Houston, TX (May 2020) – Pulmotect, Inc., a clinical-stage biotechnology company, has received approval from the U.S. Food & Drug Administration (FDA) to initiate two COVID-19 Phase-2 clinical trials of its innate immune-stimulating drug PUL-042. The Company plans to start accrual within the next week at up to twenty U.S. sites. The trials are for the prevention of infection with SARS-CoV-2 and the prevention of disease progression in patients with early COVID-19 disease. Funding for the trials came from the final closing of the Company’s offering of Series B Preferred stock in March.
Coronaviruses are a large family of viruses that cause disease in animals and humans. They were discovered as a cause of the common cold more than 50 years ago. In some studies, up to 30% of colds in children and adults were caused by these viruses. Coronavirus colds, in temperate climes, have a clear seasonality with a preference for the winter months (Figure below). They occur more sporadically in tropical climates, but there they seem to prefer spring and fall.
CF = complement-fixing antibody
UPDATE April 04. 2020.
The number of confirmed cases of COVID19 approaches 1M globally. Since too many drug repurposing programs and vaccine development projects have been urgently initiated, we decided to summarize them in a separate post:
With this, we stop further updates of this news roll, all new COVID research will be reported the Running List -- stay safe and healthy!
UPDATE March 18, 2020:
BREAKING: China says a flu drug favipiravir approved in Japan was effective in a study of 340 coronavirus patients. According to official sources, the drug is effective in mild or moderate cases. Patients treated with favipiravir turned Covid-19-negative after a median of 4 days since the initial positive test -- which is a substantial improvement compared with a median of 11 days for the untreated patients. X-rays examinations confirmed improvements in lung condition in about 91% of the patients treated with favipiravir vs 62% or those without the treatment.
UPDATE March 17, 2020: The first clinical trial for the Wuhan coronavirus (COVID-19) vaccine has started in the US from today on -- for mRNA based vaccine developed through a partnership between the US National Institute of Allergy and Infectious Diseases (NIAID) and Moderna Therapeutics. Notwithstanding the record-breaking speed for this Phase 1 clinical trial to have begun, the vaccine will be available to the general public not earlier than a year from now, in the best-case scenario.
UPDATE March 14, 2020: FDA Approves Roche’s Coronavirus Test, which will speed up testing by an order of magnitude. This is the first commercially-available test which takes around 3.5 hours.
A detailed live statistics for Wuhan coronavirus shows the current number of 155,209 cases, 5,811 deaths, 74,262 recovered. A full list of biotech companies rallying in this space -- at the end of this post.
UPDATE Feb 5, 2020:
- Utah medtech Co-Diagnostics Inc (NASDAQ: CODX), a developer of a test for the Wuhan virus strain
- Integrated DNA Technologies (IDT) has already shipped synthetic genes for use in the pursuit of coronavirus vaccines, and customized oligonucleotide probes and primers to help accurately detect the Wuhan virus.
- Cerus Corporation (NASDAQ: CERS) uses proprietary technology to treat the SARS strain, currently looking to adapt its approach to the novel virus
- Distributed Bio is developing Centivax, a new kind of universal vaccine, but it is unclear how and when it can be applied to the current strain
- GenScript is freely offering to researchers a qRT-PCR detection assay based test for coronavirus, which might be helpful to detect infection early
- Mammoth Biosciences develops a toolbox for the next generation of CRISPR-based diagnostics, partners with SF based researchers developing a precise diagnostics test against coronavirus.
- Sherlock Biosciences is a biotech startup developing CRISPR-based test for coronaviruses -- it requires a blood, urine, or saliva sample for the analytics.
- AbCellera is trying to identify antibodies that can neutralize the virus and block transmission.
UPDATE Feb 04, 2020: A number of biotech companies also join the race to develop treatments or vaccines against Wuhan coronavirus, including US biotech companies such as Regeneron Pharmaceuticals and Vir Biotechnology. Regeneron studies a combination of neutralizing monoclonal antibodies REGN3048 and REGN3051, while Vir is "working to rapidly determine whether its previously identified anti-coronavirus monoclonal antibodies (mAbs) bind and neutralize 2019-nCoV, also referred to as 'Wuhan coronavirus.'" Shares of Vir Biotechnology surged as much as 38% upon announcement to join the race.
Following the coronavirus outbreak, a total death toll raised up to 427, with more than 20.500 infected people confirmed globally.
UPDATE Jan 31, 2020: WHO declared Wuhan coronavirus a global health emergency, hours after the first registered case of human-to-human transmission in the US. A total death toll raised 213, with almost 10,000 cases confirmed globally.
A Wuhan coronavirus outbreak was first reported in early January 2020 and since that time more than 4,500 people have been confirmed to be infected, and 106 dead (actual as of Jan 28th) -- primarily in an 11 million city of Wuhan, the capital of the Chinese province Hubei. More than 70 cases were reported in 17 other places outside China, including at least 5 cases in the US.
What is Wuhan coronavirus?
Wuhan virus (WHO 2019nCoV) is a positive sense, single stranded RNA beta coronavirus, a member of Beta-CoV lineage B (subgenus Sarbecovirus), supposedly able for human-to-human transmission -- according to Zhong Nanshan, head of the health commission team which investigates the outbreak. The RNA sequence is around 30 kb in length.
New research, published in The Lancet Infectious Diseases, presents the first clinical results with CAL02 in patients suffering from severe pneumonia, the first cause of infectious mortality in the world.
The findings are of significance for pharmaceutical companies and the medical sector. This is in the context of a time of great struggle for antibiotic companies given the increase in instances of antibiotic resistant bacteria. What is of particular global concern is the acceleration of resistance. U.S. Centers for Disease Control and Prevention (CDC) data finds that many high-income countries are entering a “post-antibiotic era.”