FDA Continues to Accelerate Development of Novel Therapies for COVID-19

Companies Taking Very Different Approaches to ACE2-Focused COVID-19 Therapies

ACE2, which stands for angiotensin-converting enzyme-2, in healthy people, cuts up to two forms of the angiotensin protein to stabilize blood pressure, as well as other functions. SARS-CoV-2 attaches to ACE2, letting itself into the cell, where it then replicates itself in the cell. Usually, ACE2 is found on the lung, kidney, heart, and gut cells. Recently, researchers discovered ACE2 receptors on the cells in the nose.

At least three different biotech companies are working on two ACE2-related drugs to find a solution to the COVID-19 pandemic. They are Vienna, Austria’s APEIRON Biologics, Cambridge, Massachusetts-based Alnylam Pharmaceuticals, and San Francisco-based Vir Biotechnology.

Apeiron’s approach is to flood the body with more ACE2 to confuse the virus. On April 2, the company received the go-ahead from regulators in Austria, Germany, and Denmark to launch a Phase II trial of APN01 to treat COVID-19. APN01 is the recombinant form of the human angiotensin-converting enzyme 2 (rhACE2), which, the company indicates, has the potential to block the infection of the cells by SARS-CoV-2, decreasing lung injury. The trial plans to treat 200 severely infected COVID-19 patients.

Vir and Alnylam’s overall approach is to silence a protein that causes a disease that is the result of an overproduction of the protein. In the case of COVID-19, the focus is on silencing the ACE2 receptor, with the rationale that without it, the virus won’t be able to infect cells.


FDA Continues to Accelerate Development of Novel Therapies for COVID-19

There are a large number of companies and researchers developing and evaluating COVID-19 related therapies. Given the urgent nature of the pandemic, under the FDA’s accelerator program, staff from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research is providing regulatory advice, guidance and technical assistance as quickly as possible. As part of this work, the FDA is triaging requests from developers and scientists seeking to develop a new drug and biologic therapies, getting the relevant FDA staff in touch with them and providing rapid, interactive input to get studies underway quickly. For example, the FDA has reviewed study protocols within 24 hours in many cases and has reviewed single-patient expanded access requests generally within three hours. The FDA is also collaborating with federal partners, developers and researchers to create protocols that can be used across institutions and programs to streamline efforts.

The FDA also recognizes the potential for many different real-world data sources to complement traditional clinical studies and speed the process of evaluating the impact of potential COVID-19 therapies. To that end, the agency is advancing relationships with partners in the public and private sectors to rapidly collect and analyze information in areas such as illness patterns and treatment outcomes.


Feinstein Institutes to Collect COVID-19 Patient Plasma, Research Antibodies Therapy

The Feinstein Institutes will initiate a clinical trial to investigate the therapeutic benefit and safety of donated plasma that contains antibodies to SARS-CoV-2 (the virus that causes COVID-19) from a convalescent – someone who has recovered from the virus. Plasma carries blood components within the human body and, when separated, is a light yellow liquid. This plasma will be injected into someone who is being hospitalized with COVID-19 and being treated at North Shore University Hospital (NSUH) or Long Island Jewish Medical Center (LIJ), in hopes the infused antibodies will ward off infection. Additional Northwell Health hospitals will be able to administer plasma soon.

Additionally, for Feinstein Institutes scientists to better understand the immune system response to COVID-19 for future research, including the investigation of a potential vaccine, those who visit the Convalescent Coronavirus Patient Registry at Northwell.edu/CombatCOVID will be urged to consent and participated in future ongoing research projects at the Feinstein Institutes.


Boris Johnson improving and sitting up in bed, chancellor says

United Kingdom: Boris Johnson remains in intensive care in the hospital but has shown signs of improvement. The Prime Minister is reported to be sitting up in bed and “engaging positively” with the clinical team, the chancellor Rishi Sunak said in a daily media briefing yesterday evening.


Healx will use AI to seek combination therapies to treat COVID-19

Healx is working to accelerate the discovery and development of therapies for rare diseases that exist without treatment options. This includes cystic fibrosis, Alström syndrome, and other conditions relating to the heart and respiratory system that can put patients in the at-risk category if they develop COVID-19.

The start-up said that combination therapies can be particularly difficult to discover. To uncover potential combination treatments for COVID-19 requires a detailed analysis of the 8m possible pairs and 10.5bn drug triples stemming from the 4,000 approved drugs already on the market.

Healx’s platform, Healnet, aims to overcome this challenge by integrating and analyzing biomedical data from multiple sources to predict combination therapies that are most likely to succeed in the clinic.

The company said that the development of combination therapies is one of its “core strengths” and combination therapy candidates for treating COVID-19 will be available in May for preclinical testing.


Microneedle patches for potential COVID-19 vaccines or therapeutics   

These patches were recently put to use for testing out the PittCoVacc, and were initially developed by the University of Pittsburgh Medical Center as well as Carnegie Mellon University. Now, Ozdoganlar says he is looking for scientists to work with him on developing a therapy or a vaccine for the SARS-CoV-2 that is causing the current pandemic. Describing the nature of the collaboration, he says, “My lab can fabricate hundreds of microneedle arrays with your viable vaccine or antiviral drug very quickly for testing in your vaccine and drug development, and we can ramp up to thousands if needed.”                 

And the offer goes beyond the experimental stage. The investigator says his group can help with the manufacture of a proven vaccine once it is identified. Throwing the weight of his formidable expertise and experience with the microneedle arrays, as well as promising to use his connections to achieve the best possible output, he says, “We can provide the necessary expertise, experience, and connections to scale up the manufacturing of the vaccine patches using Good Manufacturing Practice (GMP) guidelines to the levels that will effectively address the COVID-19 vaccination needs.”