Our Statement on COVID-19
Our Clinical Programs
Arginase 1 Deficiency
When it became clear that COVID-19 would have a significant impact on the global healthcare system, we implemented a plan to minimize the potential impact on PEACE, our pivotal Phase 3 trial in Arginase 1 Deficiency.
We are communicating with our investigators on how to manage patients who are already enrolled but are unable to come to the hospital for their scheduled doses, and we are working on a plan to analyze results for patients who are missing data points. We are creating individual patient plans in consultation with the treating physician to ensure each patient receives the care most appropriate to their specific needs and the current capabilities of the hospital, and also are working on a plan to provide home healthcare for many of our trial participants to reduce the number of hospital visits required.
Additionally, we designed flexibility into our trial protocol that allows for a patient to miss a few doses without disqualification from the trial. That flexibility has allowed investigators to make decisions based on each individual participant’s personal situation and hospital resources, while maintaining the integrity of the trial.
As announced in April 2020, we received approval of our Clinical Trial Application (CTA) from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) for AGLE-177, a novel engineered human enzyme therapy designed to treat homocystinuria. The protocol for our Phase 1/2 clinical trial calls for numerous hospital visits, which may be a challenge to safely achieve given the current burden on hospital resources and prevalence of COVID-19 at this time. While our patient identification and administrative activities continue in support of our Phase 1/2 clinical trial, our priorities are to minimize the risk of trial participants being exposed to the novel coronavirus and to avoid further overburdening hospital staffs. We are closely monitoring the situation with COVID-19 and will be prepared to dose patients once circumstances permit.
Supporting Our Workforce
We have implemented several measures to do our part to slow the spread of COVID-19 and to protect the health and wellbeing of our employees.
- We have asked all employees to work from home with the exception of employees that are essential to maintaining our lab work.
- We have implemented a schedule to rotate employees through the lab to ensure appropriate social distancing while essential projects are maintained.
- We have enhanced cleaning procedures in our lab to help protect those that continue to work onsite.
- We conduct all meetings virtually, both internally and with external partners.
- We have suspended all business travel, including all in-person attendance at conferences and industry events.
This business update includes forward-looking statements based on our current expectations and beliefs that are subject to risks and uncertainties. Our actual results may differ materially. Please consult the risk factors section of our SEC filings, including our supplemental COVID-19 risk factor in our Form 8-K filed with the SEC on April 8, 2020.