Parexel Biotech, a division of drug development services firm Parexel, has entered into a strategic collaboration with Synairgen, a respiratory treatment development firm. The two will collaborate on conducting a Phase III study of SNG001, in inhaled formulation of an interferon beta (IFN-beta) treatment intended for patients hospitalized with COVID-19.
The study is designed to evaluate SNG001’s ability to accelerate recovery among hospitalized COVID-19 patients that are receiving oxygen. According to the companies, the randomized, double-blind, placebo-controlled trial aims to enroll 900 patients across about 20 countries.
Outsourcing-Pharma (OSP) recently spoke with Bertrand Sohier (BS), senior vice president and global therapeutic area head for general medicine with Parexel, about the SNG001 trial and the challenges of conducting clinical research during a pandemic.
OSP: Could you please tell us a little bit more about SNG001, and how it came to be investigated as a potential COVID-19 therapy?
BS: SNG001 is an (IFN-beta) directly administered in the lung by nebulization. Interferons have been used for many years as antiviral treatments.
Historically, interferons have been part of anti-hepatitis-C treatment and have likely saved millions of lives. Our bodies produce interferons in response to viral infections, so it is an innate, natural antiviral compound. They protect cells from viral infection and inhibit or decrease viral replication through several mechanisms.
Therefore, it comes as no surprise 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 achieve very high concentration within the airways.
Because COVID-19 is first and foremost an airway disease, it comes in either through the nose or the lungs, so achieving 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 partnered on projects in the past?
BS: When the pandemic struck, Synairgen was quick to respond and so was Parexel. We rapidly adapted traditional trials to include decentralized trial approaches that allowed patients to continue participating in trials from home, using telemedicine, direct-to-patient drug shipments, wearables, smartphone apps and other digital technology in place of in-person visits to the clinic.
Our quick response to the pandemic and our global outreach—coupled with our biotech expertise—were the right combination for many customers who were developing COVID therapies, so we quickly began partnering on a large number of studies – more than 130 COVID-19 programs at present. Because Parexel has a strong reputation in the COVID area, we were an attractive partner for Synairgen for our first collaboration.
OSP: Could you tell us a little bit more about Parexel Biotech’s contributions to this trial?
BS: This is a complex field that is evolving every day, and global health authority guidelines are evolving as new learnings come to light and new therapies are demonstrating efficacy. Our regulatory experience and the solidity of our processes and field knowledge are key elements of our partnership with Synairgen.
We’re able to apply our operational experience regarding the way COVID is treated in India or the U.S. or Europe, for example, to ensure we can seamlessly navigate their respective in-country requirements. In addition, very practical considerations such as what is the best scale to report COVID-19 symptoms can take on great importance in these trials, and we apply these practical learnings across other trials.
Our close relationships with sites—knowing their constraints and their expectations—and our ability to translate scientific vision into a pragmatic, attractive operational project are clearly instrumental. Sites and site networks have become very selective in the trials they accept, so our ability to convince sites one by one of the medical interest of this trial for their patients is critical.
OSP: Could you please tell us some of the challenges presented to running a trial (COVID-19 related or otherwise) during a pandemic, and how you’re addressing them for this trial?
BS: One of the main challenges is reducing the burden of work on the investigational sites. Each time we think about a procedure in this type of trial, we have to think about the level of burden on the patients, the sites and the impact on trial timelines. More than ever, in this frantic race for an effective treatment, we have to balance the “nice to have” procedures with the critically important ones for the scientific and regulatory validity of the trial.
At times, we have to make difficult decisions about what should be done and, more importantly, what should not be done. We also have to consider minute details that can have a big impact.
For example, the practicality of using a nebulized drug raises the question of whether this could spread the virus into the room as small droplets are being inhaled and exhaled. We know the virus is contained within droplets, so the more you exhale droplets, the more it is spread.
We must ensure that we have the right controlled environment and the right investigators to carry out the trial, or we can end up with inconclusive or inaccurate results. Controlling for this complexity is a very real challenge.
