ReiThera Completes Enrolment of Subjects in the Phase 2 Part of the Phase 2/3 Clinical Trial of its GRAd-COV2 Vaccine Candidate against COVID-19
ROME, Italy, April 26th, 2021 – ReiThera Srl, a biotech company dedicated to the technology development, GMP manufacturing and clinical translation of genetic vaccines and medicinal products for advanced therapies, announces that it has completed the enrolment of 900 healthy volunteers in the Phase 2 part of its Phase 2/3 clinical trial of GRAd-COV2, its vaccine candidate against COVID-19 (SARS-CoV-2). The study, named COVITAR (GRAd-COV2 ITAlian Vaccine Reithera), is being conducted at 26 clinical sites in Italy.
ReiThera’s Chief Executive Officer, Antonella Folgori, said: “We have seen a strong participation in the Phase 2 study, thanks to the commitment of the clinical centers and all the investigators involved in the study. We would also like to thank Invitalia and INMI Spallanzani for their continued support and in particular ReiThera’s teams for their dedication and hard work over the past few months. We are committed to continuing the development of the GRAd-COV2 vaccine and if all proceeds as planned, we expect to conduct the Phase 3 part of the trial over the summer.”
Stefano Colloca, Chief Technology Officer of ReiThera, added: “ReiThera is in an excellent position to address the COVID-19 challenge. In 2020, we invested in the expansion of our manufacturing plant in Rome which will have the capacity to produce up to 100 million vaccine doses per year. In parallel, and as part of an effort stimulated by the Italian government, we have the know-how and production capacity available to respond positively to any requests for the production of other approved COVID-19 vaccines based on mRNA and adenoviral vectors, as part of our commitment to the global effort to protect people from the pandemic.”
About the COVITAR Trial
COVITAR (GRAd-COV2 ITAlian Vaccine Reithera) is a Phase 2 trial in 900 participants who are randomized 1:1:1 to receive a single dose, two doses or placebo, with vaccine or placebo being administer on Day 1 and Day 22. The trial is being conducted at 26 sites in Italy. The Principal Investigator for the trial is Dr. Simone Lanini at the Istituto Nazionale per le Malattie Infettive (INMI) Lazzaro Spallanzani in Rome.
An Independent Data Safety Monitoring Board and Steering Committee will make its recommendation to expand to the Phase 3 part of the study and the vaccine schedule (single or double dose) to be used. The recommendation will be based on safety results and immunogenicity data after monitoring participants for five weeks from the first vaccination in the first 450 participants enrolled (approximately 150 subjects per study arm).
The Phase 3 trial will have an adaptive design to account for the evolution of the COVID-19 pandemic, the availability of approved vaccines and characteristics of ongoing vaccination campaigns.
ReiThera will base its decision on guidance from the European Medicines Agency (EMA) on the most appropriate clinical development plan to be implemented in countries where authorized vaccines are being rolled-out.
About ReiThera Srl
ReiThera Srl is a biotech company dedicated to the technology development, GMP manufacturing and clinical translation of genetic vaccines and medicinal products for advanced therapies. The company’s management and scientific teams have developed a highly innovative technological platform based on simian adeno-vectored vaccines against several infectious diseases, such as RSV and Ebola.
ReiThera is led by an experienced management team that has worked together for many years in previous successful enterprises, including Okairos (acquired by GSK), and has a long-standing expertise in scalable processes for viral vector manufacturing, supported by a cGMP facility inclusive of filling suite and quality control laboratories.
ReiThera has its headquarters, R&D laboratories and GMP facilities in Rome, Italy.
For further information see: www.reithera.com
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