New Amsterdam Sciences, Inc.

Acute radiation syndrome occurs when a person is exposed to high levels of ionising radiation, usually within a short period. Credit: Crystal Eye Studio via Shutterstock. US-based pharma company ReAlta Life Sciences has teamed up with the US National Institute of Allergy and Infectious Diseases (NIAID) to evaluate its acute radiation syndrome (ARS) drug RLS-0071 (PIC1-01). Scientists at the Armed Forces Radiobiology Research Institute (AFRRI), with support from the Radiation and Nuclear Countermeasures Program (RNCP) at NIAID, will assess RLS-0071’s effectiveness in reducing gastrointestinal damage from ARS using a mouse model in preclinical research collaboration. ARS is a severe condition that occurs when a person is exposed to high levels of ionising radiation, usually within a short period. Symptoms can vary depending on the dose and duration of exposure but typically include nausea, vomiting, diarrhoea, and in severe cases, damage to the gastrointestinal tract. Symptoms worsen as the radiation exposure increases. RLS-0071, ReAlta’s leading candidate, is a 15 amino acid peptide conjugated with polyethylene glycol (PEG) and acts by targeting the complement C1q. The drug has received investigational new drug (IND) clearance by the US Food and Drug Administration (FDA) for treating acute exacerbations of chronic obstructive pulmonary disease and acute graft-versus-host disease, and also holds IND clearance, orphan drug designation, and fast track designation for hypoxic-ischemic encephalopathy (HIE), as well as an orphan drug designation from the European Medicines Agency. In the announcement accompanying the collaboration, ReAlta’s chief scientific officer Neel Krishna said: “The anti-inflammatory, dual mechanism-of-action of RLS-0071 enables the rapid inhibition of both complement activation and neutrophil effectors that are key initiators of deadly inflammation in ARS.” See Also: Sorrento Therapeutics gets grant for transdermal drug delivery device with microneedle assembly and reservoir Eli Lilly and Co gets grant for patent granted for nasal drug delivery device In July 2023, Pluri signed a three-year contract worth $4.2m with the NIAID and the US Department of Defense (DoD) to develop its cell therapy avoplacel (PLX-R18) to treat haematopoietic ARS or radiation poisoning. The same month, RedHill Biopharma received additional funds worth $1.7m from the US Government to advance the development of Yeliva (opaganib) as a medical countermeasure for gastrointestinal ARS. Other drugs currently under development for acute radiation sickness include South Korea-based Enzychem Lifesciences’ Phase II mosedipimod (EC-18), and New Amsterdam Sciences’ Phase I small molecule NAS-150 (AEOL-10150).

Please check out the biopharma industry’s COVID-19 stories that are trending for May 11, 2021. News information is not all-inclusive and updates are published once a week on Tuesdays. Here’s a look at some of the top COVID-19 news over the past week. WHO Declares India’s Dual-Variant The World Health Organization (WHO) reclassified the so-called “double mutant” variant spreading in India as a “variant of concern,” which indicates it has become a global health threat. The variant is known as B.1.617 and appears to spread more easily than the wildtype Wuhan strain. Non-hospitalized COVID-19 Patients Have Low Risk of Serious Long-Term Effects A study published in The Lancet Infectious Diseases found that non-hospitalized COVID-19 patients are at low risk of serious long-term effects. However, the authors noted that “increases in visits to general practitioners and outpatient hospital visits could indicate COVID-19 sequelae.” The study was a population-based cohort investigation using patient and health insurance registries in Denmark. Heart Damage Not Linked to Mild COVID-19 Research out of University College of London that analyzed data from 74 SARS-CoV-2-seropositive and 75 seronegative healthcare workers did not find that mild COVID-19 was associated with heart damage. As a result, they do not recommend screening non-hospitalized, asymptomatic COVID-19 patients for longer-term heart problems. Cerecor wins Fast Track Designation The FDA granted Fast Track Designation to Maryland-based Cerecor Inc .’s CERC-002 for treatment of hospitalized patients with COVID-19. CERC-002 is a first-in-class fully human monoclonal antibody targeting LIGHT (tumor necrosis factor superfamily member 14, TNFSF14). It is the only clinical-stage anti-LIGHT therapy and has the potential to treat a number of LIGHT-associated immune diseases including cytokine storm-induced COVID-19 ARDS. New Amsterdam Sciences Aims for Phase II for COVID Asset Privately-held New Amsterdam Sciences, based in Arizona, is eying a Phase II study for its therapeutic agent candidate NAS150 as a treatment of COVID-19. NAS150 is a small molecule catalytic antioxidant SOD (superoxide dismutase) mimetic designed to reduce reactive oxygen species and their oxidation of cellular proteins and lipids. The company believes that NAS150 would be therapeutically beneficial for treating other viral diseases such as pneumonia, seasonal and pandemic influenza. NSAIDs Not Linked to Worsening of COVID-19 Symptoms A new study confirms that NSAIDS, non-steroidal anti-inflammatory drugs, do not worsen COVID-19 symptoms or cause death in hospitalized COVID-19 patients, the University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP) reported . Pfizer/BioNTech’s expanded EUA for COVID-19 Vaccine The U.S. Food and Drug Administration (FDA) expanded the Emergency Use Authorization for the Pfizer and BioNTech vaccine to include adolescents ages 12 to 15 after recent clinical data showed 100% efficacy and “robust antibody responses.” CDC Updates Guidance on COVID-19 Airborne Transmission Last Friday, the Centers for Disease Control and Prevention (CDC) published updated guidance communicating to the public that the coronavirus disease 2019 (COVID-19) is an airborne threat, explicitly stating that transmission and subsequent infection with the novel coronavirus can occur via inhalation of very fine respiratory droplets as well as aerosolized particles. Potential New COVID-19 Vaccine to Protect Against Variants The Infectious Disease Research Institute (IDRI) , Duke Human Vaccine Institute and 3M are working together on a potential vaccine that might protect individuals against multiple variants of SARS-CoV-2, the virus that causes COVID-19, as well as several other coronaviruses. They published their research in Nature. Researchers Concerned on Long COVID Effects on Communities of Color Covid “long haulers” are being taken more and more seriously in the medical communities today. About 60 clinics have now opened across the U.S. for COVID-19 patients whose symptoms go on for weeks or months past the average recovery period of 2 to 6 weeks. It’s now estimated that about 10% of COVID-19 cases become long-haulers. Compared to white, non-Hispanic persons, the CDC shows that cases of COVID-19 in Black persons are 1.1 times higher for cases with a 2.8 times higher hospitalization rate. Likewise, positive cases are two times higher in the Hispanic population with three times the hospitalization rate when compared to the white population. Pfizer/BioNTech and Moderna Seeking Full FDA Approval for Vaccine Six months after receiving Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) for COVID-19 vaccines, Pfizer / BioNTech and Moderna are planning to seek full approval for the preventative medications. Is the COVID-19 Vaccine IP Waiver Concept Flawed? After the Biden administration signaled support last Wednesday for a proposal that would temporarily waive intellectual property (IP) rights on COVID-19 vaccines to accelerate access for poorer countries, pharmaceutical leaders were quick to point out that, among other problems, such a waiver would likely not work. On Thursday, Pfizer chief executive officer, Albert Bourla, stated that the real challenge is manufacturing capacity. Read more here . Authorized COVID-19 Vaccines Proving Effective Against Variants Newly- published studies suggest currently authorized COVID-19 vaccines may be effective for protecting against new and emerging variants of the novel coronavirus, while booster doses of these vaccines may improve the overall efficiencies of these immunizations at combating these variants. Mix-N-Match Vaccines While mix-and-match sounds more like a meal deal at your local fast-food chain, it’s now the colloquial term being used for the approach currently under study in the U.K. for administering two doses of different types of COVID-19 vaccines. Current emergency use approval for coronavirus vaccines in the U.S. is for two shots from the Pfizer-BioNTech vaccine, two shots from Moderna or one from Johnson and Johnson . Researchers believe that combining a viral vector vaccine with an mRNA vaccine would not only help with vaccine supply issues, but also boost vaccine response. Read more here . Diabetes and COVID-19 Metabolic comorbidities, including obesity and type 2 diabetes increase the risk of morbidity and mortality in patients who contract coronavirus disease 2019 (COVID-19). But recent findings published in the journal Nature show that not only are patients with diabetes more at risk of more severe outcomes, patients without diabetes who develop COVID-19 may also be at a higher risk of actually developing diabetes following recovery. Read more here .

News information is not all-inclusive and updates are published once a week on Tuesdays. Here's a look at some of the top COVID-19 news over the past week. WHO Declares India’s Dual-Variant The World Health Organization (WHO) reclassified the so-called “double mutant” variant spreading in India as a “variant of concern,” which indicates it has become a global health threat. The variant is known as B.1.617 and appears to spread more easily than the wildtype Wuhan strain. Non-hospitalized COVID-19 Patients Have Low Risk of Serious Long-Term Effects A study published in The Lancet Infectious Diseases found that non-hospitalized COVID-19 patients are at low risk of serious long-term effects. However, the authors noted that “increases in visits to general practitioners and outpatient hospital visits could indicate COVID-19 sequelae.” The study was a population-based cohort investigation using patient and health insurance registries in Denmark. Heart Damage Not Linked to Mild COVID-19 Research out of University College of London that analyzed data from 74 SARS-CoV-2-seropositive and 75 seronegative healthcare workers did not find that mild COVID-19 was associated with heart damage. As a result, they do not recommend screening non-hospitalized, asymptomatic COVID-19 patients for longer-term heart problems. Cerecor wins Fast Track Designation The FDA granted Fast Track Designation to Maryland-based Cerecor Inc.’s CERC-002 for treatment of hospitalized patients with COVID-19. CERC-002 is a first-in-class fully human monoclonal antibody targeting LIGHT (tumor necrosis factor superfamily member 14, TNFSF14). It is the only clinical-stage anti-LIGHT therapy and has the potential to treat a number of LIGHT-associated immune diseases including cytokine storm-induced COVID-19 ARDS. New Amsterdam Sciences Aims for Phase II for COVID Asset Privately-held New Amsterdam Sciences, based in Arizona, is eying a Phase II study for its therapeutic agent candidate NAS150 as a treatment of COVID-19. NAS150 is a small molecule catalytic antioxidant SOD (superoxide dismutase) mimetic designed to reduce reactive oxygen species and their oxidation of cellular proteins and lipids. The company believes that NAS150 would be therapeutically beneficial for treating other viral diseases such as pneumonia, seasonal and pandemic influenza. NSAIDs Not Linked to Worsening of COVID-19 Symptoms A new study confirms that NSAIDS, non-steroidal anti-inflammatory drugs, do not worsen COVID-19 symptoms or cause death in hospitalized COVID-19 patients, the University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP) reported. Pfizer/BioNTech's expanded EUA for COVID-19 Vaccine The U.S. Food and Drug Administration (FDA) expanded the Emergency Use Authorization for the Pfizer and BioNTech vaccine to include adolescents ages 12 to 15 after recent clinical data showed 100% efficacy and “robust antibody responses.” CDC Updates Guidance on COVID-19 Airborne Transmission Last Friday, the Centers for Disease Control and Prevention (CDC) published updated guidance communicating to the public that the coronavirus disease 2019 (COVID-19) is an airborne threat, explicitly stating that transmission and subsequent infection with the novel coronavirus can occur via inhalation of very fine respiratory droplets as well as aerosolized particles. Potential New COVID-19 Vaccine to Protect Against Variants The Infectious Disease Research Institute (IDRI), Duke Human Vaccine Institute and 3M are working together on a potential vaccine that might protect individuals against multiple variants of SARS-CoV-2, the virus that causes COVID-19, as well as several other coronaviruses. They published their research in Nature. Researchers Concerned on Long COVID Effects on Communities of Color Covid “long haulers” are being taken more and more seriously in the medical communities today. About 60 clinics have now opened across the U.S. for COVID-19 patients whose symptoms go on for weeks or months past the average recovery period of 2 to 6 weeks. It’s now estimated that about 10% of COVID-19 cases become long-haulers. Compared to white, non-Hispanic persons, the CDC shows that cases of COVID-19 in Black persons are 1.1 times higher for cases with a 2.8 times higher hospitalization rate. Likewise, positive cases are two times higher in the Hispanic population with three times the hospitalization rate when compared to the white population. Pfizer/BioNTech and Moderna Seeking Full FDA Approval for Vaccine Six months after receiving Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) for COVID-19 vaccines, Pfizer/BioNTech and Moderna are planning to seek full approval for the preventative medications. Is the COVID-19 Vaccine IP Waiver Concept Flawed? After the Biden administration signaled support last Wednesday for a proposal that would temporarily waive intellectual property (IP) rights on COVID-19 vaccines to accelerate access for poorer countries, pharmaceutical leaders were quick to point out that, among other problems, such a waiver would likely not work. On Thursday, Pfizer chief executive officer, Albert Bourla, stated that the real challenge is manufacturing capacity. Read more here. Authorized COVID-19 Vaccines Proving Effective Against Variants Newly-published studies suggest currently authorized COVID-19 vaccines may be effective for protecting against new and emerging variants of the novel coronavirus, while booster doses of these vaccines may improve the overall efficiencies of these immunizations at combating these variants. Mix-N-Match Vaccines While mix-and-match sounds more like a meal deal at your local fast-food chain, it’s now the colloquial term being used for the approach currently under study in the U.K. for administering two doses of different types of COVID-19 vaccines. Current emergency use approval for coronavirus vaccines in the U.S. is for two shots from the Pfizer-BioNTech vaccine, two shots from Moderna or one from Johnson and Johnson. Researchers believe that combining a viral vector vaccine with an mRNA vaccine would not only help with vaccine supply issues, but also boost vaccine response. Read more here. Diabetes and COVID-19 Metabolic comorbidities, including obesity and type 2 diabetes increase the risk of morbidity and mortality in patients who contract coronavirus disease 2019 (COVID-19). But recent findings published in the journal Nature show that not only are patients with diabetes more at risk of more severe outcomes, patients without diabetes who develop COVID-19 may also be at a higher risk of actually developing diabetes following recovery. Read more here.