In a significant stride toward combating the evolving challenges of the COVID-19 pandemic, Juniper Therapeutix, a leading science-led healthcare company based in Singapore, has secured exclusive licensing rights for Ensitrelvir Fumaric Acid (“Ensitrelvir”) from Ping-An Shionogi Hong Kong, a group company of Shionogi & Co., Ltd.
This groundbreaking antiviral drug, which has already received emergency regulatory approval in Japan, marks a pivotal advancement in the fight against COVID-19.
Clinical Symptomatic and Antiviral Efficacy
Ensitrelvir is a 3CL protease inhibitor developed through collaborative research between Hokkaido University and Shionogi. It has demonstrated clinical symptomatic efficacy for five typical Omicron-related symptoms and antiviral efficacy in patients with mild to moderate SARS-CoV-2 infection. This dual action makes it a trailblazer in the realm of COVID-19 therapeutics, addressing both the symptoms and the underlying viral replication.
Private Patient Access Application with Health Sciences Authority (HSA)
Juniper Biologics, the parent company, has promptly applied for private patient access with the Health Sciences Authority (HSA) of the Republic of Singapore. The application targets the indication of SARS-CoV-2 infection, showcasing the commitment of Juniper Therapeutix to expedite the availability of Ensitrelvir to patients in need.
Strategic Partnership with Shionogi
Raman Singh, CEO of Juniper Biologics, emphasized the strategic importance of the partnership with Shionogi, stating, “Ensitrelvir stands as a critical tool to manage cases effectively, providing an extra layer of support and care in our ongoing battle against this ever-evolving virus.” The collaboration involves Ping An-Shionogi Hong Kong and the wider Shionogi Group working closely with Juniper Therapeutics to facilitate the approval process and subsequent commercial launch in Singapore.
Global Clinical Development Program
Ensitrelvir’s journey doesn’t end with this licensing agreement. Shionogi has a comprehensive, global clinical development program in progress, including four Phase 3 trials. SCORPIO-HR, a trial for non-hospitalized, symptomatic COVID-19 patients, is among the pivotal studies, exploring the potential impact of Ensitrelvir on both acute symptoms and the symptoms of long COVID. Shionogi is also conducting SCORPIO-PEP, evaluating the safety and efficacy of Ensitrelvir for the prevention of symptomatic SARS-CoV-2 infection.
This collaboration represents a significant leap forward in the quest for effective COVID-19 therapeutics, offering hope for the rapid recovery and improved management of infected patients in Singapore and potentially worldwide.