management, CDIB Venture Capital Corp., and YJ Capital.
“Type 2 diabetes and NAFLD/NASH are eroding our global health and are responsible for a large portion of global healthcare costs,” said Michael Huang, managing partner at Taiwania, who will join Fractyl’s board. “Fractyl has established through rigorous clinical studies that Revita, a breakthrough non-drug, non-surgical treatment, has the potential to significantly improve type 2 diabetes outcomes.”
In the release, Fractyl said the primary endpoint of the study will be the percentage of patients who are able to achieve target glycemic control (which is measured as HbA1c less than or equal to 7%) without the need for insulin at 24 weeks post-procedure. The treatment arm will be compared to a sham arm. Secondary endpoints will assess the impact of Revita DMR on additional glycemic, hepatic, and cardiovascular endpoints.
“Fractyl’s founding mission was to find a better way to treat Type 2 diabetes by addressing the root cause of disease that can reverse the disease process rather than manage its symptoms. We now have data from hundreds of patients with Type 2 diabetes showing the durable benefits of a single Revita treatment,” said Harith Rajagopalan, M.D., Ph.D., co-founder and CEO of Fractyl. “We welcome our new investors and the continued support of our returning investors, who recognize that we are at a pivotal moment in fundamentally redefining the treatment paradigm for metabolic diseases, including Type 2 diabetes and NAFLD/NASH. We look forward to initiating our pivotal U.S. clinical trial later this year.”
The company reported positive results from the trial last year.
Fractyl’s clinical studies have involved close to 300 patients at more than 20 centers worldwide. The companies secured CE Mark for Revita DMR in 2016. The CE Mark label was expanded form its original label to include patients with poorly controlled Type 2 diabetes on oral medications to include insulin withdrawal for patients with T2D.