Dicerna Addresses Business Continuity in Response to COVID-19 Pandemic
Mar 26, 2020
“The COVID-19 crisis reminds us that the health and safety of our people, clinical trial participants and our communities is our first priority. Like many other companies in drug development, a number of our clinical trial sites are temporarily postponing or suspending trial-related activities in the wake of COVID-19, impacting our clinical trial execution plans,” said
Patients and Clinical Trials
Dicerna conducts clinical trials in various countries around the world, including the
- PHYOX™2 Pivotal Trial of Nedosiran for Primary Hyperoxaluria (PH). Dicerna is instituting measures to ensure continuity of care and continued dosing of patients currently enrolled in the PHYOX2 trial. The Company is working closely with local Institutional Review Boards (IRBs) to implement a protocol amendment that would allow for the transition of remaining site visits to at-home nurse visits for drug administration and safety follow-up. Based on current enrollment and temporary suspension of further clinical trial activities at multiple sites, the Company no longer expects to complete enrollment in PHYOX2 in the second quarter of 2020 as previously projected. Given the fluid nature of the current situation, and the evolving and extraordinary actions undertaken by clinical trial sites globally, the Company is reevaluating the clinical plan, and at a later date, will provide a revised timing estimate for PHYOX2 enrollment completion, and evaluate its potential effect on timing of subsequent activities, such as the nedosiran New Drug Application submission.
- PHYOX3 Long-Term Multidose Trial of Nedosiran for PH. Unlike the PHYOX2 trial, which requires screening and enrollment of new patients, patients with PH are permitted to roll over into the PHYOX3 trial from any previous nedosiran trial in which they have participated. As with PHYOX2, Dicerna is working with local IRBs to implement a protocol amendment to facilitate transition of remaining site visits to home-based dose administration and safety follow-up and, at this time, expects that a modified protocol would enable the PHYOX3 trial to continue according to plan for most participants.
RG6346 Phase 1 Proof-of-Concept Trial for Hepatitis B Virus Infection. The Phase 1 clinical trial of RG6346 for the treatment of chronic hepatitis B virus (HBV) infection continues to progress as planned and is nearing the end of enrollment. Dicerna continues to expect to present Phase 1 proof-of-concept data from all existing cohorts at the Company’s R&D Day in
- DCR-A1AT Phase 1/2 Trial for Alpha-1 Antitrypsin Deficiency (A1AT). The initial enrollment of healthy volunteers has proceeded according to plan in Dicerna’s Phase 1/2 trial of DCR-A1AT. However, given the potential for increased respiratory risk from COVID-19 for future participants in this trial, the Company currently expects that a pause in enrollment at higher doses in the Phase 1/2 trial is likely, pending further developments in management of the COVID-19 situation.
R&D Day. Dicerna continues to plan to host an R&D Day event in
August 2020, either virtually or in person, as circumstances allow, with updates on nedosiran multidose data, RG6346 Phase 1 data and new data regarding the extension of the Company’s RNAi technology to additional tissues.
Due to the rapidly evolving circumstances, Dicerna is continuing to evaluate the impact to future studies of nedosiran and future activities in its other clinical trials and development programs. The Company expects to provide a further update when it announces its first quarter 2020 financial results.
Product Supply and Supply Chain
Supply of Dicerna’s investigational medicines is sufficient to support ongoing clinical trials. Based on current evaluations, Dicerna’s supply chains continue to appear intact at this time to meet the Company’s foreseeable 2020 clinical, nonclinical and chemistry, manufacturing and control (CMC) supply demands across all programs, but the Company is alert to the potential for disruptions that could arise from COVID-19 and remains in close contact with suppliers.
Dicerna continues to be well capitalized with approximately
Employees and Communities
Dicerna has instituted a mandatory work-from-home policy for the majority of its employees at each location to stem the spread of the COVID-19 virus and enable the continued health and safety of its work force. The duration of this remote working arrangement will be guided by the direction of the state governments in which Dicerna operates, and actions and guidelines issued by the federal government, including the
Due to the nature of Dicerna’s work and mission, essential-work exemptions continue to permit critical research and development and laboratory activities for limited personnel. Those exemptions enable some continued discovery research and activities supporting the Company’s collaborative agreements and Dicerna’s own programs. For these employees, Dicerna has established a set of safety guidelines to reduce close interactions, including flexible work schedules to limit the number of people on-site and use of personal protective equipment, which are intended to maintain the safety of employees, their families and communities.
Cautionary Note on Forward-Looking Statements
This press release includes forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Examples of forward-looking statements include, among others, statements we make regarding: (i) future conduct of the business of the Company, its clinical programs and operations in the face of the COVID-19 pandemic; (ii) the research and development plans and timelines related to the Company’s clinical programs and the opportunity to enroll, continue or resume clinical studies that are slowed or halted by the COVID-19 pandemic; and (iii) continued manufacture and supply of raw materials for the Company’s clinical and development programs, the availability of any of which could be significantly impaired by COVID-19. Applicable risks and uncertainties include those relating to Dicerna’s clinical research and other risks identified under the heading "Risk Factors" included in the Company’s most recent filing on Form 10-K and in other future filings with the
Cautionary Note on Future Updates
The statements contained in this press release reflect Dicerna's current views with respect to future events, which may change significantly as the global consequences of the COVID-19 pandemic rapidly develop. Accordingly, Dicerna does not undertake and specifically disclaims any obligation to update any forward-looking statements.
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