Seres’ Statement on COVID-19
Seres has been closely monitoring the evolving impacts of COVID-19, taking all necessary precautions to help ensure the safety of employees and contractors, the well-being of clinical trial researchers and patients, and the continuity of our ongoing business operations.
Patients & Physicians
We recognize that there is much concern about several FDA safety alerts in recent months related to fecal microbiota transplant (FMT) and the risk of pathogen transmission, including warnings related to multi-drug resistant bacteria and SARS-CoV-2, the virus linked to COVID-19 (June 12, 2019 Alert; March 12, 2020 Alert; and March 23, 2020 Alert). These safety alerts have no impact on our investigational therapeutic candidates, which are fundamentally distinct from FMT and from other microbiome therapeutics currently in clinical studies.
In contrast to FMT, SER-109 and SER-287 are comprised of a highly purified consortia of spore-based commensal bacteria and are processed under Good Manufacturing Practices (GMP) conditions using stringent standards to ensure product quality and consistency. Our rigorous manufacturing process has been demonstrated to inactivate numerous potential pathogens, including species of non-spore bacteria and viruses, including many emerging potential pathogens where diagnostic assays may not yet be available, such as SARS-CoV-2. These manufacturing processes provide a critical layer of protection for patient safety that cannot be achieved by donor screening alone. They minimize patient risk by providing a safety net against new infections, such as COVID-19, even before pathogens are detectable. For more information, see our position statement highlighting the critical contribution of pathogen inactivation processes in the manufacture of microbiome therapeutics.
Seres is also developing product candidates such as SER-301, which are consortia of bacterial cells that have been fermented in pure culture; these cultivated consortia are designed to provide essential metabolic functions required for drug potency, while mitigating risk to patients.
For patients in our clincial trials: We are working closely with your site to reduce disruptions caused by COVID-19 and encourage you to contact your site team to understand the status of your upcoming visits.
Employees & Contractors
As the COVID-19 situation continues to evolve, we remain on high alert, responding quickly as developments occur. Seres Therapeutics has assembled a COVID-19 response team composed of senior leaders that is dedicated to assessing the situation and executing mitigation activities. We are closely monitoring the outbreak and its impact on employee safety and business operations. We are supporting our clinical sites with the resources needed to continue to protect their employees and meet the needs of patients. Though our facility remains open for critical manufacturing operations, most of Seres’ employees are working remotely.
For our essential laboratory and manufacturing personnel, we are actively following the latest World Health Organization (WHO) recommendations and standards of personal care and hygiene to minimize potential exposure.
Ongoing Clinical Development
We continue to evaluate the impact of COVID-19 on our clinical studies and have implemented measures that seek to maintain the advancement of our clinical development candidates while also safeguarding the well-being of our clinical study site staff and the patients enrolled in our studies. We issued a press release on March 30, 2020 with updates on our programs.
We wish everyone health and safety in these challenging times.
Eric Shaff, CEO & Seres leadership team
April 7, 2020
This statement contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements that do not relate to matters of historical fact should be considered forward-looking statements, including statements relating to the impact of the COVID-19 pandemic and the safety and purity of our product candidates. Any forward-looking statements represent management’s opinions as of April 7, 2020, should not be relied upon as representing management’s views as of any date thereafter, and we disclaim any obligation to update statements in the future, even if subsequent events cause our views to change. These forward-looking statements are subject to important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 2, 2020 and our Current Report on Form 8-K filed with the SEC on March 18, 2020.