DUBLIN, November 7, 2023 (Newswire.com) – Nemysis is pleased to announce receipt of grant funding under the European Horizon program, to advance the development of its E40 glutenase to Market Authorization for the management of gluten intolerance (celiac disease) and sensitivity.
Following the company’s successful application, the EIC has awarded the maximum grant amount of €2.5m to fund the completion of research & development to Market Authorization of Nemysis’ novel Endoprotease 40 for the prevention of symptomatic gluten exposure in gluten intolerance and sensitivity. Also, through the “grant first” award, the company has the option to partner with the EIC for €6m of equity funding (matched by additional private investments), on terms to be agreed, to accelerate the commercialization of E40.
Dr. Cristina Comelli, R&D Director at Nemysis, commented, “We are thrilled to receive the EIC’s backing for our R&D strategy, aimed at introducing the inaugural product for celiac disease and gluten sensitivity to the market. This grant, together with additional resources, provides the financial means required to successfully conclude our development program, including toxicology studies and clinical trials, to secure E40’s approval as a Class IIb Medical Device, in Europe. Moreover, data generated from this program will play a key role in supporting E40’s regulatory pathway in the United States.”
Danilo Casadei-Massari, Chairman and CEO of Nemysis, remarks, “This award signifies the acknowledgement of Nemysis’ important contributions in addressing widespread unmet needs, extending beyond Europe. We eagerly look forward to advancing E40’s journey to market, courtesy of this grant, and the possibility for follow-on EIC equity funding to accelerate the global commercialization of E40.”
About gluten intolerance and sensitivity
Gluten intolerance (celiac disease) affects 1.4% of the global population, while gluten sensitivity, known as non-celiac gluten sensitivity, impacts approximately 7%. Both conditions manifest with a range of distressing symptoms, including diarrhea, fatigue, malabsorption, severe gastrointestinal issues, and a significant decline in quality of life. Currently, the sole management available is a challenging lifelong compliance with a Gluten-Free Diet. It’s noteworthy that as many as 30% of patients are unable to tolerate gluten levels even below the limit of 20 ppm of the GFD. Furthermore, 50% of calories in the Western diet derive from gluten-containing wheat, making inadvertent exposure commonplace. Therefore, the development of an effective complement to the Gluten-Free Diet, such as E40, addresses a crucial and widespread unmet need.
E40 is a recombinant protein for the degradation of gluten and its immunogenic peptides. It possesses all the required attributes to be an effective oral enzymatic therapy and act as a first-line treatment, whilst also demonstrating excellent safety, in particular, as it is not systemically absorbed. Taken before a meal, E40 has already been shown in the INFOGEST model to destroy gluten below the GFD threshold, preventing symptomatic exposure and abating the associated immune response. As a medical device, E40 will be price-competitive and accessible, not requiring a medical prescription.