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Parexel Biotech, a division of drug development services company Parexel, has entered into a strategic partnership with Synairgen, a respiratory treatment development company. The two will collaborate in the conduct of a Phase III study on SNG001, in the inhaled formulation of a treatment with interferon beta (IFN-beta) for hospitalized patients with COVID-19.
The study is designed to evaluate SNG001’s ability to accelerate recovery among hospitalized COVID-19 patients receiving oxygen. According to the companies, the randomized, double-blind, placebo-controlled trial aims to enroll 900 patients in around 20 countries.
Outsourcing-Pharma (OSP) recently spoke with Bertrand Sohier (BS), senior vice president and head of the global therapeutic area for general medicine with Parexel, about the SNG001 study and the challenges of conducting clinical research during a pandemic.
OSP: Could you tell us a little more about SNG001 and how it has been studied as a potential COVID-19 therapy?
BS: SNG001 is a (IFN-beta) administered directly into the lung by nebulization. Interferons have been used for many years as antiviral treatments.
Historically, interferons have been part of hepatitis C treatment and have likely saved millions of lives. Our body produces interferons in response to viral infections, so it is an innate and natural antiviral compound. They protect cells from viral infection and inhibit or reduce viral replication through several mechanisms.
Therefore, it is not surprising that interferon is being evaluated as a therapy for COVID-19. SNG001 was initially developed to reduce the rate of viral infection among COPD patients. It is nebulized to obtain a very high concentration within the airways.
Since COVID-19 is primarily an airway disease, it enters through the nose or lungs, so reaching a high concentration of interferon beta in the lungs has the potential to restore the lung’s ability to neutralize the virus and accelerate recovery in patients with COVID-19.
OSP: How did Synairgen and Parexel Biotech come to work together on this – have you collaborated on projects in the past?
BS: When the pandemic broke out, Synairgen was quick to respond and so was Parexel. We quickly adapted traditional trials to include decentralized trial approaches that allowed patients to continue participating in trials from home, using telemedicine, patient-directed drug shipments, wearables, smartphone apps, and other digital technologies to the place of in-person visits to the clinic.
Our rapid response to the pandemic and our global reach, coupled with our expertise in the biotechnology industry, were the right match for many clients developing COVID therapies, so we quickly began collaborating on a large number of studies – more than 130 COVID-19 programs to present. As Parexel has a solid reputation in the COVID area, we were an interesting partner for Synairgen for our first collaboration.
OSP: Can you tell us more about Parexel Biotech’s contributions to this process?
BS: This is a complex field that evolves every day and the guidelines of the global health authority are evolving as new teachings come to light and new therapies are proving effective. Our regulatory experience and the robustness of our processes and field knowledge are key elements of our partnership with Synairgen.
We are able to apply our operational experience regarding how COVID is treated in India, the United States or Europe, for example, to ensure that we can seamlessly navigate the respective national requirements. In addition, very practical considerations such as what is the best scale for reporting COVID-19 symptoms can be of great importance in these studies and we apply these practical teachings to other studies.
Our close relationships with the sites, knowing their constraints and expectations, and our ability to translate the scientific vision into a pragmatic and attractive operational project are clearly fundamental. Sites and site networks have become very selective in the trials they accept, so our ability to persuade sites one by one of the medical interest of this trial for their patients is paramount.
OSP: Could you tell us some of the challenges that arise in running a trial (related to COVID-19 or not) during a pandemic and how do you address them for this trial?
BS: One of the main challenges is reducing the workload on survey sites. Whenever we think about a procedure in this type of trial, we need to think about the level of load on the patients, the sites and the impact on the timing of the study. More than ever, in this frantic race for effective treatment, we need to balance the “nice to have” procedures with those of fundamental importance for the scientific and regulatory validity of the trial.
Sometimes, we have to make tough decisions about what should be done and, more importantly, what shouldn’t be done. We also need to consider the minute details that can have a big impact.
For example, the convenience of using a nebulized drug raises the question of whether it can spread the virus around the room as small droplets are inhaled and exhaled. We know that the virus is contained within droplets, so the more droplets you exhale, the more it spreads.
We need to make sure we have the right controlled environment and the right investigators to conduct the study, otherwise we may end up with inconclusive or inaccurate results. Controlling this complexity is a real challenge.
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