PRESS RELEASE 31 DECEMBER 2023
Amplio Pharma celebrates production of investigational medical product (IMP)
intended for the upcoming phase 1 proof-of-principle (PoP) clinical trial.
Amplio Pharma CEO Marguerite Mensonides stated
”we are extremely proud that we managed to get the first GMP-conform IMP batch produced at the GMP facility of the LUMC right before the end
of this calendar year. And we are very greatful that this has been made possible by the financial support and trust put in us by LEH”
PRESS RELEASE 15 DECEMBER 2023
Amplio Pharma celebrates USPO's notice of allowance for Methotrexate Forte's patent.
Amplio Pharma CEO Marguerite Mensonides stated
”we are the first in decades to achieve this milestone for Methotrexate and it clearly shows that the idea to boost the clinical efficacy and safety of this
cornerstone treatment of autoimmune diseases is both new and innovative. We look forward to bringing this improved version of Methotrexate to
the hands of the patients within the next few years”
PRESS RELEASE 28 SEPTEMBER 2023
Amplio Pharma celebrates seed funding to reach clinical readiness.
Leiden-based start-up Amplio Pharma B.V. has successfully closed a seed funding round with Libertatis Ergo Holding.
The funding will be used to support preparation of the first clinical trial application for the patent-protected drug candidate Methotrexate Forte, with the potential to improve the lives of 20 million patients globally. Methotrexate Forte is a novel drug product that enhances retention of methotrexate in cells responsible for immune-mediated inflammatory diseases like rheumatoid arthritis, psoriasis and Crohn’s disease.
Amplio Pharma CEO Marguerite Mensonides stated
”we believe that we can successfully develop Methotrexate Forte and help patients by combining our industry experience with the expertise of Leiden University, LUMC and the CHDR in Leiden.”
LEH managing director Rob Mayfield stated
“there is an important role for academia in bringing new and improved drugs to market, especially in Leiden. We were happy to facilitate the collaboration between Amplio Pharma, Leiden University and LUMC with funding and expertise in order to prepare for the first in-human study of Methotrexate Forte in 2024.”
Further funding in 2024 will be used to finance the execution of a healthy-volunteer Proof-of-Principle trial at the CHDR and preparation of a follow-on trial in patients with rheumatoid arthritis. This latter Proof-of-Concept study will be developed and executed in close cooperation with Prof. Dr. Thomas Huizinga of the LUMC Department of Rheumatology. The production of the investigational medical product is taken on by the LUMC Academic Pharma Group led by Prof. Dr. Teun van Gelder, while the Clinical Trial Application (CTA) will be prepared and submitted by the CHDR.
For more information about the development programme of Methotrexate Forte, reach out to: info@amplio-pharma.com
Amplio Pharma: validated medicine, amplified.
About Amplio Pharma B.V.
Amplio Pharma was started in 2020 in Lund, Sweden, by serial entrepreneurs and industry veterans Marguerite Mensonides, Karin von Wachenfeldt and Charlott Brunmark, each with +20 years' experience in developing and marketing pharmaceuticals. In May 2023, Amplio Pharma B.V. was founded and development activities for Methotrexate Forte transferred to Leiden, the Netherlands. The objective of Amplio Pharma is sustainable drug development, with a clear focus on developing improved versions of already great drugs. (www.amplio-pharma.com)
About Libertatis Ergo Holding (LEH)
Libertatis Ergo Holding (LEH) is an independent subsidiary of Leiden University, which invests in science-based start-up companies. (www.libertatisergo.com)
About the Academic Pharma Group
The Academic Pharma Group focuses on both inhouse discovering and developing medicinal products (or targets), as well as supporting external groups in their efforts to bring innovative drug products to the market that are of less interest to the industry, either because they are for rare diseases or because patents for the active pharmaceutical ingredient (API) have run out. Within the infrastructure of the LUMC pharmacy, the group has the infrastructure to produce investigational medical products (IMP) under GMP which can be used in clinical trials. The aim of the group is to contribute with these innovative products to the advancement of health care.
About Center for Human Drug Research (CHDR)
CHDR is an independent institute located in Leiden, the Netherlands, that specializes in cutting-edge, early-stage clinical drug research. Combining innovative methods and technologies, state-of-the-art facilities and talented, motivated researchers helps CHDR maximise their clients’ success. In addition, CHDR the highest priority on their subjects’ safety and comfort, and they play an active role in helping educate the medical and clinical research communities.
About Immune-Mediated Inflammatory Diseases (IMIDs)
IMIDs are a group of chronic diseases with systemic inflammation and multiorgan involvement, including: rheumatoid arthritis (RA), psoriatic arthritis (PsA), psoriasis (Pso), systemic lupus erythematosus (SLE), ankylosing spondylitis (AS), inflammatory bowel disease (IBD) (including the subtypes Crohn’s and ulcerative colitis), uveitis, sarcoidosis, atopic dermatitis (AD), connective tissue disorders, asthma, and some neurological diseases, such as multiple sclerosis (MS). These diseases affect 5-7% of the general Western society. IMIDs are chronic and progressive diseases and, notwithstanding, different clinical manifestations, cause debilitating pain and fatigue, skin manifestations and multiorgan dysfunction starkly reducing both the patient’s quality of life and lifespan. The chronic disabling conditions that IMIDs impose when left (under)treated, result in job loss or early retirements, adding to socioeconomic impact of these diseases.
About Methotrexate
Low dose methotrexate (MTX) is the cornerstone in the treatment of IMIDs like rheumatoid arthritis (RA) and other forms of inflammatory arthritis. However, a majority of the patients need to take additional drug products on top of their MTX due to inefficacy, resulting in higher disease burden and/or more societal expenses. From recent studies it has become apparent that this is related to the quick elimination of MTX from the pro-inflammatory cells.