SHIONOGI & CO., LTD.

Shionogi and Cilcare Partner in €400M Deal to Develop Novel Hearing Loss Treatments

13 days ago

• Shionogi has entered into a joint research agreement with Cilcare to develop innovative treatments for hearing loss, a condition affecting 5% of the global population with no effective treatments currently available. • The collaboration combines Shionogi's drug discovery expertise with Cilcare's specialized knowledge in hearing loss and advanced non-clinical evaluation technology to accelerate development of novel mechanism treatments. • The partnership builds on a previous €400 million option agreement for Cilcare's hearing loss candidates CIL001 and CIL003, with Phase 2a studies for CIL001 planned to begin in fiscal year 2025.

Single-Dose Baloxavir Significantly Reduces Household Influenza Transmission in Global Phase III Trial

a month ago

• The landmark CENTERSTONE trial demonstrates that a single oral dose of baloxavir marboxil (Xofluza) reduces influenza transmission within households by 32%, marking the first evidence that an antiviral can curb respiratory virus spread. • Conducted across 15 countries with over 4,000 participants between 2019-2024, the study showed baloxavir led to faster viral load reduction compared to placebo, with results now published in The New England Journal of Medicine. • While drug-resistant viruses emerged in 7.2% of treated patients, they were not detected in household contacts, suggesting limited transmission risk of resistant strains.

Ensitrelvir Shows 67% Reduction in COVID-19 Risk as First Effective Post-Exposure Prophylaxis in Phase 3 Trial

2 months ago

• Shionogi's SCORPIO-PEP Phase 3 trial demonstrated ensitrelvir reduces COVID-19 risk by 67% in exposed household contacts, making it the first oral antiviral to successfully prevent COVID-19 after exposure. • The study included over 2,000 participants who received either ensitrelvir or placebo within three days of household exposure, with only 2.9% of treated individuals developing COVID-19 compared to 9.0% on placebo. • Ensitrelvir received FDA Fast Track designation for post-exposure prophylaxis in 2025 and could fill a critical unmet need, particularly for immunocompromised individuals and in healthcare settings.

Shionogi and Osaka Metropolitan University Form Strategic Alliance to Combat Infectious Diseases

3 months ago

• Shionogi and Osaka Metropolitan University have established a comprehensive collaboration agreement focused on infectious disease research, diagnostics development, and public health system strengthening. • The partnership will leverage Osaka Metropolitan University's broad academic expertise through OIRCID and Shionogi's pharmaceutical innovation capabilities to create an 'Osaka Model' for pandemic preparedness. • The collaboration encompasses education, research, public health system enhancement, and policy development, with specific focus on preventing and responding to future infectious disease crises.

Shionogi's Antibiotic Fetroja Receives Marketing Approval in South Korea for Drug-Resistant Infections

3 months ago

• JEIL Pharmaceutical has secured regulatory approval in South Korea for Fetroja (cefiderocol), a novel siderophore cephalosporin antibiotic targeting carbapenem-resistant gram-negative bacterial infections. • The approval is based on three global clinical trials, including studies in complicated urinary tract infections, carbapenem-resistant infections, and nosocomial pneumonia. • This development addresses the growing threat of antimicrobial resistance (AMR), which is projected to cause over 10 million deaths annually by 2050 without proper intervention.

Shionogi Secures Japan's First ADHD Digital Therapeutic Approval with ENDEAVORRIDE

3 months ago

• Shionogi has received Japanese regulatory approval for ENDEAVORRIDE, marking the country's first digital therapeutic application specifically designed for pediatric ADHD patients. • The app, developed by Akili Inc., utilizes proprietary SSME technology to target the prefrontal cortex, aiming to improve attention, hyperactivity, and impulsivity symptoms in children. • Following successful Phase 3 trials in Japan, ENDEAVORRIDE will be available as an adjunctive therapy, expanding treatment options beyond traditional pharmacological and psychosocial interventions.

NeuroTherapia and Sinaptica Advance Alzheimer's Therapies into Phase 2 Trials

4 months ago

• NeuroTherapia's NTRX-07, an oral neuroinflammatory inhibitor, receives EMA approval for a Phase 2 trial in Alzheimer's disease, aiming to improve neuronal function. • Sinaptica Therapeutics initiates a Phase 2 trial for its second-generation SinaptiStim® system, combining rTMS and transcranial alternating current stimulation for early Alzheimer's. • Sinaptica's dual stimulation technology shows potential for enhanced efficacy and reduced treatment time, building on positive Phase 1 data in healthy volunteers.

Shionogi's Oral Antiviral S-337395 Shows Promise in Phase 2 RSV Human Challenge Trial

4 months ago

• Shionogi's investigational oral antiviral S-337395 significantly reduced viral load in a Phase 2 human challenge trial for Respiratory Syncytial Virus (RSV). • The highest dose group of S-337395 demonstrated an 88.94% reduction in viral load compared to the placebo group (P<0.0001), along with improved clinical symptom scores. • S-337395 was generally safe and well-tolerated, with no serious adverse events reported during the randomized, double-blind, placebo-controlled study. • The drug, which has received FDA Fast Track designation, inhibits the RSV L protein, essential for viral replication, offering a potential new treatment approach.

Taiwan Accepts New Drug Application for COVID-19 Treatment Ensitrelvir

4 months ago

Shionogi & Co., Ltd. announced the Taiwan Food and Drug Administration's acceptance of a new drug application for ensitrelvir fumaric acid, an oral antiviral for COVID-19. This marks a significant step in expanding treatment options against the virus, especially considering the estimated 1.7 million COVID-19 patients in Taiwan annually.

Shionogi Advances Development of Long-Acting COVID-19 Antiviral with BARDA Support

4 months ago

Shionogi & Co., Ltd. has been awarded a $375 million project agreement by BARDA to develop S-892216, a long-acting injectable antiviral for COVID-19 pre-exposure prophylaxis. This initiative aims to address the unmet need for effective pre-exposure prophylaxis therapeutics, with phase 1 studies expected to begin in 2025. S-892216, a second-generation 3CL protease inhibitor, has shown strong antiviral effects in pre-clinical trials and is being developed in both injectable and oral forms.

Maze Therapeutics Initiates Phase 2 Trial of MZE829 for APOL1 Kidney Disease

4 months ago

• Maze Therapeutics has dosed the first patient in its Phase 2 HORIZON study, evaluating MZE829 for APOL1 kidney disease (AKD). • The HORIZON trial is an open-label, basket design study including AKD patients with varying degrees of proteinuria and diabetic AKD. • The primary endpoint is a 30% or greater reduction in proteinuria, measured by urinary albumin-to-creatinine ratio (uACR) at week 12. • Interim proof-of-concept data from the HORIZON study is expected in the first quarter of 2026, according to Maze Therapeutics.

Esophageal Cancer Treatment Landscape Evolves with Novel Therapies and Approvals

5 months ago

• The esophageal cancer market is expected to grow significantly, driven by increasing prevalence and the introduction of novel therapies. • In 2023, approximately 77,000 new cases of esophageal cancer were reported across seven major markets, with Japan having the highest number. • Recent FDA approval of TEVIMBRA (tislelizumab) as a monotherapy marks a significant advancement in treating unresectable or metastatic ESCC. • Emerging therapies like zanidatamab and bemarituzumab are expected to revolutionize the esophageal cancer market dynamics during the forecast period.

Cilcare Secures €40 Million to Advance Cochlear Synaptopathy Treatment

6 months ago

• Cilcare has secured €40 million in Series A funding to support clinical trials for CIL001, a treatment for cochlear synaptopathy, also known as 'hidden hearing loss'. • Two Phase 2a clinical trials are planned for 2025, focusing on patients with Type 2 diabetes and those with neurodegenerative disorders. • Cilcare is leveraging AI and machine learning to identify auditory biomarkers, enhancing the precision and success rate of its therapeutic developments.

Thrombocytopenia Treatment Market Shows Promising Growth with Novel Therapies and Clinical Trials

6 months ago

• The thrombocytopenia market is experiencing significant growth, driven by the introduction of novel therapies and ongoing clinical trials. • Key players like Sanofi, Takeda, and Amgen are actively involved in developing and marketing treatments for various types of thrombocytopenia. • Emerging therapies such as Rilzabrutinib and Nipocalimab show promise in addressing unmet needs in immune and alloimmune thrombocytopenia. • Clinical trials are exploring new treatments for chemotherapy-induced thrombocytopenia and myelofibrosis-related thrombocytopenia.

Ensitrelvir Shows Promise as Post-Exposure Prophylaxis for COVID-19 in Phase 3 Trial

7 months ago

• Shionogi's ensitrelvir significantly reduced symptomatic SARS-CoV-2 infection in individuals exposed to household contacts with COVID-19, meeting the primary endpoint in a Phase 3 trial. • The global, double-blind, randomized, placebo-controlled SCORPIO-PEP study evaluated once-daily ensitrelvir for post-exposure prophylaxis. • Ensitrelvir was well-tolerated among study participants, with no new safety concerns identified during the trial. • These findings suggest ensitrelvir could be a valuable tool in preventing symptomatic COVID-19 following exposure.

Ensitrelvir Shows Promise as Post-Exposure Prophylaxis for COVID-19 in Phase 3 Trial

7 months ago

• Shionogi's ensitrelvir significantly reduced symptomatic SARS-CoV-2 infection in individuals exposed to household contacts with COVID-19, meeting the primary endpoint in a Phase 3 trial. • The SCORPIO-PEP study involved approximately 2,400 participants and demonstrated that once-daily ensitrelvir was well-tolerated with no new safety concerns identified. • This investigational oral antiviral, which inhibits the 3CL protease, could offer a convenient preventive approach, especially where no oral antiviral medications are approved for post-exposure prophylactic use. • Ensitrelvir has already received regulatory approvals for COVID-19 treatment in Japan and Singapore, but remains investigational in other regions.

FDA Grants Fast Track Designation to Shionogi's Novel Anti-RSV Drug Candidate S-337395

7 months ago

• The FDA has granted Fast Track designation to Shionogi's S-337395, a novel oral anti-RSV drug candidate, to expedite its development and review process. • S-337395 targets a protein essential for RSV replication, demonstrating a dose-dependent reduction of RSV in the lungs in preclinical trials. • A Phase 2 trial is currently underway to assess the efficacy and safety of S-337395 in patients with RSV infection. • Fast Track designation allows for more frequent FDA consultations and staged submission of application materials, potentially accelerating its availability.

Shionogi Submits Zuranolone NDA in Japan for Major Depressive Disorder

8 months ago

• Shionogi has submitted a New Drug Application (NDA) in Japan for zuranolone, targeting the treatment of major depressive disorder (MDD). • The NDA is supported by Phase 3 trial data in Japan, which demonstrated statistically significant improvements in MDD symptoms. • Zuranolone, a neuroactive steroid GABA-A receptor modulator, has shown rapid efficacy, potentially addressing the need for faster-acting treatments. • Zuranolone is already approved in the U.S. for postpartum depression and could offer a novel treatment option for MDD in Japan.

Xofluza Significantly Reduces Influenza Transmission in Phase III Trial

8 months ago

• Roche's Xofluza (baloxavir marboxil) significantly reduced influenza transmission within households in a Phase III trial, marking a potential advance in flu control. • The CENTERSTONE study met its primary endpoint, showing a single oral dose of Xofluza reduced the likelihood of household members contracting the virus. • The antiviral treatment was well-tolerated, with no new safety signals, suggesting a favorable risk-benefit profile for influenza prevention. • These results could improve health outcomes at both individual and community levels, especially for influenza pandemic preparedness.

Apnimed's AD109 Phase 3 Trial for Obstructive Sleep Apnea Completes Enrollment

8 months ago

• Apnimed has completed enrollment for its Phase 3 SynAIRgy study evaluating AD109, a potential oral treatment for obstructive sleep apnea (OSA). • The SynAIRgy study assesses the efficacy and safety of AD109 compared to placebo over six months in adults with mild, moderate, and severe OSA. • AD109 targets the neuromuscular dysfunction underlying OSA, potentially offering a novel approach to improve oxygenation during sleep. • Topline Phase 3 data from both the SynAIRgy and LunAIRo studies of AD109 are expected in mid-2025.