Published by @prwirepro on January 5, 2022January 5, 2022
NAS will utilize the collected data to support Phase 2 initiatives advancing NAS150 as an RA treatment alternative. The Company’s Platform of Inflammatory Reducing Therapeutics is also intended to be leveraged for the treatment of other autoimmune conditions including Multiple Sclerosis
Binghamton, NY – January 5th 2022 — New Amsterdam Sciences, a privately held bioscience company, announces the delivery of the Company’s compound/drug materials NAS150 and data to The University of Liverpool in the UK. The collaboration between NAS and the University of Liverpool has been established to explore NAS150’s candidacy as a rheumatoid arthritis (RA) drug by performing studies designed to elicit additional data demonstrating therapeutic benefit of targeting inflammation caused by uncontrolled neutrophil-derived reactive oxygen species (ROS) production in joints. The data collected will support the Company’s forthcoming Phase 2 pre-IND submission to the FDA for NAS150 to treat RA. RA is a chronic autoimmune inflammatory disorder that leads to a progressive loss of joint tissue and function that can rapidly diminish mobility and quality of life in patients. The studies are being led by immunologist Dr. Helen Wright, Ph.D., from the University of Liverpool. Dr. Wright’s research is focused on understanding how neutrophils, a type of white blood cell that normally defends against foreign invaders, is involved in attacking the body’s own joint tissue in rheumatoid arthritis. Targeting ROS with NAS150 can slow the progression of disease by reducing joint inflammation and tissue destruction thereby allowing RA patients to have increased mobility and a greater quality of life. “We are absolutely thrilled to be collaborating with Dr. Wright and have her lead these pivotal studies. Her expertise in neutrophil biology and rheumatoid arthritis will be key in demonstrating how NAS150 can treat this disease.” says New Amsterdam Sciences Dr. Chris van de Wetering.
Dr. Helen Wright, Immunologist, Ph.D, University Of Liverpool, UK.
In addition to RA, the Company is confident that NAS150 and its other analog NAS114 are therapeutically beneficial for treating ROS-mediated inflammation that drives several other disease indications including multiple sclerosis (MS), pandemic-related coronavirus infections (SARS-CoV-2 and its variants), seasonal and pandemic influenza, and pneumonia.
Additionally, New Amsterdam Sciences Phase 2 Pre-IND is presently approved for exploration as a therapeutic for central nervous system conditions, specifically ALS (amyotrophic lateral sclerosis). The Company will cross-reference collected data from the Phase 1 studies for NAS150 along with the forthcoming data and final reports for RA and is preparing Phase 2 protocol drafts to pursue FDA clinical approval for commercial use.
NAS150 is a Mn-metalloporphyrin SOD mimetic with demonstrated antioxidant and anti-inflammatory activity. It has been backed by sustained Federal R&D support and as a subcutaneous agent, it is being positioned for administration via transdermal/microneedle patch as well as alternative routes. This clinical stage agent was shown to be effective in reducing oxidative stress, inflammation, and tissue damage following neutrophil infiltration in models of radiation and chemical injury to lungs. Neutrophils have been implicated in worsening the injury response by perpetuating tissue damage through uncontrolled release of ROS, hypochlorous acid production, and enhancing pro-inflammatory cytokine production creating a feedback loop of continuous damage and inflammation. In patients with RA, neutrophils have been implicated in perpetuating joint inflammation and tissue damage using this same feedback loop. By targeting neutrophil-derived ROS and breaking the tissue damage – inflammation feedback loop with NAS150, RA patients would suffer less as joint damage and inflammation would be markedly reduced. Studies are underway to confirm NAS150’s applicability to targeting neutrophil-mediated ROS in RA.
New Amsterdam Sciences proposes that their clinical stage Phase 2 ready candidate NAS150 is a viable RA therapeutic that can work as a standalone treatment or in conjunction with currently used RA therapeutics. The global RA therapeutics market size was valued at $22.14 billion in 2018, and is projected to reach $38.3 billion by 2027, registering a CAGR of 5.4% over the forecast period.
Michael Wilhelm, CEO for New Amsterdam Sciences added, “There are many treatments for RA and while they are effective in certain patients, they are also extremely harmful with side-effects that are often difficult to manage. We are confident the side effect profile for NAS150 is far milder than those of its peers. While these other drugs can slow the progression of rheumatoid arthritis and save the joints and other tissues from permanent damage, they are also harmful in other ways. NAS150 is an anticipated candidate that can help break that cycle and offer efficacy, relieve pain and inflammation as well as save the joints from further damage while also mitigating harmful side effects. NAS150 is classified as a DMARD (disease-modifying antirheumatic drug). Common DMARDs include methotrexate (Trexall, Otrexup, others), leflunomide (Arava), hydroxychloroquine (Plaquenil) and sulfasalazine (Azulfidine) and New Amsterdam Sciences is proud to be working alongside these drugs and the companies that make them to help fight against this debilitating illness.” He also says, “Dr. Wright is keenly interested in diseases like rheumatoid arthritis, where our immune cells start attacking the joints and tissues in the body. Helen’s research seeks to understand how we can learn to switch off unwanted inflammation in rheumatoid arthritis which is precisely where our candidate NAS150 is expected to play a significant role in reducing and keeping the pain and debilitating discomfort mitigated for patients that are suffering.”
Dr Wright added “I am delighted to be working with New Amsterdam Sciences on this exciting new project. NAS150 has real potential as a novel treatment for neutrophil-driven diseases like rheumatoid arthritis. There is a real need for more targeted approaches to treating immune-mediated diseases and targeting ROS may be the key to switching off the cycle of unwanted neutrophil activation that is associated with damage to joints and tissues. This new collaboration will determine the effect of NAS150 on several aspects of neutrophil ROS production and activation, and provide important new information on how NAS150 can modulate the immune response in neutrophil-driven diseases like RA.”
Founded in 1881 as the original ‘red brick’, the University of Liverpool is one of the UK’s leading research-intensive higher education institutions with an annual income of £583.5 million, including £95.1 million for research. Consistently ranked in the top 200 universities worldwide, the University is a member of the prestigious Russell Group of the UK’s leading research universities and has a global reach and influence that reflects its academic heritage as one of the country’s largest civic institutions.
ABOUT NEW AMSTERDAM SCIENCES, INC. www.newamsterdamsciences.com.
New Amsterdam Sciences, a wholly-owned subsidiary of NAS Bioholdings, is a clinical-stage biotechnology company developing novel drug candidates for underserved respiratory conditions, oxidative stress driven inflammation related diseases such as rheumatological related conditions and CNS diseases. The Company’s lead compound, NAS150, is a small molecule catalytic antioxidant SOD (superoxide dismutase) mimetic, as are its analogs such as NAS114. These molecules reduce reactive oxygen species (ROS) and subsequently their oxidation of cellular proteins and lipids. They both serve as the company’s lead compounds in NAS’s Platform of Inflammatory Reducing Therapeutics. Also, being researched and is a preclinical candidate is NAS911 which is a neuro/immunomodulator, based on Substance P. NAS911 is a stem cell proliferator that reduces inflammation and leverages the body’s intrinsic homeostatic mechanisms to respond to injury.
FOCUS ON COVID-19
New Amsterdam Sciences, Inc. maintains a strong pipeline for indications that will leverage the NAS150/114 clinical platform however, the company is focused on the development and advancement of the Company’s clinical-stage candidate therapeutic and potential antiviral to treat COVID-19 caused by infection with SARS-CoV-2 and its variants. The lead program leverages prior human studies on the compound under an existing Investigational New Drug Application with the US FDA. The company’s NAS150 COVID-19 Phase I and Phase 2 studies as a therapeutic agent are paramount to the company’s planning and growth even as they relate to other development programs that are established. Additionally, NAS150 is also being developed as a prophylactic candidate (potentially delivered via microneedle patch) to protect “frontline” workers against COVID-19 and as a therapeutic against many of the manifestations of ‘Long Haul COVID syndrome’ and other major indications of unmet medical need.
Findings to date suggest additional opportunities for our focused compound NAS150 along with other interests in the Company’s pipeline contains as a co-therapeutic to a vaccine and antiviral treatments, potential treatment for influenza or other microbial ailments, rheumatoid arthritis, other autoimmune diseases as well as for use as a possible countermeasure for homeland security threats including radiological, chemical and biological agents.
Statements about New Amsterdam Sciences’ future expectations, including statements about the potential use and scientific results for New Amsterdam’s preclinical and clinical drug candidates, science and technology, and all other statements in this press release other than historical facts, are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Securities Litigation Reform Act of 1995. New Amsterdam Sciences intends that such forward-looking statements be subject to the safe harbors created thereby. These future events may not occur as and when expected, if at all, and, together with New Amsterdam’s business, are subject to various risks and uncertainties. New Amsterdam’s actual results could differ materially from expected results as a result of a number of factors, including the uncertainties inherent in research and development collaborations, pre-clinical and clinical trials and product development programs (including, but not limited to the fact that future results or research and development efforts may prove less encouraging than current results or cause side effects not observed in current pre-clinical and clinical trials), the evaluation of potential opportunities, the level of corporate expenditures and monies available for further studies, capital market conditions, and others set forth in.
There are no guarantees that any of New Amsterdam’s proposed products will prove to be commercially successful. New Amsterdam Sciences undertakes no duty to update forward-looking statements.
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