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Trump Tests Positive; Gilead Sells Remdesivir Direct; COVID Kills Pain?

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President Trump and First Lady Melania Trump announced they both tested positive for COVID-19 and are currently quarantining together. (MedPage Today)

Trump’s announcement on Twitter came just a few hours after one of his closest aides, Hope Hicks, tested positive as well. (Bloomberg)

However, Vice President Mike Pence and his wife Karen tested negative this morning, the VP’s press secretary tweeted.

This comes after 25 states saw a rise in cases in just the past week. (Axios)

As of 8:00 a.m. ET Friday, the unofficial U.S. COVID-19 toll stood at 7,279,065 cases and 207,816 deaths — up 44,808 and 853, respectively, in the past 24 hours.

Things are heating up over in Europe too, as Italy experienced more than 2,000 cases in 24 hours for the first time since the end of April. (U.S. News & World Report)

Gilead Sciences said its now meeting real-time demand for remdesivir (Veklury) in the U.S., and hospitals can now buy the drug directly from the company in whatever quantities they need.

A new study looking at contract tracing data confirmed children can indeed spread the virus, but not quite as much as young adults. (CNN)

Pfizer CEO Albert Bourla was “disappointed” that Trump politicized the vaccine review timeline during the debate with Joe Biden. (Politico)

A mental health czar should be appointed to the White House’s coronavirus task force, says Monica Lewinsky. (Vanity Fair)

European mink farmers are now battling SARS-CoV-2 outbreaks in their herds. (Reuters)

But University of Arizona researchers find that coronavirus infection relieves neuropathic pain in an animal model, and speculate that an effect like that in humans could facilitate disease spread. (Pain)

In other news:

  • The latest vectors for Salmonella outbreaks: pet hedgehogs and bearded dragons. (CDC)
  • Chrissy Teigen and John Legend lost what would have been their third child after she suffered complications and severe bleeding halfway through the pregnancy. (CNN)
  • Universal Health Services said it’s working to restore its network after a ransomware attack knocked it out for five days. (Reuters)
  • How ironic — U.S. coal baron Robert Murray is seeking federal benefits to treat what he now says is black lung disease after years of stonewalling coal dust regulation. (Ohio Valley Resource)
  • author['full_name']

    Kristen Monaco is a staff writer, focusing on endocrinology, psychiatry, and dermatology news. Based out of the New York City office, she’s worked at the company for nearly five years.

Source Article

Poxel Announces Positive Results From Phase 2a NASH Trial With PXL770, an Oral First-in-Class Direct AMPK Activator

  • The Phase 2a trial for the treatment of NASH met its primary efficacy endpoint; PXL770-treated patients achieved statistically significant improvement in the relative decrease in liver fat mass measured by magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF) at 12-weeks with a greater response in patients with type 2 diabetes1

  • Key secondary measures in PXL770-treated patients included statistically significant observed improvements in liver enzymes – alanine transaminase (ALT) and hemoglobin A1c (HbA1c)

  • PXL770 was observed to be safe and well tolerated; profile supports further evaluation for combination use

  • First human clinical assessment of a direct AMPK activator; results support potential for development in NASH including key high-risk subgroups (patients with type 2 diabetes) and utility of AMPK activation in other chronic and rare metabolic diseases

  • Conference call in English scheduled today for 12:00 pm EDT (New York time) / 6 pm CEST (Paris time)

POXEL SA (Euronext: POXEL – FR0012432516), a biopharmaceutical company focused on the development of innovative treatments for metabolic disorders, including type 2 diabetes and non-alcoholic steatohepatitis (NASH), today announced positive top-line results for STAMP-NAFLD, the PXL770 Phase 2a trial. The Phase 2a trial was a 12-week, randomized, parallel group study, in 120 presumed NASH patients with or without diabetes. PXL770 is a first-in-class, oral direct adenosine monophosphate-activated protein kinase (AMPK) activator. AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and a range of other chronic and rare metabolic diseases.

“The underlying pathophysiological drivers of nonalcoholic fatty liver disease (NAFLD) and NASH are highly complex and support the need for development of novel therapies acting on different targets that can address a variety of key disease drivers,” said Vlad Ratziu, MD, PhD, Professor of Hepatology, Sorbonne University and Pitié-Salpêtrière Hospital. “AMPK activation is a differentiated approach for NASH and these results demonstrate that it could have a beneficial role in controlling key pathways that lead to liver injury. By also directly targeting inflammation and fibrogenesis, as demonstrated in preclinical models including human cells, PXL770 has the potential to independently impact multiple disease components. As an oral agent, PXL770 also has the potential to be used in combination with other agents, which could provide for broad treatment of this disease.”

Summary of STAMP-NAFLD PXL770 Phase 2a Study Results

STAMP-NAFLD was a 12-week randomized, placebo-controlled, parallel group trial in 120 presumed NASH patients, with or without diabetes, which evaluated three dosing regimens of PXL770 versus placebo. Primary enrollment criteria were evidence of hepatic steatosis (NAFLD) based on a controlled attenuation parameter (CAP) score of >300 db/m measured by MRI-PDFF. Patients were randomized into four groups: PXL770 at 250 mg once-daily (QD); 250 mg twice-daily (BID); 500 mg once-daily (QD) versus patients who received placebo.

The Phase 2a trial met its primary efficacy endpoint; PXL770 was observed to produce a statistically significant mean relative decrease of 18% in liver fat mass from baseline at 12-weeks in the 500 mg QD dose