GSK-3844766A

GSK's Linerixibat Shows Significant Improvement in Cholestatic Pruritus for Primary Biliary Cholangitis Patients

14 days ago

• GSK's phase III GLISTEN trial demonstrates linerixibat significantly improves cholestatic pruritus (relentless itch) in patients with primary biliary cholangitis, addressing a major quality of life concern. • The late-breaking results were presented at the European Association for the Study of the Liver (EASL) Congress 2025, highlighting the potential for a new treatment option for this challenging symptom. • Primary biliary cholangitis is a chronic autoimmune liver disease that primarily affects women, with pruritus being one of the most debilitating symptoms impacting daily functioning and quality of life.

NanoViricides' Broad-Spectrum Antiviral NV-387 Advances to Phase II Trials for MPox Treatment

14 days ago

• NanoViricides has received approval from the Democratic Republic of Congo's National Ethics Committee to proceed with Phase II clinical trials of NV-387 for MPox treatment, addressing a significant unmet need as no effective treatment currently exists. • NV-387 employs a revolutionary host-mimetic mechanism that "looks like a cell" to viruses, potentially making it effective against 90-95% of human pathogenic viruses while being highly resistant to viral escape mutations. • The drug has demonstrated superior efficacy in animal models against multiple viruses including influenza, RSV, coronavirus, and orthopoxviruses, outperforming existing treatments like Tamiflu, remdesivir, and matching tecovirimat against MPox-like infections.

FDA Approves Blujepa, First New Class of Oral Antibiotic for UTIs in Nearly 30 Years

2 months ago

• GSK's Blujepa (gepotidacin) has received FDA approval for treating uncomplicated urinary tract infections, marking the first new class of oral antibiotics for UTIs in nearly three decades. • The novel triazaacenaphthylene antibiotic demonstrated non-inferiority or superiority to nitrofurantoin in clinical trials, offering a new treatment option amid rising antibiotic resistance concerns. • Blujepa works through a unique dual-enzyme inhibition mechanism that may reduce the potential for resistance development, with commercial availability expected in the second half of 2025.

Clover Advances RSV Vaccine Program with FDA Clearance for Revaccination Trial

2 months ago

• Clover Biopharmaceuticals has received U.S. FDA IND clearance and initiated a Phase I revaccination trial for SCB-1019, its non-adjuvanted RSV vaccine candidate utilizing the Trimer-Tag platform. • The ongoing trial will enroll up to 160 older adults previously vaccinated with GSK's AREXVY, comparing SCB-1019's effectiveness as a heterologous booster against homologous revaccination with AREXVY. • Earlier Phase I results showed SCB-1019 demonstrated potential best-in-class combined immunogenicity and tolerability compared to GSK's adjuvanted vaccine, with plans to evaluate it in combination vaccines targeting multiple respiratory viruses.

Moderna and Pfizer/BioNTech Locked in Escalating mRNA Patent Battle with Billions at Stake

2 months ago

• Moderna has filed patent infringement lawsuits against Pfizer/BioNTech in multiple countries, claiming their Comirnaty vaccine infringes on mRNA technology patents that Moderna pioneered and invested billions in developing. • The legal battle has expanded globally with Moderna scoring a recent victory in Germany, while simultaneously suffering defeats at the USPTO's Patent Trial and Appeal Board where some of its patents were found unpatentable. • With combined COVID-19 vaccine sales exceeding $100 billion, the financial stakes are enormous, as evidenced by significant settlements already reached with NIH—$400 million from Moderna and $791.5 million from BioNTech.

GSK Raises Five-Year Revenue Target to £40bn Following Strong Specialty Medicines Growth

4 months ago

• GSK reported a 3% increase in 2024 sales to £31.38bn, driven by impressive 19% growth in specialty medicines, with notable performance in HIV treatments and oncology drugs. • Despite overall growth, vaccine sales declined 4% in 2024, with further decreases projected for 2025, while core earnings per share rose 3% to 159.3p, falling short of analyst expectations. • The company has upgraded its five-year sales outlook to £40bn from £38bn, supported by a robust late-stage pipeline of 19 specialty medicines and vaccines in Phase III or registration stages.

GSK's Portfolio Resilience: Cancer and HIV Gains Offset RSV Vaccine Decline

4 months ago

• GSK experienced a significant 51% decline in Arexvy RSV vaccine sales to £590 million in 2024, following restricted US recommendations limiting use to adults 75 and older. • Strong performance in oncology with 72% sales growth to £408 million, driven by Jemperli and Ojjaara, while HIV portfolio showed double-digit growth through Cabenuva, Apretude, and Dovato. • Despite vaccine challenges, GSK upgraded its long-term sales forecast to £40 billion by 2031, supported by pipeline progress and planned launches in respiratory, oncology, and infectious diseases.

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.

Metsera's MET-097i Demonstrates Significant Weight Loss in Phase 2a Trial, Supporting Monthly Dosing Potential

5 months ago

• Metsera's MET-097i, an ultra-long acting GLP-1 receptor agonist, showed substantial placebo-adjusted weight loss of up to 11.3% after 12 weeks in a Phase 2a trial. • The study indicated a dose-dependent weight reduction with individual responses reaching ~20% in the 1.2mg dose cohort, and no weight loss plateau was observed. • MET-097i demonstrated a favorable tolerability profile, with mostly mild and transient gastrointestinal adverse events, particularly in the dose-escalated cohort. • Data support the feasibility of monthly dosing, with a four-fold increase in drug exposure over 12 weeks and well-tolerated step-up doses, paving the way for further studies.

RSV Vaccines Now Include Guillain-Barré Syndrome Warning

5 months ago

The FDA has announced that GSK and Pfizer's respiratory syncytial virus (RSV) vaccines will now carry warnings about the potential increased risk of Guillain-Barré syndrome (GBS), a rare neurological disorder, following vaccination. This decision comes after postmarketing trials suggested a heightened risk within 42 days post-vaccination, though a direct causal relationship has not been established.

FDA Approves Abrysvo for RSV Prevention in Adults Aged 18-59 at Increased Risk

5 months ago

• The FDA has approved Abrysvo, Pfizer's RSV vaccine, for adults aged 18-59 at increased risk of RSV-associated lower respiratory tract disease. • Abrysvo is the first RSV vaccine approved for adults younger than 50, addressing a crucial need for at-risk individuals in this age group. • Data from the pivotal Phase 3 MONET clinical trial supported the approval, highlighting the vaccine's efficacy in preventing RSV-related illness. • This approval marks a significant advancement in RSV prevention for younger adults with specific risk factors.

FDA Approves Moderna's mResvia RSV Vaccine for Older Adults

5 months ago

• The FDA has approved Moderna's mResvia (mRNA-1345), an mRNA vaccine, for the prevention of lower respiratory tract disease caused by RSV in adults aged 60 and over. • mResvia demonstrated 78.7% efficacy against RSV with two or more symptoms at 3.7 months, decreasing to 62.5% at 8.6 months follow-up in clinical trials. • The CDC's ACIP recommended mResvia for adults 75 and older and those aged 60-74 at increased risk of severe RSV, with ongoing trials evaluating other age groups. • mResvia enters a competitive market with GSK's Arexvy and Pfizer's Abrysvo, potentially differentiating itself through convenient administration and a lack of reported Guillain-Barré syndrome cases.

RSV Vaccines Show Weaker Immune Response in Immunocompromised Older Adults

5 months ago

• A recent study reveals that older, immunocompromised adults exhibit a weaker antibody response to RSV vaccines compared to healthy individuals. • The research indicates that approximately 40% of immunocompromised participants did not achieve seroconversion or meet neutralization thresholds post-RSV vaccination. • An adjuvanted vaccine (Arexvy) showed a tendency to induce higher levels of RSV-neutralizing antibodies compared to a non-adjuvanted vaccine (Abrysvo) in this population. • Further research is needed to optimize RSV vaccine strategies, including timing and selection, for immunocompromised individuals to enhance protection.

RSV Vaccine Safety Profile Monitored Across Age Groups and Populations

5 months ago

• Post-licensure data suggests a slightly increased risk of Guillain-Barré syndrome (GBS) following GSK and Pfizer RSV vaccination in adults 60 and older, with ongoing monitoring by the CDC and FDA. • Clinical trials of Pfizer's RSV vaccine (Abrysvo) in pregnant individuals showed a non-statistically significant increase in preterm births, leading to its approval for use between 32 and 36 weeks of gestation. • A Phase 3 trial indicates that the RSVpreF vaccine is safe and effective for adults aged 18-59 at high risk for severe RSV, with immunogenicity bridged to older adults from the RENOIR trial. • Nirsevimab passive immunization for infants and young children has shown no significant safety concerns in clinical trials, although post-licensure reports indicate rare cases of serious hypersensitivity reactions.

FDA Adds Guillain-Barré Syndrome Warning to Pfizer and GSK RSV Vaccines

5 months ago

• The FDA now requires updated safety labels for Pfizer's Abrysvo and GSK's Arexvy RSV vaccines to include a warning about Guillain-Barré Syndrome (GBS). • Postmarketing studies suggest an increased risk of GBS within 42 days following vaccination with either Abrysvo or Arexvy, particularly in adults 65 and older. • The FDA emphasizes that while the data indicates a potential increased risk of GBS, a causal relationship between the vaccines and GBS has not been established. • Despite the GBS warning, the FDA maintains that the benefits of Abrysvo and Arexvy in preventing RSV-related lower respiratory tract disease continue to outweigh the risks.

Real-World Study Confirms High Effectiveness of RSV Vaccines in Older Adults

5 months ago

• A real-world study among older US veterans showed RSV vaccines are highly effective against infection, ED/UC visits, and hospitalization. • The study found vaccine effectiveness of 78% against RSV infection, 79% against ED/UC visits, and 80% against hospital admissions. • Vaccine effectiveness against RSV infection was 72.3% in veterans aged 80 years and older and 71.6% in those with weakened immune systems. • The findings support current recommendations for RSV vaccination in adults aged 60 years and older, with updated CDC guidance for the 2024-2025 season.

FDA Accepts Merck's Clesrovimab BLA for RSV Prevention in Infants

5 months ago

• The FDA has accepted Merck's Biologics License Application (BLA) for clesrovimab, a long-acting monoclonal antibody, with a decision expected by June 10, 2025. • Clesrovimab aims to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season with a single-dose administration. • Clinical trial data from the CLEVER and SMART studies support the BLA, demonstrating a significant reduction in RSV-associated infections and hospitalizations. • If approved, Merck anticipates clesrovimab will be available for order by July 2025, targeting the 2025-2026 RSV season, offering a potential competitive edge.

FDA Grants Breakthrough Therapy Designation to GSK's Jemperli for Advanced Rectal Cancer

5 months ago

• The FDA granted Breakthrough Therapy Designation to GSK's Jemperli (dostarlimab) for locally advanced dMMR/MSI-H rectal cancer. • The designation was based on a Phase II trial showing a 100% clinical complete response rate in all 42 patients treated with dostarlimab. • Jemperli targets the PD-1 receptor and aims to improve the immune system's ability to eradicate cancer cells without traditional treatments. • The AZUR-1 trial is ongoing to confirm these findings, potentially changing the treatment paradigm for this subset of rectal cancer patients.

GSK's GSK'227 Receives FDA Breakthrough Therapy Designation for Relapsed Osteosarcoma

5 months ago

• The FDA granted Breakthrough Therapy Designation to GSK'227 for relapsed or refractory osteosarcoma after two prior lines of therapy. • The designation aims to expedite the development of GSK'227, a B7-H3-targeted antibody-drug conjugate, for this rare bone cancer. • The FDA's decision was based on promising data from the ARTEMIS-002 trial, which evaluated GSK'227 in osteosarcoma patients. • GSK'227 represents a potential new treatment option for osteosarcoma patients with limited alternatives after chemotherapy failure.

FDA Panel Urges Caution and More Data on RSV Vaccine Safety in Infants

5 months ago

• An FDA advisory panel called for more safety data on RSV vaccines for infants, highlighting concerns after a partial pause in clinical trials. • The pause was triggered by cases of severe RSV in infants receiving Moderna's experimental vaccines, raising questions about vaccine-associated enhanced respiratory disease (VAERD). • The panel emphasized the need for a better understanding of immune responses in different age groups and continued monitoring of trial participants. • Despite concerns, advisors spoke positively about Sanofi's Beyfortus and Pfizer's maternal RSV vaccine, and did not call for halting all infant RSV vaccine studies.

Drug Development Updates