GoodGut has moved to a new space at Science and Technology Park of Girona: equipped with the latest technology, such as class II biosafety cabinets, it makes for easier interaction among the team of scientists and business development professionals.
This change comes at a key moment for the biotechnology company, which is getting ready to present the clinical results of its pipeline of non-invasive systems for improving early diagnosis of colon cancer, Crohn’s disease and ulcerative colitis, among other inflammatory bowel diseases (IBD). GoodGut is aiming to have these products on the market by 2019.
GoodGut was created in 2014 as a spin-off of University of Girona and Biomedical Research Institute of Girona Dr Josep Trueta by Mariona Serra, Xavier Aldeguer and Jesús Garcia-Gil. “It is very important to us to work in a scientific and business environment in a city as attractive as Girona and be at the heart of an internationally-recognised life sciences cluster like the BioRegion of Catalonia” says Mariona Serra, CEO of the company. Today there are over 140 companies, research groups and institutions based at the UdG Park.
Digestive diseases have a high incidence rate and have a chronic and serious impact on the daily life of sufferers. GoodGut has just launched a new website (www.goodgut.eu), with the slogan Enhancing Digestive Health, on which it presents its pipeline of non-invasive and prebiotic systems for improving the diagnosis and treatment of conditions including colon cancer, Crohn’s disease, and ulcerative colitis. These products are in the clinical trial phase, with plans for them tol be put on the market in 2019.
This intuitive new website provides the user with full corporate information: the company; mission, vision and values; Management and Board of Advisers; strategic and scientific partners; social responsibility, and a page dedicated to careers.
Innovation based on intestinal microbiota
GoodGut’s know-how is based on the study of the intestinal microbiota of individuals, a determining factor in the immune system of the intestine and the development of digestive diseases. The company offers pioneering technological solutions for obtaining a faster, more reliable and cheaper medical diagnosis than using existing methods, and treatments to improve the quality of life of patients with compromised digestive health.
GoodGut was created in 2014 as a spin-off of University of Girona and Biomedical Research Institute of Girona Dr Josep Trueta by Mariona Serra, Xavier Aldeguer and Jesús Garcia-Gil. The company is based in the Science and Technology Park of Girona and forms part of CataloniaBio, the Catalan association of health and life sciences companies.
Today is the World Inflammatory Bowel Diseases’ Day, a group of chronic disorders of unknown origin which affects the gastrointestinal tract of more than 2,500,000 people in Europe. In Spain, there are between 150 and 250 cases every 100,000 inhabitants, of all of them the most common are the Crohn’s disease and the ulcerative colitis. In this post we will focus on the first.
The Crohn disease causes the inflammation of a segment of the intestines, it can affect any part of the digestive tract, but the small intestine last section, also known as ileum, is the most frequent area affected. There is a scientific consensus in that it is an autoimmune illness, but its causes are unknown. Scientists have isolated some risk factors: the main of them is a genetic component (a 20% of the patients have a relative with it), the other factors are: contamination, smoking habits and stress.
Chron’s main symptoms are frequent intestinal movement, diarrhoea and abdominal pain. Other indicators are joint pain, eye or mouth swelling and skin injuries. As a result of the affected intestines’ limited nutritional absorption capabilities some of the patients become anaemic, lose weight or experience fatigue. The illness alternates active phases with low-intensity ones which makes its symptomatology varied and unpredictable. However it is usual that the active periods produce fissures, fistulas and ulcers.
Crohn affects both sexes equally and normally develops in the youth (most cases are diagnosed between ages 15 -35). As a result of its genetic component, it is more prevalent in some ethnic groups, for example, in western Europe the incidence rate is the 6.3 cases every 100,000 inhabitants while in eastern Europe is the 3,3, according to the US National Library of Medicine National Institutes of Health.
The current treatments are not designed to cure it, only to diminish the symptoms and prolong the inactive periods. The most common medicines used are the corticosteroides and the aminosalicylates. If they are not effective, the doctors will prescribe immunomodulators and some biologic therapy. There is not an established method and the treatment is adapted to each person. In the most extreme cases, the patients are operated to repair or extract the intestine fragment damaged.
A new non-invasive diagnostic test
GoodGut is developing a new non-invasive diagnostic test to detect Inflammatory Bowel diseases like Crohn that is being tested on patients in a clinical study in the Dr. Josep Trueta University Hospital in Girona. The new method is called RAID-CD and is based in a patented system which identifies bio-markers in the excrements. This will allow an early detection and also the possibility to predict the start of an active phase, with this information it is going to be possible to improve the therapy. The objective is to get a more specific and effective treatment which will avoid the necessity of a surgical procedure in the long-term. “Raid-CD is going to allow a more efficient control of the illness and this will improve the patient quality life” states doctor Xavier Aldeguer, GoodGut co-founder and Director of the Department of Digestive Diseases in Trueta hospital. Among its potential benefits are a reduction of the number colonoscopies needed and an increase in the treatments efficacy.
GoodGut’s therapeutic prebiotic
GoodGut is currently developing Previpect, a therapeutic prebiotic which fosters a selective growth of the beneficial microorganisms we have in our intestinal flora which helps to compensate the dysbiosis that patient usually have. This can reduce the outbreaks and increases the treatments efficacy. This prebiotic can represent a conceptual change in the Inflammatory Bowel Diseases therapy. As it is a prebiotic, its regulation process is faster so it is going to be soon in the market. GoodGut expects it to be available by 2019.
GoodGut will be an active participant in the eleventh edition of BIO-Europe Spring, to be held in Barcelona from 20th to 22nd March. BIO-Europe Spring is the most important European conference for the biotechnology and pharmaceutical industry, this year expecting to welcome over 1,400 companies from the sector, with over 2,400 participants. The 2017 event is organised by EDB Group with the collaboration of Biocat and ACCIÓ.
The Medical Director of GoodGut, Dr Xavier Aldeguer, and the CEO, Dr Mariona Serra, will take part in the panel discussion Key Considerations in Microbiome Partnering, on 20th March at 4 pm, with Michel de Baar from MSD, Eric de La Fortelle from Seventure and Mike Ward from Informa Pharma Insights.
The human microbiome is garnering research interest across the globe and industry is responding to the growing possibilities of therapeutic developments in a variety of ways, a key aspect of which is partnerships. The current state of play means emerging companies are often looking for specific expertise or experience in their partners, often influenced by the variety of approaches under different regulatory jurisdictions or financial structures. Join this panel to hear how emerging microbiome companies identity their preferred partners and what pharma companies and funders are able to bring to the panel discussion.
GoodGut considers intestinal microbiota to be a determining factor in the appearance of digestive diseases and the focus of its research and the new non-invasive tests (in clinical trial phase) which will help to improve early diagnosis.
Over the three days, GoodGut will also take the opportunity to hold private 30-minute meetings with other international executives and business developers. The conference is expected to lead to 12,500 meetings of this type.
Barcelona previously hosted the conference in 2010 and 2013 and the fact that it is doing so again reasserts Catalonia’s strategic position as a pioneering international business centre for the life sciences and healthcare.
Photo: BIO-Europe Spring Barcelona 2013 – Biocat
With the theme Advancing Knowledge, Improving Care, Barcelona played host to the 12th Congress of ECCO (European Crohn’s and Colitis Organisation) on inflammatory bowel disease (IBD). This congress is an unmissable event for scientists and medical specialists from around the world wishing to explore the latest research and clinical care trends in the field.
GoodGut, which began clinical trials of a non-invasive system for detecting IBD (RAID-CD) at Dr. Josep Trueta University Hospital in Girona, with a population of 100 patients, was one of the companies taking part in the congress. IBD includes both Crohn’s disease and ulcerative colitis.
Specifically, two scientific posters were presented by Joan Amoedo, researcher in a team through the Industrial Doctorates Scheme of the Generalitat of Catalonia. The most relevant result on the first poster, which was one of the most consulted, described the excellent capacity of the phylogroups (PHGI and PHGII) to discriminate between ulcerative colitis and Crohn’s disease patients exclusively affecting the colon.
The most significant result on the second poster was that the PHGI and PHGII have proven to be good active phase indicators, providing for the possibility of a different activity marker for each disease. In this case, as Joan Amoedo explains, “it was detected that an increased number of patients was required to validate the markers as a parameter of activity for both diseases”. As a result, the corresponding clinical trials for the differential diagnosis and monitory of inflammatory bowel disease, and the use of these markers to predict the response to anti-TNF treatments such as post-operative recurrence are currently being conducted at Dr. Josep Trueta University Hospital in Girona, Bellvitge University Hospital and Germans Trias i Pujol University Hospital.
Both diseases are chronic and tend to appear in young people (before the age of 30). An estimated 2.5–3 million people in Europe are affected by IBD. In Spain, Crohn’s disease affects around 137.2 people out of every 1000 and, according to ACCU, ulcerative colitis is more common than Crohn’s disease (58% compared to 42%).
Currently IBD is diagnosed with the support of clinical indices and inflammatory parameters such as calprotectin. However these parameters are not sufficiently accurate and generally do not determine when there will be a flare-up of the disease. As a result, a colonoscopy is always necessary, despite being a highly invasive technique with risk of death. In order to diagnose and monitor these chronic diseases the GoodGut system makes it possible to consider one kilogram of bacteria living inside the body which, when unbalanced, are responsible for causing inflammatory response. The RAID-CD can thus be used for non-invasive identification in faeces of the specific microbiological signature for each disease and the degree of dysbioisis can be measured to monitor the disease correctly and provide effective treatment guidelines.
Dr Mariona Serra, co-founder and CEO of GoodGut, is one of the women who inspired the work of Catalunya Emprèn in 2016. Her contribution was mentioned within the scope of FemTalent Fòrum 2017, at a round table held on 20 January in Barcelona and led by Montserrat Sànchez, programme communication manager at Catalunya Emprèn; Almudena Castillo, programme management manager at Catalunya Emprèn and Maria José Blanco, manager of the Barcelona Activa Women Entrepreneurs School. Two of the other guests were from the field of health and life sciences: Dr Teresa Tarragó of Iproteos and Raquel Riera of Biocat.
Female talent is becoming a force to be reckoned with in Catalonia. According to figures from Xarxa Emprèn, a public-private business start-up advice and support network, for 2015, out of all the entrepreneurs advised, 50.21% were women and 49.79% were men. And out of the businesses created, 46.73% were the initiative of women.
Mariona Serra, who has a doctorate in pharmacology, started her entrepreneurial life after a post doctorate degree at Biomedical Research Institute of Girona (IDIBGI), then later an Advanced Management Programme at Iese to complement it. In 2014, Serra founded the biotechnology company GoodGut with Dr Xavier Aldeguer and Dr Jesús García-Gil. She is currently also a member of the Social Council of the Universitat Autonòma de Barcelona, where she chairs the University-Business Committee. Her motto, as she explains in this Biocat interview, is “do business in a team and create your own virtuous circle”.
GoodGut was the only Catalan company selected by the European Commission Executive Agency for SMEs (EASME) to take part in the IPEM 2017 investment forum, from 24 to 26 January in Cannes (France), attended by a total of 120 companies.
It is one of the most important occasions in Europe for private and corporate investors seeking business opportunities to meet innovative companies from a range of economic sectors. The CEO of GoodGut, Dr Mariona Serra, was responsible for presenting the business model to over 150 investors from France, Luxembourg, Germany, Belgium, the United States, Canada and China. “IPEM has given us visibility and access to a network of potential investors in the international arena” she told us.
Serra also commented that GoodGut is a pioneer in designing systems to support diagnosis and treatment for digestive diseases based on intestinal microbiota. Along these lines, investors were interested in the company’s two tests currently in pre-clinical trial phase: RAID-CRC as a new non-invasive system for early detection of colorectal cancer using biomarkers, as it is the second highest cause of death by cancer in the world and the cancer which most affects the Spanish population, and RAID-CD for inflammatory bowel diseases, mainly Crohn’s disease and ulcerative colitis.
Since it was founded in 2014, GoodGut has raised €795,000 from family, friends and fools, angel investors, Caixa Capital Risc and Institut Català de Finances (ICF-IFEM), and one million euros of competitive public financing through the Retos and Neotec programmes.
Forging bonds with future industrial partners for the innovative non-invasive system for early detection of colorectal cancer (RAID-CRC) is the goal GoodGut has set for their time at Biospain 2016, as well as at other events in the sector over the coming months.
Biospain, which will be held from 28 to 30 September in Bilbao by the Spanish Association of Biotech Companies (Asebio), has become the meeting point for biotechnology firms in Spain, attracting more than 850 companies and investors from 37 countries.
Clinical study begins at five hospitals in Catalonia
RAID-CRC has recently received funding through the Ministry of the Economy and Competitiveness 2016 ‘Retos’ programme. It will also begin clinical validation this September with 500 patients at the Dr. Josep Trueta University Hospital, Bellvitge University Hospital, Catalan Institute of Oncology, Vic University Hospital and Santa Caterina Hospital in Girona. “We will analyse different risk groups and that will allow us to better establish who the product targets,” explains Mariona Serra, CEO of GoodGut. The company has also begun the national phase of PCT (Patent Cooperation Treaty).
The current screening method is the faecal occult blood test (FOB), but it isn’t as effective as it is less specific and doesn’t detect pre-symptomatic CRC adenomas. The new system being developed by GoodGut is based on bacterial markers in faeces and will allow doctors to pre-diagnose colon cancer and determine risk levels in the early stages.
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Just days after the good news that the Ministry of the Economy and Competitiveness had granted GoodGut €1.1 million under the 2016 Retos programme, the company found out that it will also receive support from the 2015 CDTI Neotec grants: €175,000.
In this case, the funding will not go to developing a specific project but be used to consolidate the company’s research lines and its laboratory located at the University of Girona Science and Technology Park.
The Neotec grants are among the most competitive in the science/business arena in Spain. More than 500 SMEs participated in this call for proposals. The aspects that the CDTI gives the most weight are that the business strategy be based on technological development, as a competitive factor to set the company apart, and that it has its own lines of R&D.