Keeping tabs on Covid-19: BetterLife embraces virtual clinical trials and Novan…

Clinical Trials & Research

As pharma companies search for solutions to avoid cancelling or delaying clinical trials, virtualizing trials are fast becoming commonplace during the Covid-19 pandemic. With many nationwide and regional lockdowns coming into force, virtual clinical trials are proving to be an effective way to monitor patients remotely.

This week’s round up features a digital solution for adapting clinical trials to ease the burden on the clinical research industry and an in vitro model that mimics the human airway epithelium using a newly developed technology platform.

BetterLife conducts patient centric study via a fully remote clinical trial

BetterLife Pharma, a Canadian-based biotech company, has announced it is joining forces with VirTrial, a decentralized and virtual clinical trial management platform, to transform its patient monitoring processes for an imminent Covid-19 clinical trial of AP-003 in Australia.

The partnership will allow BetterLife to empower its selected clinical research sites to perform virtual visits via a combination of secure video, audio, chat and messaging. All of these technologies can be used on a variety of devices. According to BetterLife, incorporating virtual visits will facilitate the company to evaluate, qualify and routinely monitor both patients and research sites for studies without physical travel, ensuring patients will able to participate in clinical trials in their own homes.

Dr. Ahmad Doroudian, CEO of BetterLife, said: “’It is exciting to know that we are making use of technology that allows us to safely deliver and monitor the efficacy of AP-003 to patients directly.

“Considering the constant changing restrictions on travel due to Covid-19, we felt that this was the best option for us to proceed without delay with our patient trials. We feel that partnering with an innovative company like VirTrial will assist us in virtually monitoring patients who may or may not be able to travel to our clinical sites owing to self-isolation at home.”

Mark Hanley, CEO of VirTrial commented: “The sites we work with are excited about the opportunity to be part of the solution for a true and present need, and appreciate the benefit of being able to conduct a patient-centric study via a fully remote decentralized clinical trial while eliminating any risk to employees.”

In vitro antiviral technology proves effective against SARS-CoV-2 in human airway infection model

Novan has been evaluating the ability of its NITRICIL platform technology as a potential nasal treatment option for Covid-19, announcing its potential efficacy as an antiviral against SARS-CoV-2, the virus that causes Covid-19.

To tests the technology’s efficiency, the company conducted in vitro assessments on normal human bronchial epithelial cells at the Institute for Antiviral Research at Utah State University. The results indicated the first instance of an antiviral effect from a nitric oxide-based medicine in a 3D tissue model which has similar a structure to the human airway epithelium.

Paula Brown Stafford, chairman and CEO of Novan, said: “Covid-19 continues to have a major ongoing impact on global health and there remains a direct need for a safe and effective antiviral therapy. The naturally occurring antiviral effects of nitric oxide and the results we have generated from this assessment, provide us with confidence that our NITRICIL platform technology may be an effective treatment for Covid-19. We also believe the data from this sophisticated model of the human respiratory tract demonstrate a high potential for clinical translation.”

Dr. Carri Geer, senior vice-president and CTO at Novan, added: “With these encouraging in vitro results in hand, the next step is to advance our program into preclinical IND-enabling studies to further confirm the safety of our NITRICIL technology when administered intranasally.

We are in the process of finalizing arrangements with a global leader in drug development to assist in our development activities as we work toward a potential IND filing targeted in 2021.”

Dive into real-life use case from GSK and the Clinical Trials Transformation Initiative to find out how to use technology to enrich and simplify the patient experience during a clinical trial. Download Medidata’s white paper to learn how to virtualize clinical trials and bring new therapies closer to patients.

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