How we got here?
Successful initiation for FiH Study with VS-01
VERSANTIS initiated its first clinical study site which will trial VS-01 in patients: Goethe University Hospital Frankfurt. This site was trained on the protocol and is now actively screening to enroll patients!
Following recent approvals by both the German regulatory authorities (BfArM) and by the hospital's independent Ethics Committee, VERSANTIS has now initiated a Phase 1b study with VS-01, a lifesaving multi-organ support therapy able to enhance the clearance of ammonia and other toxins from the body. This open-label phase 1b, multi-cohort, single ascending dose and multiple dose study is being conducted at Goethe University Hospital in Frankfurt am Main, Germany, with the primary objective to characterize the safety, tolerability, and pharmacokinetics of VS-01 in patients with decompensated liver cirrhosis and covert hepatic encephalopathy.
Only 4 years after incorporation, this clinical initiation marks a new era for VERSANTIS. The Company expects to complete this Phase 1b study and advance VS-01 to the subsequent Phase 2 trials by spring 2020.
Main patent for VS-01 granted in two additional countries.
Versantis is proud to announce that its main patent was accepted for grant in Mexico and South Korea! These are now the 5th and 6th granted patent for the Company! Securing the science & technology behind our lead candidate VS-01.
Versantis is celebrating its 4th birthday!
We embark on a momentous year with a first-in-human clinical trial and a financing round. We give thanks to our team, to our investors and to our founders!
Versantis Strengthens Leadership Team with Appointment of Dr. Med.Sophie Biguenet as Chief Medical Officer
Zurich, Switzerland, December 18st, 2018 – Versantis, a pharmaceutical company developing lifesaving orphan and emergency care therapies for adult and congenital pediatric liver diseases announces the appointment of Sophie Biguenet, M.D., as Chief Medical Officer. Dr. Biguenet, a trained pediatric hepato-surgeon, brings over 15 years of experience in leadership and global drug development to Versantis. In her role, she will oversee Versantis’ global clinical programs and registration strategies, starting with VS-01, an emergency care therapy for hepatic encephalopathy (HE) and Acute-on-Chronic Liver Failure (ACLF). These two indications are serious and potentially life-threatening complications of cirrhosis, which has doubled in the last decade. Innovative initiatives addressing the unmet medical need of this patient community are ever more needed.
“We are delighted to welcome Dr. Biguenet to Versantis,” said Dr. Vincent Forster (CEO). “Sophie is a key addition to our executive team as our lead candidate VS-01 enters first-in-human studies in early 2019. Her strong expertise across multiple therapeutic areas, including hepatology, transplantation, and pediatrics, will be a source of great strength in structuring and realising Versantis’ clinical development programs.” Commenting on the announcement, Dr. Meriam Kabbaj, Versantis co-founder and COO added: “Sophie’s unique combination as a pediatric liver transplant surgeon and as a drug developer is a tremendous asset to help us succeed in the clinical development of our truly innovative drug portfolio. We are proud to add Sophie to our executive team, not only for her strong track record but also as a person. Her career-long focus on creative study designs, rigorous and ethical patient care will be an excellent fit with our mission to make a fundamental difference in the lives of liver impaired patients”.
“This is an exciting moment for Versantis with an imminent first-in-human and multiple other trials planned in various indications. I am thrilled to join this dynamic management team and utilize my experience to bring forward the company’s strong pipeline that addresses some of the most pressing medical needs of underserved patients,” said Dr. Biguenet. “Versantis’ innovative technology has the potential to be a game-changer for patients and their caregivers in the liver and pediatric spaces. A well targeted clinical positioning of each product has raised significant interest within the medical community and will markedly reduce the current burden on the hospital and healthcare cost systems.”
Dr. Biguenet has profound experience in the clinic as a pediatric surgeon as well as in drug development. She has held global leadership positions across medical affairs, drug safety, and clinical development. She led the global (US, EU, AF) development of small molecules and biologics from pre-IND to filing and has an extensive track record in pediatric and neglected diseases. Dr. Biguenet is a board-certified General and Pediatric surgeon who completed her residency at Bicêtre University hospital (Paris, FR). Prior to joining Versantis, she held several leadership positions as Medical Director at Medicines for Malaria Venture (MMV, Geneva), AbbVie (USA), and Bristol-Myers-Squibb (USA and France). She played a leading role in developing the pediatric portfolios in infectious diseases at both Bristol-Myers Squibb and Abbvie and helped introduce calcineurin inhibitors sparing regimens in liver transplantation.
Versantis Establishes Medical Advisory Board comprising five notorious international authorities in hepatology, intensive care, and nephrology. They joined versantis to transform the care of acute liver diseases.
Zurich, Switzerland, March 19th, 2018 – Versantis, a pharmaceutical company on a mission to revolutionize the diagnosis, prevention, and treatment of patients with liver diseases, today announces the formation of a Medical Advisory Board (MAB). The MAB will provide independent advice, overview, and scrutiny to successfully support the clinical development activities. Versantis’ MAB will be multi‐disciplinary including experts in the areas of hepatic encephalopathy, acute-on-chronic liver failure, intensive care, and nephrology; each of them will be a critical asset for carving out the company’s clinical strategy.
The appointees to the MAB will be:
- Prof. William Bernal, MB BS, BSc, MD, FRCP, FFICM
- Sara Montagnese, MD, PhD
- Prof. Stephan Segerer, MD, EMBA UZH
- Prof. Faouzi Saliba, MD, PhD
- Prof. Jonel Trebicka, MD, PhD
Commenting the announcement, Dr. Meriam Kabbaj, Versantis co-founder and COO says: “I am honored to be working with such eminent doctors who will play an important role in guiding Versantis’ clinical development programs and help us fulfill our mission of bringing the first stand-alone therapy to acute-on-chronic liver disease patients with hepatic encephalopathy”.
“Acute-on-chronic liver failure is a complex disease which lacks effective therapeutic options. We are thrilled to have attracted some of the world’s leading experts to tackle this unacceptable status quo” adds Dr. Vincent Forster, co-founder and CEO of Versantis. “Appointing the members of our Medical Advisory Board is a key milestone towards clinical validation of our lead product – VS-01 – and endorses its scientific and medical potential”.
“ACLF has so far very few treatment options, and new advances in the management of ACLF are urgently needed. This is especially important, since this syndrome has a dramatic morbidity and mortality.” explains Prof. Trebicka, chair of the MAB. “ACLF is still poorly understood. Hepatic encephalopathy seems to play an important role in the natural history of ACLF and most of these patients present with ascites requiring paracentesis. Therefore, combining paracentesis with removal of ammonia and other toxic substances, without the need of extracorporeal circulation is a great possibility. This strategy has the potential to change the course of ACLF and even of decompensated liver cirrhosis.”
Versantis welcomes Dr. Rekha Johnson on board as Senior Clinical Manager
With over 15 years-experience in the pharmaceutical industry in clinical trial and data management, she takes a key role of Senior Clinical Manager to organize and supervise the first-in-human clinical trial of VS-01.
Versantis welcomes Prof. Jonel Trebicka as Medical Lead
Prof. Trebicka is Head of the University of Bonn’s Laboratory for Liver Fibrosis and Portal Hypertension since 2012 in the Department of Internal Medicine. He is a recognized authority in the translational and clinical research on liver fibrogenesis, vascular liver disorders, and end-stage liver diseases. Prof. Trebicka will support Versantis' clinical activities and design VS-01 clinical program and strategy.
Versantis secured an additional research funding to advance the R&D for its ammonia diagnostic test TS-01
Financing for a research collaboration with ETH Zurich has been secured from the Swiss Innovation Promotion Agency KTI/CTI for the development of TS-01 - an robust, precise, and flexible ammonia quantification test. These funds will be spent to optimize the technology and bring the current prototype to a validated device for hospital and point-of-care uses.
Versantis main patent granted in Canada
After Australia, Japan, and Russia, the Canadian patent office accepted Versantis' main patent protecting the technology behind VS-01. This is an additional validation of the robustness of Versantis' IP portfolio.
Versantis Announces FDA Grants Orphan Drug Designation to VS-01 for the Treatment of Acute-on-Chronic Liver Failure
July 17, 2017: Versantis, a pharmaceutical company reinventing the diagnosis, prevention, and treatment of patients with liver diseases, today announces that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to VS-01 for the treatment of patients with acute-on-chronic liver failure (ACLF). VS-01 is a proprietary liposomal fluid infused in the abdominal cavity where it enhances the elimination of ammonia and other toxic metabolites responsible of the poor prognosis in ACLF patients.
“ACLF is a recently recognized condition affecting patients with cirrhosis and rapidly progressing to encephalopathy, multi-organ failures, and fatalities. VS-01 is the first drug therapy to simultaneously support both liver and kidneys and promises to transform the lives of affected individuals and their families.” said Dr. Vincent Forster, CEO and co-founder of Versantis. “The granting of orphan drug designation in the U.S. is an important step forward in the development of VS-01 and highlights the high unmet medical need for new therapies in this indication. We are on track to file a clinical trial application in late 2018 and committed to bringing VS-01 to patients in a timely manner.” added Meriam Kabbaj, COO and co-founder of Versantis.
Versantis Raises CHF 4.4 Million in Series A Financing to Advance New Generation of Liver Disease Medicines
Funding brings resources to advance lead candidate VS-01 to first-in-human study and transform the care of patients with rare and life-threatening liver diseases.
Versantis' main patent granted in Japan
After Australia, we are very pleased to report that the Japanese Examiner has also issued the Decision to Grant our patent. This achievement demonstrates the robustness of the intellectual property surrounding our products. We look forward to adding other countries to this list.
The EMA issued a positive opinion on the orphan drug designation for VS-01 for the treatment of acute liver failure.
17 May 2016: the Committee for Orphan Medicinal Products (COMP), in light of the overall data submitted and the discussion within the Committee, issued a positive opinion on orphan medicinal product designation for VS-01 for the treatment of acute liver failure.
Versantis selected for MassChallenge 2016 Accelerator
This year’s MassChallenge Switzerland class was selected from more than 450 applicants across a diverse range of industries and geographies, including 55 countries. The accelerator program will culminate at the MassChallenge Switzerland Awards Ceremony, where entrepreneurs will pitch their start-ups with the chance to win a share of 1 million CHF in zero-equity cash awards.
Versantis awarded with CTI Start-up Label, a seal of quality and maturity.
12 Apr 2016: Versantis received the CTI Label from the Swiss Committee for Technology Innovation. This recognition places Versantis into the selective group of CTI certified Swiss start-ups.
CTI Start-up, an initiative from the Swiss Confederation’s innovation promotion agency is supporting new and innovative enterprises in the high-tech sector with a tailored, hands-on coaching process that culminates with the CTI label, “a seal of quality, a certificate of achievement, and a sign of credibility and readiness for sustainable growth”.
The first and main patent of Versantis granted
We are pleased to report that Versantis' patent application protecting its innovative drug capture platform has now been granted in Australia. This is an important step forward that strengths the intellectual property around VS-01 and the next VS products in the portfolio.
Versantis celebrated its first year!
Congratulations to all the team for their hard and diligent work which kept us up and running. We are proud of all the important milestones achieved this last year and are looking forward to the ones coming up! Big thanks to all our coaches, advisers, and organizations for their continuous support!
Versantis to have its first scientific advice meeting with the EMA in Apr 2016
Versantis submits its briefing document to the EMA summarizing key elements of its preclinical and clinical development and requests a Scientific Advice Meeting with the EMA that has been validated. The procedure will start as planned during the SAWP (Scientific Advice Working Party) meeting on 8–11 February 2016. The scientific advice meeting is to happen in Apr 2016 and will be instrumental to firm up the development plan of VS-01.
Versantis initiates the manufacturing scale up of VS-01
VS-01 is a liposomal peritoneal dialysis fluid that enhances the clearance of toxic metabolites accumulated during acute liver disease. Versantis collaborates with a well-established contract manufacturing organization specialized in the liposomes technology to initiate the industrial production of VS-01. First results of the feasibility study to be available in March 2016.
Congratulations to V. Forster, Winner of the Pfizer Research Award
Versantis congratulates its CEO, V Forster on winning the Pfizer Research Award for its work on liposomes-supported peritoneal dialysis. Thanks to all co-authors and collaborators!
The Pfizer Research Prize, one of the most prestigious for medical research in Switzerland, is awarded by the Foundation to young scientists who have made outstanding and pioneering contributions in basic or clinical research at Swiss research institutes or hospitals.
Versantis receives the SME status and is now eligible for all associated incentives
Versantis is now in the listing of SME companies and on the EMA’s website (reference number C/498/15/01). This is the first regulatory achievement of Versantis that comes with significant incentives namely administrative and procedural assistance from the SME office, fee reductions for procedures including scientific advice, fee exemptions for certain administrative services, assistance with translations of the product information documents, and waiver of the MedDra licensing fee.
Positive in vivo efficacy and safety results pave the way for the regulatory preclinical studies.
Versantis successfully reaches its R&D targets set for 2015. Versantis freezes the formulation of its first product, VS-01, a life-saving solution for patients with acute liver disease. The team manages to set-up a scalable manufacturing process, complete the in vivo proof of efficacy in a rat model of acute liver failure, and assess the in vivo proof of safety in a larger animal model (pigs).
Versantis congratulates to all team members for these achievements and acknowledge them for their hard work and invaluable commitment!
Versantis attends an Innovation Task Force meeting at the EMA and consolidated its preclinical, clinical, and regulatory plan.
The Innovation Task Force (ITF) is a multidisciplinary group at the EMA that includes scientific, regulatory, and legal competences. It was set up to ensure coordination across the European Medicines Agency and to provide a forum for early dialogue with applicants.
The robust science behind Versantis’ technology is rewarded by The Phoenix Group
Versantis congratulates V Forster, Versantis CEO, JC Leroux, Professor at the Institute of Pharmaceutical Sciences ETH Zürich and Versantis co-founder, as well as all the co-authors of the following manuscript awarded by The Phoenix Group Award in the category Pharmaceutical Technology: “Liposome-supported peritoneal dialysis for detoxification of drugs and endogenous metabolites. Science Translational Medicine 6, 258ra141 (2014)”. This is a great recognition of the robust science behind Versantis’ technology.
With its annual prize the PHOENIX Group awards the best scientific work in pharmaceutical research in German-speaking countries. This award is one of the most prestigious science prizes in this region and constitutes a focal point for the company's R&D activities.
Versantis is a finalist of the Wellcome Translation Award
The Wellcome Trust is an independent global charitable foundation dedicated to improving health. The aim of the Wellcome Trust Translation Awards is to develop innovative and ground breaking new technologies in the biomedical area. Versantis submits a project and is shortlisted among hundreds of projects to make it to the final presentation. Versantis receives funding to cover its consultancy activities in regulatory and clinical development as well as constructive feedback from the Wellcome Trust experts and committee members who “were excited about the simplicity of the technology”.
Versantis secured enough funding to complete the R&D for its first product VS-01
Financing for the R&D has been secured in seed funding in March 2015 from the ZKB, the Swiss Innovation Promotion Agency KTI/CTI, and other valuable grants. These funds will be spent to optimize the manufacturing, complete the proof of efficacy and safety of VS-01 and set-up the operational activities.
Versantis receives the support of CHF 320'000.- from The Gebert Ruef Stiftung.
Versantis sincerely acknowledges the Gebert Ruef Stiftung for its significant financial support that will be instrumental for the translation of VS-01 from an academic prototype to a product ready to undergo preclinical regulatory studies and potentially attract investors.
The charter of Gebert Rüf Stiftung founded in 1997 states the purpose article as «promoting Switzerland as a place to live and do business». The mission statement of the foundation provides support for new approaches and selected junior scientists in the so-called valley of death. In line with the support criteria, a project must be impact-oriented and of a high caliber if it is to be eligible. Gebert Rüf Stiftung is not an operating foundation that exclusively maintains its own projects, but is above all a grant-making foundation which actively shapes and enables.
15 March 2015
Versantis was incorporated
Versantis was incorporated in March 2015 as a spin-off of ETH Zürich. Versantis is a start-up company focused on the discovery and the development of innovative solutions in the high unmet medical field of acute liver disease. Versantis counts on a team of three committed founders and dedicated scientists who are experts within their specific area. The team collectively has pharmaceutical, manufacturing, preclinical / clinical expertise, and management skills. Versantis enjoys its unique location in the ie Lab at ETH Honggerberg and the incredible support both in terms of IP funding and the use of laboratories and equipment.
Versantis wins the CHF 100'000.- prize of Venture Kick Stage 3
Versantis sincerely acknowledges The Venture Kick for its financial support, its coaching, and valuable advices throughout the process which considerably fostered Versantis’ maturity in various aspects of its development.
Venture Kick provides spin-off projects at Swiss universities with pre-seed capital, coaching and access to professional investors. Members from a jury pool (100+ leading startup experts across Switzerland) evaluate and support 16 spin-off projects in three sessions every month. Since the inception of the program, 403 startup projects were supported with CHF 16.01 million in pre-seed capital (up to CHF 130.000 per Venture Kick winner). Additionally, the supported startups received hands-on coaching during 234 kickers camps.
Prof JC Leroux receives the support of CHF 50'000.- from the OPO-Stiftung
Prof JC Leroux at the Institute of Pharmaceutical Sciences ETH Zürich and Versantis co-founder receives a financial support of CHF 50'000.- from the OPO-Stiftung for further developing of the academic prototype of Versantis’ product, VS-01
The OPO Foundation is the legacy of the Zurich entrepreneurs Hermine Raths and Marguerite Steiger to posterity. It was established in 1985 in Zurich as a nonprofit operating Foundation committed first and foremost for the promotion of science and research.
Versantis receives the support of CHF 100'000.- from the Volkswirtschaft-Stiftung
Versantis sincerely acknowledges the Volkswirtschaft-Stiftung for its financial support which will help setting up operational and legal activities.
The Swiss Federal Foundation for Promotion of the National Economy through Scientific Research financially supports and furthers the founding of Swiss technology start-ups. The foundation’s purpose is to promote the Swiss economy through innovation. Generally speaking, the foundation promotes applied research that is subsequently exploited in promising commercial applications.