Nemysis Limited Announces Successful IHAT-Gut Trial
DUBLIN, February 11, 2023 (Newswire.com) - Nemysis is pleased to announce the publication of the successful findings from the IHAT-Gut trial in iron-deficient anaemic patients (NCT02941081) in the premiere Lancet journal eClinicalMedicine https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00030-5/fulltext.
In this Phase II trial, Nemysis' novel oral iron supplement IHAT (Iron Hydroxide Adipate Tartrate) was compared to both ferrous sulphate (FeSO4), the current gold standard iron supplement, and a placebo. Iron-deficient anaemic, malnourished children aged 6-35 months were supplemented with either placebo, FeSO4 or IHAT for 85 days. IHAT was effective in resolving iron deficiency anaemia in 28.2% of children vs 1.1% in placebo and 22.1% in FeSO4 and showed higher tolerability than FeSO4, with a reduced incidence of moderate-severe diarrhea compared to FeSO4.
Dr. Cristina Comelli, R&D Director at Nemysis, remarks: "We are delighted about the publication of the trial results. IHAT is an engineered novel nanoFe(III), specifically developed to mimic the absorption and delivery of iron as per its natural physiological storage form, ferritin. The evidence confirms IHAT's high tolerability and improved safety profile compared to iron salts, the most widely used oral iron supplements. IHAT supplementation can provide a huge relief for all those who have suffered from side effects with the currently available iron supplements."
Danilo Casadei-Massari, Nemysis' Chairman and CEO, states: "We are excited by the continued success of IHAT as a leading therapy for people suffering from iron deficiency. Our mission is to develop innovative therapeutic solutions to address the impacts of nutritional disorders and deficiencies. With the success of this clinical trial, we are one step closer to providing an improved route to recovery from iron deficiency and its associated anaemia."
About iron deficiency
Iron deficiency and iron deficiency anaemia are the most widespread nutritional deficiency, affecting ~1.2 billion people globally, and are associated with a slew of symptoms, including tiredness, lack of energy and shortness of breath and, in more severe cases, an increased risk of serious morbidity and impaired immunity.
IHAT is a nanoparticulate ferric iron supplement that respects the physiology of natural iron. It was developed as an analogue of dietary ferritin, the natural iron storage protein, and follows its route of absorption. Like ferritin, IHAT is absorbed as whole nanoparticles in the intestine and does not release 'free' iron, a highly redox reactive form of iron and the culprit of the gastrointestinal side effects seen with conventional oral iron supplements. IHAT is efficacious and well-tolerated, with no negative impact on the gut microbiome.
Nemysis Limited provides therapeutic solutions to protect against adverse consequences of nutritional deficiency, intolerance and sensitivity, paying particular attention to the need to safeguard the intestinal microbiome.
Source: Nemysis ltd