COVID-19 Drug Pipeline:
Is the wait for the drug over?

How long do we have to wait?

Updated: Wednesday, May 20, 2020

Dashboard search results for vaccines and mRNA-1273.

A few weeks ago, we introduced an interactive dashboard that allows users to easily track COVID-19 drugs and vaccines through clinical trials. Data visualizations, sourced from ClinicalTrials.gov data, will provide users with updates on the number of drugs and vaccines in each phase of clinical trials, trials by country, and more.

The dashboard will enable the retrieval of information surrounding recent advancements, such as vaccine candidates, mRNA-1273 by Moderna, which was awarded fast-track designation by the US Food and Drug Administration (FDA) and ChAdOx1 nCoV-19 currently under development at University of Oxford.

Visit and interact with the COVID-19 Drugs and Vaccines Dashboard.

A brief explanation of clinical trial phases and fast tracking

As more drugs advance through clinical trials, we become increasingly curious about the answer to, “How long do we have to wait?” Let’s quickly review the journey of a drug through clinical trials according to the U.S. Food and Drug Administration.

Phase 1

  • Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.
  • Length of Study: Several months
  • Purpose: Safety and dosage
  • Approximately 70% of drugs move to the next phase

Phase 2

  • Study Participants: Up to several hundred people with the disease/condition.
  • Length of Study: Several months to 2 years
  • Purpose: Efficacy and side effects
  • Approximately 33% of drugs move to the next phase

Phase 3

  • Study Participants: 300 to 3,000 volunteers who have the disease or condition
  • Length of Study: 1 to 4 years (< 1 year for Fast Track approvals)
  • Purpose: Efficacy and monitoring of adverse reactions
  • Approximately 25-30% of drugs move to the next phase

Phase 4

  • Study Participants: Several thousand volunteers who have the disease/condition
  • Purpose: Safety and efficacy

In some cases, such as with mRNA-1273, the FDA will award fast track designation. Fast track is designed to accelerate drugs and vaccines through development and review cycles with the intent to introduce them sooner to those in need. In future posts, we will discuss in further detail what fast tracking means to drug and medical device manufacturers and how they prepare for commercialization, which includes the need to onboard software vendor and data provider data for strategic planning and analysis. Fast tracking is also one of the reasons why Lore IO introduced the COVID-19 Data Onboarding Initiative to help pharmaceutical and medical device organizations that are developing products to fight COVID-19.

Updated: Wednesday, May 6, 2020

Numbers this week (as of May 5, 2020 10:00pm PDT):

COVID-19 Drug Pipeline Dashboard
Click to interact with our COVID-19 drug dashboard.

As of this week, over 3.7 million people globally have been infected and over 260,000 have died (source: Worldometer).

  • Death rate is at 17% globally (Total deaths as % of Total closed cases to date)

So far, more than 1.2 million patients have recovered and another 2.2 million are being treated.

  • Recovery rate is 83% (total recovered as % of total closed cases)
  • Only 2% of total active cases are currently serious or critical

The United States makes up approximately 33% (more than 1.2 million) of confirmed infections and 28% (more than 72,000) of total COVID-19-related deaths.

  • Death rate in the USA is currently 27% (compared to 17% worldwide)
  • Recovery rate in the USA is currently 73% (compared to 83% worldwide)

Few states are opening up, while others are easing restrictions. However, we are far from declaring that the virus is gone or can be prevented.

Drug pipeline and approvals

The FDA has created a special emergency program for potential therapies, the Coronavirus Treatment Acceleration Program (CTAP).

Last week, the following companies made significant progress towards the treatment:

The FDA issued an Emergency Use Authorization for remdesivir, by Gilead: On May 1, 2020, FDA issued an emergency use authorization for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. While there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, the investigational drug was shown in a clinical trial to shorten the time to recovery in some patients.

  • Severe COVID-19 is defined as patients with an oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO), a heart-lung bypass machine.
  • On March 28, 2020, the FDA had issued an EUA to allow hydroxychloroquine sulfate and chloroquine phosphate products to be distributed and used for certain hospitalized patients with COVID-19.

BerGenBio’S Bemcentinib selected to be fast-tracked as potential treatment for COVID-19 through new national UK government clinical trial initiative.

Diagnostics updates:

  • During the COVID-19 pandemic, the FDA has worked with more than 385 test developers who have said they will be submitting EUA requests to the FDA for tests that detect the virus.
  • To date, the FDA has issued 59 individual EUAs for test kit manufacturers and laboratories. In addition, 25 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).

Updated: Thursday, April 30, 2020

This week, we continue to extend our gratitude to all the hardworking healthcare professionals and researchers who have made a significant impact on the number of patients who have recovered from COVID-19. Keep up the great work! We salute you!

A salute to Dr. Uma, a hero, who cured more than 200 covid 19 patients working more than 18 hours a day.

Summary of updates this week:

  • As of this week, over 3.2 million people globally have been infected and over 230,000 (up from 170,000) have died.
  • The United States makes up approximately 33% (more than 1 Million) of confirmed infections and 27% (more than 60,000) of total COVID-19-related deaths.
  • So far, more than one million patients (up from 700,000+ last week) have recovered and another two million are being treated.

Two key headlines this week:

1. Do we see faster recovery with Remdesivir?

“It is a very important proof of concept, because what it has proved is that a drug can block this virus,” Dr. Fauci said. “This is very optimistic.” Dr. Fauci cautioned that the results of the study still needed to be properly peer reviewed. [New York Times]

The trial sponsored by the National Institute of Allergy and Infectious Diseases enrolled 1,063 patients who were given Remdesivir or a placebo. The time to recovery averaged 11 days among those who got the drug, compared with 15 days for those who got the placebo.

There were fewer deaths in the Remdesivir group, but the result did not reach statistical significance, Dr. Fauci said. Deaths were not a primary measure in the trial.

2. Will we have a vaccine by September 2020?

Oxford University is claiming that they would have a vaccine for COVID-19 by September 2020. Scientists at the university’s Jenner Institute schedule tests of their new coronavirus vaccine involving more than 6,000 people by the end of next month, hoping to show not only that it is safe, but also that it works. [New York Times]

The Serum Institute of India said on Tuesday it plans this year to produce up to 60 million doses of a potential vaccine against the new coronavirus that is under clinical trial in Britain. Serum, the world’s largest maker of vaccines by volume, is mass-producing the vaccine candidate developed by the University of Oxford, which started testing it on humans last week, and is a leader in the global race to develop an antidote to the novel coronavirus. [New York Times]

Original post: April 22, 2020

As we are all locked down safely in our homes, there are thousands of healthcare professionals and researchers working at the forefront to help COVID-19 patients. So far, more than 700,000 patients have recovered and another 1.7 million being treated right now. Some of the patients have been administered drugs that are in clinical trials, with few showing positive results. In this article, we’ll discuss the drugs and vaccines that are currently in the pipeline.

First detected in Wuhan, China at the end of 2019, the COVID-19 coronavirus now impacts communities around the world. As of April 21, over 2.5 million people globally have been infected, and over 170 thousand have died. The United States makes up about 30% of confirmed infections and approximately 20% of total reported COVID-related deaths. As COVID-19 continues to spread, research organizations and pharmaceutical companies are racing to uncover the keys to combating the lethal virus and developing an effective vaccine.

What do we know about COVID-19 and how it infects people?
COVID-19 is a type of coronavirus discovered in 2019 that causes an infectious disease in people. The virus predominately spreads via airborne droplets (from the nose or saliva) when an infected person sneezes, speaks, or exhales.  Individuals infected with COVID-19 will experience symptoms 2-14 days after initial exposure that may include: 

  • Fever
  • Cough
  • Difficulty breathing
  • Chills
  • Muscle pain
  • Headache
  • Sore throat
  • New loss of taste or smell

Some infected individuals, however, may be contagious while not showing symptoms.According to current patient data, most people infected with COVID-19 experience mild to moderate respiratory illness and recover without special medical treatment. Older people and individuals with underlying medical conditions (e.g., cardiovascular disease, diabetes, chronic respiratory disease, cancer, etc.), however, are more likely to develop severe illnesses.

As of April 21, there are no FDA-approved specific vaccines or treatments for COVID-19. Numerous clinical trials for treatments and vaccines are currently underway to improve patient outcomes and  curb the spread of the virus.

What treatments are available for patients infected with COVID-19?
There are no FDA-approved treatments for COVID-19, though research groups and pharmaceutical companies around the world are racing to identify effective therapies.  Some groups are aiming to repurpose drugs that have already been shown to be effective against related coronaviruses. One research group in China, identified 30 potential therapeutic candidates for repurposing for treatment of COVID-19 patients. Earlier this month, the World Health Organization (WHO) was joined by over 70 countries in the launch of its own clinical trial named “Solidarity” The trial aims to evaluate several potential treatments for COVID-19. Until sufficient evidence is compiled, physicians and medical associations have been cautioned against treating patients with unproven treatments. Below is a status summary of current COVID-19 treatment clinical trials as of 4/18.

Are there vaccines available for COVID-19 yet?

At present, there are no approved vaccines for the COVID-19 virus. Early development is underway for 109 vaccine candidates, and 7 vaccine candidates have begun clinical trials.

How can testing help to contain the spread of COVID-19?

Research surrounding infection rates and progression of COVID-19 disease suggests that infected individuals are most contagious during the early stages of infection--when symptoms may be at their most mild. This means that people can spread COVID-19 before they know they are infected. As follows, monitoring virus activity through coordinated testing and public health surveillance efforts  is key for preventing future community spread. 

Lack of testing in many parts of the US is a key challenge for addressing the current COVID-19 outbreak. Limits on who can get tested has largely been due to scarcity of approved COVID-19 testing kits. As of April 15, approximately 120,000 samples are  tested daily--though it’s estimated millions of people will need to be tested to corral the virus and return to normal. With non-essential businesses shuttered and stay-at-home orders issued in more than 40 states,  many are anxious about how much longer COVID-19 quarantine will last.

From the West to East Coasts, governors are considering gradually reopening their states after April dependent on health outcomes in their respective regions. Healthcare and business leaders have also stated that a gradual opening and return to economic normalcy will depend on public health surveillance to determine how extensive COVID-19 is in individual communities. To address this need, over 300 test developers have worked with the FDA to prepare kits subject to FDA emergency use authorizations (EUAs) that allow for emergency diagnostic testing for COVID-19.  The FDA has issued 41 EUAs for commercial diagnostic tests  and 16 EUAs for laboratory-developed tests that are designated to only be used in the academic or diagnostic laboratories that developed them.

Summary: What is the current future outlook for the COVID-19 drugs and vaccines?

  • First drug approved for COVID-19 is Favilavir, for experimental use in China, Italy & Japan.
  • All the Covid-19 vaccines are in early clinical trials (Phase 1 or 2) with the first set of results coming in late 2020 or early 2021.
  • In the Repurposed Drug category, Hydroxychloroquine is being tested in multiple clinical trials with mixed results.
  • In Investigational Drugs for COVID-19, Remdesivir has multiple clinical trials in Phase 3, and results are expected in coming months.

Check back weekly to find out how close we are to getting new drugs and vaccines to fight COVID-19.

News: Lore IO Announces COVID-19 Data Onboarding Initiative to Accelerate Time-to-Market for Pharmaceutical Companies Working to Combat Coronavirus

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