Shionogi Inc. (U.S.)

Today is an encouraging day for the Fragile X syndrome community. We are pleased to share an update on the progress of our?EXPERIENCE clinical trials (also known as BPN14770-CNS-204, BPN14770-CNS-301, BPN14770-CNS-302 and the Tetra studies): Enrollment for EXPERIENCE-301 (adult study in Fragile X syndrome) is near capacity and screening will close today. Clinical trial sites are no longer able to accommodate any new appointments, but they are working with Shionogi to accommodate previously scheduled appointments for potential new study participants. EXPERIENCE-204 (adolescent study in Fragile X syndrome) is in its final phase of enrollment. All scheduled screening appointments will proceed as planned; however, no additional screening appointments are available. Shionogi is sincerely grateful to the families who participated in these studies as well as the clinical trial investigators and staff who have led the research. We look forward to sharing the results from these studies and remain committed to the EXPERIENCE clinical program, including through EXPERIENCE-302 (open-label study), which is ongoing for individuals who have completed EXPERIENCE-301 and 204. Please contact [email protected]?or 1-800-849-9707?with questions.

Five years after the world shut down, COVID-19 still affects our lives. We have been exploring a way to potentially?prevent COVID-19 illness after exposure. Thank you?TIME?for reporting about SCORPIO-PEP,?our phase 3 study for our investigational oral antiviral: https://lnkd.in/exQNgEcz??

Urgent action is needed to address antimicrobial resistance (AMR), which disproportionately affects vulnerable populations, including older individuals. Economic policies like pull incentives are vital to ensure consistent funding and a predictable market to support the development of innovative antimicrobial products. See more recommendations to curb #AMR in the new outcomes report from the Global Coalition on Aging’s Silver Economy Forum: https://lnkd.in/ge8BX7Dp #SilverEconomyForum #SEF2024 #AntimicrobialResistance

SARS-CoV-2 continues to spread and there are still thousands of hospitalizations and hundreds of COVID-19 deaths each week. There are also continued concerns about the long-term effects of COVID-19 infections. Currently, there are no approved medicines to prevent COVID-19 in people who have been exposed to a person with SARS-CoV-2 infection. Last October, we shared topline data from our SCORPIO-PEP study, the first and only Phase 3 study of an?oral antiviral for post-exposure prophylaxis to meet the primary endpoint of preventing COVID-19, and yesterday we shared updates on our research at #CROI2025. https://lnkd.in/eHTdES7H

At #CROI2025, we presented data from the global Phase 3 SCORPIO-PEP study – the first and only Phase 3 trial of an oral antiviral to meet the primary endpoint of preventing COVID-19. Post-exposure prophylaxis is currently a gap in COVID-19 prevention. This achievement brings us another step forward in our journey of addressing unmet COVID-19 needs and ultimately helping to lessen the impact of certain infectious diseases. Read the release here: https://lnkd.in/eHTdES7H

The threat of bacterial resistance is a growing problem throughout the world and many problematic bacteria are continuing to become more resistant to currently available antibiotics, especially in some Asian countries. For example, in South Korea, the rate of carbapenem-resistant Enterobacterales (CRE) infections has grown by 20–30% every year since 2019. The marketing approval of our antibiotic for certain Gram-negative bacterial infections in South Korea is an important step in our ongoing work to address unmet medical needs for patients worldwide.? Read the release here: https://lnkd.in/eFu-tQ9P

This International Women’s Day, join us in celebrating the women at Shionogi – specifically our Shionogi Inc.'s Healthcare Businesswomen’s Association Rising Star and Luminary nominees – who are making a meaningful impact across science, business, patient health, and beyond, and leading the charge in healthcare innovation. The incredibly valuable contributions of these women span focus areas across our organization, from driving clinical research programs to leading strategic business analysis to excellence in mentorship?to creating immersive educational experiences, and are reflective of the culture here at Shionogi – one defined by collaboration, innovation and a shared commitment to making a meaningful difference in the lives of the patients and families we serve. We look forward to celebrating these achievements and announcing the 2025 Shionogi Inc. HBA Rising Star or Luminary on March 27. Monika Schneider, Ph.D., Seun M., Wenjing Zhao, Ph.D., Cristine Caterina (Buggeln), Jackie Balassone, Sharmila Bandekar, Lindsay Macrino, Risa Sho, Christine M. S., Desiree Holzlein

"I am often asked to describe the experience of raising a child with a disability... when you're going to have a baby, it's like planning a fabulous vacation trip – to Italy.... the flight attendant comes in and says, 'Welcome to Holland.'"-Emily Perl Kingsley ? Last night Shionogi and Healthcare Businesswomen’s Association (HBA) Northern New Jersey Chapter (HBA NY Tri-State region) convened leaders from across the pharma community for a learning and networking event focused on rare disease. ? We were honored to hear from Michelle Fruhschien, mom to a daughter with Jordan’s syndrome and creator of Mama Bear for Rare, who shared her story and the memorable Welcome to Holland poem. ? A panel of rare disease leaders including Helen Chang, Melissa Moser and Annie Curti spoke about being rare disease champions both within the industry and their personal lives. A big thank you to Alex Schepart, PharmD, MBA, for moderating the panel discussion and providing insights from his professional journey in rare disease. ? Many thanks to Marisa Dolled-Filhart, Vice President HBA Northern New Jersey Chapter, for your leadership and ongoing support with this event. We’re grateful for the opportunity to convene this important discussion and to hear from so many attendees whose lives have been touched by rare diseases. ? Thank you HBA for inspiring lifelong learning among members and the broader community. Find out about HBA membership here https://lnkd.in/ekGURdTi. ? #RareDisease #RareDiseaseMonth #JordansSyndrome

At Shionogi, our Town Hall meetings are a time to reconnect, learn about the important work our colleagues are doing, and look to the future together. While these gatherings are always engaging, our February meeting was particularly special. In honor of #RareDiseaseMonth, we focused on rare disease caregiver experiences and heard from Carole Bakhos, mom to a daughter with Jordan’s syndrome and Executive Director of?Jordan's Guardian Angels and Cindi Rogers, mother to two adult sons with Fragile X syndrome and a long-time advocate for National Fragile X Foundation.? Listening to their emotional and powerful stories gave us a deeper understanding of what it’s like to live with these conditions, and even more motivation to help bring options?to these communities.? Learn about our work in rare disease here: https://lnkd.in/etSxBJ6Z #RareDisease #RareDiseaseMonth #FragileXSyndrome #JordansSyndrome

On February 25th, our team joined families, caregivers, self-advocates, clinicians and researchers for the National Fragile X Foundation’s NFXF Advocacy Day on Capitol Hill. It was an inspiring day filled with powerful stories and unified voices, and we are proud to stand with families and advocates to raise awareness of this condition in advance of Rare Disease Day 2025. Learn about NFXF’s mission and work on behalf of the Fragile X community here: https://fragilex.org/