— Phase 2b trial enrolled 678 participants in six months
— Topline data from Phase 2b head-to-head trial of CRV‑101 against Shingrix® expected in early 2023
SEATTLE, Sept. 15, 2022 /PRNewswire/ — Curevo Vaccine (Curevo), a privately held clinical-stage biotechnology company dedicated to reducing the burden of infectious disease by developing safe and highly-effective vaccines, today announced completion of enrollment in a Phase 2b trial of their CRV-101 subunit vaccine to prevent the reactivation of the varicella zoster virus (shingles) in older adults. CRV-101 is in development to be a potentially well-tolerated, highly effective shingles vaccine with high-yield manufacturing.
The Phase 2b trial enrolled 678 participants across eleven U.S. sites, randomized to a high- or low-dose CRV-101 arm or Shingrix. Participants received two doses, two months apart as per current practice for a shingles vaccine. Eligibility criteria included adults over 50 with no prior varicella zoster virus vaccination or history of shingles and were broadly representative of the potential non-immunosuppressed patient population for a shingles vaccine. The primary endpoints focus on safety and immunologic outcomes, including the occurrence of local and systemic side effects, antibody levels at month three, comparison of the reactogenicity of CRV-101 to Shingrix, and the occurrence of serious adverse events. Patient enrollment started in February 2022 and topline data from this Phase 2b trial are expected in January 2023.
“Shingles is a widespread viral disease that can lead to unrelenting, lifelong pain and debilitation,” said Dr. Jason Haffizula, MD, with Precision Clinical Research and an investigator on the Phase 2b trial. “There is a clear need for a new vaccine with lower side effects and equivalent or better efficacy.”
“Curevo’s ability, as a small private company, to enroll an average of over 100 patients per month is a testament to the enthusiasm amongst healthcare professionals and older adults for a potentially better-tolerated shingles vaccine,” said George Simeon, Curevo’s CEO. “Curevo is a lean company with a sharp focus on bringing varicella zoster vaccines with high manufacturing yields quickly and efficiently to market. I would like to extend my sincere appreciation to the trial investigators, their teams at the clinical trials sites, and especially participants in this trial.”
“Rapid enrollment of a large trial quickly in a challenging research environment during the pandemic is a credit to our nimble clinical operations and project management team,” said Lisa Shelton, ARNP, Curevo’s Director of Clinical Operations and Development. “The innovative measures we took to reduce key risks to enrollment worked were successful, and we look forward to applying these measures to Curevo’s future clinical programs.”
Shingles is a serious medical condition involving a very painful skin rash where 10-18% of people also develop serious, long-lasting nerve pain significantly impacting quality of life. Shingrix, the leading marketed shingles vaccine, posted approximately $2.1 billion in sales in 2021 despite being associated with activity-limiting side effects experienced by one in six (16.6%) adults. Analysts predict a worldwide shingles vaccine market opportunity of nearly $6 billion when manufacturing-based product shortages can be addressed.
The CRV-101 Phase 2b trial was based upon a prior successful Phase 1 healthy volunteer study which enrolled 18–50-year-old participants. In the Phase 1 study, CRV-101 was well tolerated along with robust humoral and cellular immunogenicity. Data from the Phase 2b trial will guide the design of a global Phase 3 program expected to begin in 2023, focused on achieving rapid initial approvals in multiple jurisdictions worldwide.
CRV-101 is a clinical-stage adjuvanted subunit vaccine under investigation for the prevention of shingles in older adults. CRV-101 was specifically designed with a goal of producing an optimal immune response while using a smaller amount of adjuvant with the goal to create a vaccine with good tolerability and a similar efficacy profile. CRV-101 enjoys a highly scalable, straightforward manufacturing profile designed specifically to eliminate the potential for supply disruptions.
About Curevo Vaccine
Curevo is a privately held clinical-stage biotechnology company based in Seattle and dedicated to reducing the burden of infectious disease with the objective of developing safe and highly effective vaccines via its subunit vaccine technology platform. Its lead product is CRV-101, a subunit vaccine to prevent the reactivation of the varicella zoster virus (shingles) in older adults. Shingles is a serious medical condition involving a blistering skin rash where 10-18% of people also develop serious, lasting nerve pain. Curevo’s objective is to supply the projected $6 billion shingles global vaccine market with an alternative shingles vaccine. Cuervo is also developing a non-live, subunit chickenpox vaccine. For more information visit https://curevovaccine.com/.
Shingrix® is a registered trademark of GlaxoSmithKline, PLC.
SOURCE Curevo, Inc.