Nemysis Ltd Announces Appointment of Antonino Santoro as Adviser for Scientific Affairs

Nemysis Ltd today announces the appointment of Antonino Santoro to its Executive Team as Adviser for Scientific Affairs.

Antonino Santoro is a Chemist, graduate of the University of Messina, Italy, with over 30 years of experience in Regulatory Affairs and a strong expertise in the development of Prescription and Nutraceutical products. He started his career as a researcher at the Mario Negri Pharmacological Institute in Milan in 1975, where he worked for four years in a team of toxicologists. After a stint as Head of the development Pharmagel S.p.A., where he developed different Food Supplements, he joined Rottapharm/Madaus – an R&D pharmaceutical company with commercial activities and diversified presence into the market with Medicinal Products, Food Supplements and Cosmetics – where he was responsible for Regulatory Affairs and Business Development at the corporate level and secured regulatory authorization of hundreds of medicinal products in over 60 countries.

He is a board member of Federsalus (Italian Association of Food Supplements) since 2005. In 2013 he was elected Vice-President of Federsalus, with the mandate to represent the Association in front of the European Institution and liaise with other European Associations and, as such, was elected in the board of EHPM, the European Federation of Associations of Health Product Manufacturers.

Currently, Antonino serves as a board member of Sifi S.p.A, Glycemicon AG and Difass International S.r.l.

“We are very honoured and privileged to have established this long-term collaboration with such an expert on Regulatory Affairs”, said Danilo Casadei-Massari, Chairman of the Board.  “Antonino’s depth of knowledge in regulatory affairs, as well as his leadership skills and problem-solving acumen, make him an incredible asset to Nemysis, at a time where the company is preparing to enter its commercial phase in Europe and Worldwide.”

Dr. Santoro stated: “I’m excited to join Nemysis at such a topical moment in its development, as it prepares to transform itself from a research-based start-up into a full-fledged biopharma company.”

About Nemysis:

NEMYSIS LTD, a healthcare and pharmaceutical company, is focused on nutritional and pharmaceutical solutions that can protect against some of the negative consequences of nutrient deficiency, nutrient intolerances and sensitivities, paying particular attention to the need to safeguard the human microbiome.

  • Nemysis’s novel nanoparticulate iron is the first natural ferritin mimic, which can correct human iron deficiency and anemia, without negatively impacting the gut microbiome. Safety and efficacy have been demonstrated in controlled-repeat-dose clinical trials.
  • Nemysis’s novel E40 endopeptidase is gastric, trypsin and chymotrypsin resistant. It has been shown to destroy all the immuno-stimulatory epitopes of gluten, quenching the exacerbated inflammatory response of primed, gluten-sensitive and hyper-responsive human T cells. It is, therefore, suitable for the enzymatic management of gluten intolerance and sensitivity.

www.nemysisltd.com

Danilo Casadei-Massari

Suite 4.01 Ormond Building

31-36 Ormond Quay Upper

Arran Quay D07 F6DC – Ireland +35315313450

casadei-massari@nemysisltd.com

Nemysis Ltd. Appoints Dr. David S. Sanders to Its Scientific Advisory Board

Nemysis Ltd. announced today the appointment of David S. Sanders, MD, to its Scientific Advisory Board (SAB).

David Sanders, MD, is a professor of Gastroenterology and a Consultant Gastroenterologist at the Royal Hallamshire Hospital & the University of Sheffield, UK, which was recently designated as the UK National Centre for Refractory Celiac Disease (2019) and a World Endoscopy Organisation GI Centre of Excellence (2020). He is the current Chair of the Celiac UK Health Advisory Council.

Internationally recognised for his work in Celiac Disease and gluten-related disorders, Dr. Sanders has over 400 peer-reviewed papers and has been the recipient of research awards such as the European Rising Star Award, the Cuthbertson Medal, the Swedish Gastroenterology Society Bengt Ihre Medal and most recently the British Society for Gastroenterology (BSG) Hopkins prize for Endoscopy.

“We are honoured to welcome Dr. Sanders on Nemysis’ Scientific Advisory Board”, said Danilo Casadei-Massari, Chairman and Chief Executive Officer of Nemysis Ltd. “As a world-renowned expert in Celiac Disease and Gluten Sensitivity, Dr. Sanders’ appointment comes at a perfect time, as we continue to advance the development of our E40 technology, aimed at managing Celiac Disease and Gluten Sensitivity”.

“We are excited to have David join Nemysis’ SAB. His clinical expertise in Celiac Disease and gluten intolerance will help us shaping the clinical development of E40”, said Maria Cristina Comelli, Chief Scientific Officer of Nemysis.

“Celiac Disease and gluten intolerance are rapidly becoming a major worldwide healthcare issue and breaking down gluten immunogenic fractions is key to addressing this challenge,” said Dr. Sanders. “I am looking forward to working with Nemysis to develop E40, its promising glutenase technology, which has the potential to prevent the symptoms and clinical consequences of gluten exposure in Celiac patients”.

About Nemysis:

Nemysis LTD, a healthcare and pharmaceutical company, is focused on nutritional and pharmaceutical solutions that can protect against some of the negative consequences of nutrient deficiency, nutrient intolerances and sensitivities, paying particular attention to the need to safeguard the human microbiome.

  • Nemysis’ novel E40 endopeptidase is gastric, trypsin and chymotrypsin resistant. It has been shown to destroy all the immuno-stimulatory epitopes of gluten, quenching the exacerbated inflammatory response of primed, gluten-sensitive and hyper-responsive human T cells. It is, therefore, suitable for the enzymatic management of gluten intolerance and sensitivity.
  • Nemysis’s novel nanoparticulate iron is the first natural ferritin mimic, which can correct human iron deficiency and anemia, without negatively impacting the gut microbiome. Safety and efficacy have been demonstrated in controlled repeat-dose clinical trials.

www.nemysisltd.com

Danilo Casadei Massari, Chairman of the Board

Nemysis Ltd – Suite 4.01 Ormond Building

31-36 Ormond Quay Upper Arran Quay

Dublin 7

Ireland

+35315313450

casadei-massari@nemysisltd.com

Dr. Alessio Fasano joins Nemysis Ltd’s Scientific Advisory Board

Nemysis Ltd announced today the appointment of Dr. Alessio Fasano to its Scientific Advisory Board (SAB).

Dr. Alessio Fasano

A pediatric gastroenterologist, Alessio Fasano, MD, is head of the Mucosal Immunology and Biology Research Center at Massachusetts General Hospital (MGH) and professor of nutrition at the Harvard T.H. Chan School of Public Health. In 2000, his group discovered zonulin, a protein that regulates intestinal tight junctions and is associated with gut dysbiosis. His basic research focuses on bacterial pathogenesis, gut microbiome composition and function in health and disease, the regulation of gut permeability, intestinal mucosal biology and immunology. He is director of the Center for Celiac Research and Treatment at MGH and widely sought after as an expert in celiac disease, intestinal permeability and autoimmune disorders. Dr. Fasano is the author of several research papers and books on celiac disease and non-celiac gluten sensitivity.

“We are delighted to welcome Dr. Fasano to our SAB. His vast and in-depth knowledge will be tremendously valuable as we move our pipeline of novel enzymatic therapy for gluten intolerance toward the clinical phases of development,” said Danilo Casadei Massari, Chairman and CEO of Nemysis Ltd.

“It is a pleasure to have Alessio serve on Nemysis’ scientific advisory board. His deep expertise in celiac disease and gluten intolerance will be instrumental as we pursue therapeutic opportunities in these areas,” said Maria Cristina Comelli, Chief Scientific Officer of Nemysis.

“There is substantial untapped potential to target celiac disease and non-celiac gluten sensitivity,” said Dr. Fasano. “I welcome the opportunity to work with Nemysis’ scientific leaders and SAB to bring new treatments to patients.”

About Nemysis:

Nemysis LTD, a healthcare and pharmaceutical company, is focused on nutritional and pharmaceutical solutions that can protect against some of the negative consequences of nutrient deficiency, nutrient intolerances and sensitivities, paying particular attention to the need to safeguard the human microbiome.

  • Nemysis’ novel E40 endopeptidase is gastric, trypsin and chymotrypsin resistant. It has been shown to destroy all the immuno-stimulatory epitopes of gluten, quenching the exacerbated inflammatory response of primed, gluten-sensitive and hyper-responsive human T cells. It is, therefore, suitable for the enzymatic management of gluten intolerance and sensitivity.
  • Nemesis’s novel nanoparticulate iron is the first natural ferritin mimic, which can correct human iron deficiency and anemia, without negatively impacting the gut microbiome. Safety and efficacy have been demonstrated in controlled-repeat-dose clinical trials.

www.nemysisltd.com

Danilo Casadei Massari, Chairman of the Board

Nemysis Ltd -Suite 4.01 Ormond Building-31-36 Ormond Quay Upper-Arran Quay, Dublin 7, D07 F6DC  +35315313450

casadei-massari@nemysisltd.com

Nemysis Limited Announces Grant of First Canadian Patent for E-40

  • Nemysis’s novel E40 endopeptidase is gastric, trypsin and chymotrypsin resistant. It has been shown to destroy all the immuno-stimulatory epitopes of gluten, quenching the exacerbated inflammatory response of primed, gluten-sensitive and hyper-responsive human T cells. It is, therefore, suitable for the enzymatic management of gluten intolerance and sensitivity.
  • Nemysis’s novel nanoparticulate iron is the first natural ferritin mimic, which can correct human iron deficiency and anemia, without negatively impacting the gut microbiome. Safety and efficacy have been demonstrated in controlled-repeat-dose clinical trials.

www.nemysisltd.com

Danilo Casadei-Massari
Chairman of the Board Nemysis Ltd
7 D’Olier Street, D02HF60, Dublin Ireland
+35315313450
casadei-massari@nemysisltd.com

Nemysis Ltd Announces Grant of First Chinese Patent for IHAT, the Novel Iron Nanoparticulate Supplement for Iron Deficiency (ID) and Iron Deficiency With Anemia (IDA).

Dublin, May 12th, 2021– Nemysis Ltd. today announced the issuance of China Patent Number 201680058940.3 titled “Methods for producing carboxylate ligand modified ferric iron hydroxide colloids and related compositions and uses”. This is the first patent issued to Nemysis in China in the field of oral iron supplementation in conditions of ID and IDA. The patent claims describe methods for producing IHAT (Iron Hydroxide Adipate Tartrate), where Generally Recognised As Safe (GRAS) organic acids, and particularly Tartaric and Adipic acids, are used to modify the ferrihydrite nanocore of ferritin – the dietary and iron storage form of iron – increasing iron availability upon increased iron demand by the body.

IHAT is well absorbed by endocytosis exclusively into duodenal enterocytes, does not release free iron on the intestinal lining and, as such, does not exert a negative impact on the gut, as per most oral iron supplementation products currently available on the market. Absorption studies and nutritional trials in humans demonstrate IHAT to be efficiently absorbed and to correct markers of ID and IDA, with no burden of gastrointestinal side effects and no disruption of the gut microbiome.

Danilo Casadei-Massari, Chairman and CEO of Nemysis Ltd commented, “We are particularly excited about the grant of this Patent. This patent further supports our ongoing R&D efforts in treating a worldwide highly prevalent condition such as ID and IDA, with a product representing the crest of the wave of innovation in the field of iron supplementation.

Marco Cartolari, COO of Nemysis Ltd added “The Grant of our first China Patent is a great moment for Nemysis. We are excited to bring IHAT and help those who are affected by iron deficiency in China.  Receipt of this patent reflects our continued focus on innovation while strengthening our international intellectual property portfolio, and covers a product that we believe has significant market potential.”

 

About Nemysis:

NEMYSIS LTD, healthcare and pharmaceutical company focused on nutritional and pharmaceutical solutions that can protect against some of the negative consequences of nutrient deficiency, nutrient intolerances and sensitivities, paying particular attention to the need to safeguard the human microbiome.

Nemysis’s novel nanoparticulate iron is the first natural ferritin mimic, which can correct human iron deficiency and anemia, without negatively impacting the gut microbiome. Safety and efficacy have been demonstrated in controlled-repeat-dose clinical trials.

Nemysis’s novel E40 endopeptidase is gastric, trypsin and chymotrypsin resistant. It has been shown to destroy all the immuno-stimulatory epitopes of gluten, quenching the exacerbated inflammatory response of primed, gluten-sensitive and hyper-responsive human T cells. It is, therefore, suitable for the enzymatic management of gluten intolerance and sensitivity.

 

www.nemysisltd.com

Danilo Casadei-Massari

Chairman of the Board

Nemysis Ltd

7 D’Olier Street

D02HF60 Dublin

Ireland

+35315313450

casadei-massari@nemysisltd.com

 

Nemysis Ltd Announces Appointment of Dr. Margit Holzer to Its Scientific Advisory Board

Nemysis Ltd announced today the appointment of Dr. Margit Holzer to its Scientific Advisory Board (SAB).

Dr. Margit Holzer, Scientific Director at Ulysse-Consult Sarl, is a passionate biochemical engineer with internationally recognized expertise in development, industrialization and implementation of biotechnological production processes, in the field of pharma and food applications.

Holzer holds a master’s and a PhD in biotechnology from the University of Natural Resources and Applied Life Sciences in Vienna (Austria) and has worked internationally for Boehringer-Ingelheim and Novasep, holding various executive positions in R&D, production, quality, technology and business worldwide.

“We are pleased to have Margit join our SAB as we are striving to industrialize the production process of our products,” said Maria Cristina Comelli, Chief Scientific Officer and Chair of the SAB. “We look forward to her contribution as we approach the next phase of our company’s growth.”

“I am honoured to join Nemysis as we strive to advance the quality of care available to patients with gluten intolerance,” added Dr. Holzer. “Nemysis is well-positioned to positively impact the lives of CD and NCGS patients through the development of E40.”

“I am personally very pleased to welcome Dr. Holzer as an advisor to Nemysis,” said Marco Cartolari, Chief Operating Officer of Nemysis. “Margit brings considerable expertise in biotechnology manufacturing process development, and we believe she will make an invaluable contribution to our product development program”.

About Nemysis:

Nemysis LTD, a healthcare and pharmaceutical company, is focused on nutritional and pharmaceutical solutions that can protect against some of the negative consequences of nutrient deficiency, nutrient intolerances and sensitivities, paying particular attention to the need to safeguard the human microbiome.

  • Nemysis’s novel E40 endopeptidase is gastric, trypsin and chymotrypsin resistant. It has been shown to destroy all the immuno-stimulatory epitopes of gluten, quenching the exacerbated inflammatory response of primed, gluten-sensitive and hyper-responsive human T cells. It is, therefore, suitable for the enzymatic management of gluten intolerance and sensitivity.
  • Nemysis’s novel nanoparticulate iron is the first natural ferritin mimic, which can correct human iron deficiency and anemia, without negatively impacting the gut microbiome. Safety and efficacy have been demonstrated in controlled-repeat-dose clinical trials.

www.nemysisltd.com

Danilo Casadei-Massari, Chairman of the Board

Nemysis Ltd – 7 D’Olier Street- D02HF60 Dublin – Ireland +35315313450

casadei-massari@nemysisltd.com

Nemysis Ltd Strengthens Its Scientific Advisory Board With Nutritional and Pharmaceutical Solutions Expert Linda Cavaletti

Nemysis Ltd today announces the appointment of internationally recognized drug discovery and development expert Linda Cavaletti to its Scientific Advisory Board (SAB).

Since its inception, Nemysis has initiated and developed high-value innovative R&D programs, including one targeting Celiac Disease and Non-Celiac Gluten intolerance, with the aim of bringing novel treatments to patients suffering from these conditions.

Linda Cavaletti, Senior Associate Scientist at Fondazione Istituto Insubrico di Ricerca per la Vita (FIIRV), is a biologist with long expertise in isolation and cultivation of strains for natural products discovery, culminating in a project for identification of a new glutenase by acidophilic actinomycete strains. Since then, she is the leader of the Celiac Disease project in FIIRV, which led to discovery of E40, its patenting in 2012, and the collaboration with Nemysis.

“I am delighted to join Nemysis’s board of Scientific Advisors and eager to contribute to Nemysis’ corporate development efforts to realize its vision on E40,” said Linda Cavaletti. “I believe the company’s prospects are excellent. I look forward to working with the team over the coming years to build a broad-based, world-class company.”

“We are very honoured and privileged to have established this long-term collaboration with such an expert on enzyme development, who we are sure will be a valuable asset to Nemysis and to those who suffer from gluten intolerance,” said Maria Cristina Comelli, chair of the SAB. “We are excited about working closely with her, as we approach the next phase of our company’s growth.”

“I am personally very pleased to welcome such an outstanding scientist as an advisor to Nemysis,” said Danilo Casadei-Massari, Chairman of the Board. “No doubt Linda Cavaletti’s expertise will contribute to increasing the value of Nemysis’s current and future assets.”

About Nemysis:

NEMYSIS LTD, a healthcare and pharmaceutical company, is focused on nutritional and pharmaceutical solutions that can protect against some of the negative consequences of nutrient deficiency, nutrient intolerances and sensitivities, paying particular attention to the need to safeguard the human microbiome.

  • Nemysis’s novel nanoparticulate iron is the first natural ferritin mimic, which can correct human iron deficiency and anemia, without negatively impacting the gut microbiome. Safety and efficacy have been demonstrated in controlled-repeat-dose clinical trials.
  • Nemysis’s novel E40 endopeptidase is gastric, trypsin and chymotrypsin resistant. It has been shown to destroy all the immuno-stimulatory epitopes of gluten, quenching the exacerbated inflammatory response of primed, gluten-sensitive and hyper-responsive human T cells. It is, therefore, suitable for the enzymatic management of gluten intolerance and sensitivity.

www.nemysisltd.com

Danilo Casadei-Massari, Chairman of the Board

Nemysis Ltd – 7 D’Olier Street- D02HF60 Dublin – Ireland +35315313450

casadei-massari@nemysisltd.com

Nemysis Ltd Establishes a New Subsidiary in the U.S.

Nemysis Limited, the Dublin based pharmaceutical and healthcare Company, focused on Iron Deficiency/Anemia and Gluten Sensitivity, announced today the establishment and commencement of operations of Enteralia Bioscience LLC, the Company’s new pharmaceutical R&D subsidiary in The United States of America.

The opening of this subsidiary is a first step in the company’s strategy to expand its activities in the US, with the aim to support the Research & Development and business development activities of E40 – its celiac Disease and Gluten Intolerance lead compound – and establish partnerships with leading academic institutions, pharmaceutical companies and investors in the U.S.

Danilo Casadei-Massari, Chairman and CEO of Nemsysis Ltd commented: “We are delighted with the opening of this new subsidiary in The United States of America, the largest pharmaceutical market in the world. We will bring innovative treatments to patients with nutritional deficiencies, and serve our existing and future principals in the best possible way. The opening of our new subsidiary in The United States gives us the opportunity to better help those who are affected by Celiac Disease and Non-Celiac Gluten Intolerance, by working on the further development of E40.”

Marco Cartolari, COO of Nemsysis added: “ We will soon announce the names of new Directors to have in place an experienced and qualified team at  Enteralia Bioscience which will be located in the Boston area,  home to one of the most advanced scientific and medical communities. We are thrilled to be able to tap into their knowledge and expertise to develop E40 and help those affected by Celiac Disease and Non-Celiac Gluten intolerance, conditions for which no effective treatment option is currently available.”

About Nemysis:

NEMYSIS LTD, a healthcare and pharmaceutical company, is focused on nutritional and pharmaceutical solutions that can protect against some of the negative consequences of nutrient deficiency, nutrient intolerances and sensitivities, paying particular attention to the need to safeguard the human microbiome.

  • Nemysis’s novel E40 endopeptidase is gastric, trypsin and chymotrypsin resistant. It has been shown to destroy all the immuno-stimulatory epitopes of gluten, quenching the exacerbated inflammatory response of primed, gluten-sensitive and hyper-responsive human T cells. It is, therefore, suitable for the enzymatic management of gluten intolerance and sensitivity.
  • Nemysis’s novel nanoparticulate iron is the first natural ferritin mimic, which can correct human iron deficiency and anemia, without negatively impacting the gut microbiome. Safety and efficacy have been demonstrated in controlled-repeat-dose clinical trials.

www.nemysisltd.com

Danilo Casadei-Massari
Chairman of the Board
Nemysis Ltd
7 D’Olier Street
D02HF60 Dublin
Ireland
+35315313450
casadei-massari@nemysisltd.com

Nemysis Granted Patent on Its Nano-Particulate Oral Iron Product (IHAT) in South Africa

Nemysis Limited, the Dublin based pharmaceutical and healthcare company, focused on Iron Deficiency/Anemia and Gluten Sensitivity, today announced that the South Africa Patent and Trademark Office has issued S.A. Patent No.ZA201802192, with claims of Methods for Producing Carboxylate Ligand Modified Ferric Iron Hydroxide Colloids and Related Compositions and Uses, directed to the use of oral iron supplementation.

“This is an advancement in our efforts to broaden our global patent estate for IHAT,” said Danilo Casadei-Massari, Chairman and Chief Executive Officer of Nemysis. “To date, our intellectual property portfolio spans multiple patents and patent applications in the U.S., EU, and numerous additional countries.”

Currently, the research-based company, Nemysis has several patents approved and filed in the U.S., EU and other countries around the world, related to its IHAT, novel oral iron formulation, to support the company’s effort to establish and protect a global commercial footprint in the near future.

About Nemysis:

NEMYSIS LTD, a healthcare and pharmaceutical company, is focused on nutritional and pharmaceutical solutions that can protect against some of the negative consequences of nutrient deficiency, nutrient intolerances and sensitivities, paying particular attention to the need to safeguard the human microbiome.

Nemysis’s novel nanoparticulate iron is the first natural ferritin mimic, which can correct human iron deficiency and anemia, without negatively impacting the gut microbiome. Safety and efficacy have been demonstrated in controlled-repeat-dose clinical trials.

Nemysis’s novel E40 endopeptidase is gastric, trypsin and chymotrypsin resistant. It has been shown to destroy all the immuno-stimulatory epitopes of gluten, quenching the exacerbated inflammatory response of primed, gluten-sensitive and hyper-responsive human T cells. It is, therefore, suitable for the enzymatic management of gluten intolerance and sensitivity.

www.nemysisltd.com

Danilo Casadei-Massari

Chairman of the Board

Nemysis Ltd

7 D’Olier Street

D02HF60 Dublin

Ireland

+35315313450

casadei-massari@nemysisltd.com

Antonio Maggi Joins Nemysis Ltd Board of Directors

Antonio Maggi, Senior Executive, specializing in marketing and sales network management, has over 30 years of experience in various industries. Over the last 25 years, his experience has focused on the pharmaceutical sector with expertise in the development of start-up companies for which he has defined their long-term strategies and planned all pre- and post-marketing activities.

Antonio has also held academic positions for over ten years as a university professor dealing with market policies related to health and the drug market.

“Antonio will add significant value as a Nemysis board member, drawing on his experience and professional network, particularly as we are preparing our first commercial presence in the European market. We look forward to benefiting from his expertise as we continue to grow the company,” said Marco Cartolari, Co-Founder and Director.

Antonio stated: “Joining the Board of Directors is a privilege for me. I enthusiastically welcomed the proposal to join Nemysis, a company that from the very first moment impressed me for its dynamism, for the innovation of its projects and for the spirit that animates its members. Contributing to the achievement of the ambitious goals of the company makes me proud, and it will be exciting to work towards future success with all my colleagues.”

Antonio has a Master Degree in Economics from Politecnico delle Marche University.

About Nemysis:

Nemysis Ltd, a healthcare and pharmaceutical company, is focussed on nutritional and pharmaceutical solutions which can protect against some of the negative consequences of nutrient deficiency, nutrient intolerances and sensitivities, paying particular attention to the need to safeguard the human microbiome.

  •  Nemysis’s novel nanoparticulate iron is the first natural ferritin mimic, which can correct human iron deficiency and anemia, without negatively impacting the gut microbiome. Safety and efficacy have been demonstrated in controlled-repeat-dose clinical trials. ​
  • Nemysis’s novel E40 endopeptidase is gastric, trypsin and chymotrypsin resistant. It has been shown to destroy all the immuno-stimulatory epitopes of gluten, quenching the exacerbated inflammatory response of primed, gluten-sensitive and hyper-responsive human T cells. It is, therefore, suitable for the enzymatic management of gluten intolerance and sensitivity. ​​

Nemysis has three further products in its pipeline for use in Iron Deficiency/Anaemia, Gluten sensitivity and Celiac Disease.

Read more www.nemysisltd.com

Danilo Casadei -Massari​
Chairman of the Board
​Nemysis Ltd
7 D’Olier Street
D02HF60 Dublin
Ireland
+35315313450
casadei-massari@nemysisltd.com