New Amsterdam Sciences Announces Pre-IND Phase 2 Submission with FDA Coronavirus Treatment Acceleration Program for NAS150 Targeting the Omicron Variant and all variants of SARS-CoV-2

December 03 18:27 2021
NAS Proposes Phase 2 Clinical Stage Agent Can Be an Effective Treatment and Adjuvant Therapeutic for COVID-19. NAS150 Application Could Also Potentially Be Applied for COVID-19 Central Nervous System Conditions specifically those related to “Long Haul” conditions

New Amsterdam Sciences, a privately held bioscience company, announces the filing of the Company’s newly provided materials and data with the FDA’s Coronavirus Treatment Acceleration Program under a pre-Investigation New Drug Phase 2 submission. This submission is a response to a recent response from the FDA with requests relating to a previous submission just weeks prior. The FDA submission is for the advancement of the Company’s therapeutic agent candidate that has antiviral prospect currently being evaluated and confirmed; NAS150 for the treatment of COVID-19 which is caused by the SARS-CoV-2 virus and its variants. The Company is also confident that NAS150 would be therapeutically beneficial for treating other viral-related diseases such as pneumonia, seasonal and pandemic influenza.

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 has cross-referenced collected data from the Phase 1 studies for NAS150 and is preparing Phase 2 protocols to pursue FDA Emergency Use Authorization of NAS150 for treating COVID-19.

“While the search for a vaccine is over and serious progress is being made against the pandemic, it is no secret that there remains an urgent need for therapeutics and therapeutic antivirals like NAS150 to combat the acute symptoms and severe conditions patients are experiencing related to COVID-19 as well as the “Long Haul” conditions continuously being confirmed by physicians. This is on top of new variants that are becoming more prevalent and whose impact we are still learning more about each day,” said New Amsterdam Sciences’ CEO, Michael Wilhelm. “We look forward to our compound NAS150 joining the many other remarkable companies and facilities working tirelessly to develop lifesaving treatments and symptom mitigators for COVID-19 patients across the globe.” The global coronavirus (COVID-19) current therapy market is expected to grow from $14.63 billion in 2020 to $16.8 billion in 2021 at a compound annual growth rate (CAGR) of 14.8%. The market is expected to reach $35.42 billion in 2025 at a CAGR of 20%.

New Amsterdam Sciences proposes that their Phase 2 clinical stage antioxidant, anti-inflammatory agent and potential antiviral, the superoxide dismutase (SOD) mimetic NAS150, can be an effective treatment and adjuvant therapeutic for the Omicron variant of SARS-CoV-2 infection and all other variants. 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 radiation injury and could be a single agent/adjuvant drug of choice for the treatment of patients soon after infection or with severe viral-infection-induced complications. It can directly mitigate cytokine production induced by oxidative stress in both infected airway cells and by infiltrating white blood cells such as activated neutrophils, macrophages and monocytes by a direct SOD mimetic activity. Modulating cellular redox status with NAS150 would alter the energy balance by pushing activated macrophages and neutrophils as well as damaged airway tissue to an overall less inflammatory state while reducing the chances of developing Acute Respiratory Distress Syndrome (ARDS) and cytokine storms which have been observed in patients who progressed to severe COVID-19.

Ongoing efforts for COVID-19 therapeutics are focused on developing compounds that target the SARS-CoV-2 virus either by inhibiting its replication or blocking it from binding entry receptors on host cells. While effective for treating early stage infections, these compounds are not helpful for those patients who progress onwards to severe disease. There is clear evidence that SARS-CoV-2 increases oxidative stress in host cells in early stage infection in order to facilitate its replication. This strongly suggests that using potent antioxidants can be an alternative and/or complementary antiviral strategy. In fact, recent studies have shown that SOD mimetics have antiviral activity towards SARS-CoV-2. “NAS150 is uniquely positioned among COVID-19 therapeutics in that its potential antiviral activity and host-targeted therapeutic capabilities could allow it to be used to treat COVID-19 across all stages of disease states.” Says New Amsterdam Sciences’ Executive Vice President, Dr. Chris van de Wetering.

The combination of antioxidants (especially those displaying direct antiviral activity) with targeted antiviral drugs, as currently being pursued in dozens of clinical studies worldwide, could synergistically reduce the lethal effects of virus infections, by both direct anti-viral actions and by mitigating the complications of viral infection. NAS150’s potential antiviral capability could prove to be a double-edged sword against this virus and all variants thereof. Studies for the confirmation of antiviral activity to compliment the existing therapeutic success are underway for New Amsterdam Sciences.

Thus, one would expect that treatment with this Phase 2 ready, GMP-compliant clinical trial material would both reduce viral load and virus-related inflammation. Such dual actions by this single agent would subsequently lead to a measurable reduction in cytokine production and decrease morbidity and mortality to viral infection.

Michael Wilhelm, CEO for New Amsterdam Sciences added, “Considering the current dearth of effective agents against SARS-CoV-2, our clinic-ready, multi-pronged therapeutic with antiviral prospect continues to get the deserved rigorous evaluation it is positioned for. Inflammation driven by oxidative stress caused by the virus and a person’s exaggerated immune response to the infection are key factors in the severity of COVID-19 patients. We have the opportunity to help save lives, dampen the infection, help reduce acute symptoms and offset the development of some of the symptoms associated with ‘Long Haul’ syndrome.”

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 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. 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. 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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