University of Leicester

Rejuvenate Biomed Initiates Phase II Trial of RJx-01 for COPD-Related Muscle Weakness

3 days ago

• Rejuvenate Biomed has dosed the first subject in a randomized Phase II trial evaluating RJx-01 for muscle weakness and sarcopenia in COPD patients, addressing a condition with no currently approved treatments. • The double-blind, placebo-controlled study will enroll 130 older adults hospitalized with severe acute COPD exacerbation, measuring the drug's impact on muscle strength, physical function, and fatiguability. • RJx-01 previously demonstrated improvements in muscle strength and function in Phase I trials, targeting multiple cellular pathways related to muscle quality decline including mitochondrial health.

PARP Inhibitor Niraparib Shows Breakthrough Results in Mesothelioma Treatment

22 days ago

• UK researchers have demonstrated for the first time that PARP inhibitor niraparib can slow the progression of mesothelioma, reducing the risk of disease progression or death by 27% in patients who exhausted traditional treatments. • The NERO trial, conducted across 11 UK hospitals with 88 patients, showed the drug delayed cancer worsening by an average of 1.5 months compared to standard care, with some patients experiencing significantly longer disease control. • This breakthrough offers new hope for mesothelioma patients, an aggressive asbestos-linked cancer with only 5% five-year survival rate, and opens pathways for further research into tailored PARP inhibitor treatments.

Sarcopenia Pipeline Shows Robust Growth with 18+ Pharma Companies Developing Novel Therapies

a month ago

• The sarcopenia market remains largely untapped with no approved drug therapies in major markets, despite significant unmet medical needs in an aging global population. • DelveInsight reports 18+ pharmaceutical companies actively developing 20+ pipeline drugs for sarcopenia, with promising candidates including Biophytis' BIO101, TNF Pharmaceuticals' MYMD-1, and Epirium Bio's MF-300. • Recent regulatory milestones include Fast Track Designation for Lipocine's LPCN1148 for sarcopenia in patients with decompensated cirrhosis, signaling increased recognition of sarcopenia as a distinct clinical condition.

Genetic Variants Influence Success of Smoking Cessation Drug Varenicline, Landmark Study Finds

3 months ago

• University of Leicester researchers conducted the first genome-wide study revealing genetic variations affect varenicline's effectiveness in smoking cessation, offering new insights into personalized treatment approaches. • The comprehensive analysis utilizing UK Biobank and international health records identified specific DNA variants linked to successful smoking cessation with varenicline treatment. • The groundbreaking findings illuminate the biological mechanisms underlying varenicline-aided smoking cessation, though researchers emphasize the need for larger confirmatory studies.

Rejuvenate Biomed Partners with NIHR Leicester BRC for Phase 2 Trial of Novel COPD-Related Sarcopenia Treatment

7 months ago

• Rejuvenate Biomed, University of Leicester, NIHR Leicester BRC, and Wellcome Leap have partnered to conduct a Phase 2 clinical trial evaluating RJx-01 for COPD-related sarcopenia, with patient enrollment expected to begin in the first half of 2025. • The double-blind placebo-controlled trial will assess RJx-01's safety and efficacy in 130 older individuals hospitalized with severe acute COPD exacerbations, focusing on maintaining muscle integrity and improving physical function. • RJx-01 previously demonstrated promising results in a Phase 1b trial, showing meaningful improvements in muscle strength, function, and fatigue resistance in people with disuse-induced muscle weakness.

Atacicept Shows Promise in Slowing Kidney Function Decline in IgA Nephropathy

7 months ago

• Data from the ORIGIN trial's open-label extension indicate that atacicept may slow kidney function decline in IgA nephropathy patients to a rate comparable to normal aging. • Atacicept, a dual BAFF/APRIL inhibitor, demonstrated sustained reductions in galactose-deficient IgA1, hematuria, and urine protein to creatinine ratio (UPCR) over 96 weeks. • The annualized slope of eGFR was -0.6 mL/min/1.73m2 per year, suggesting a significant slowing of kidney function loss compared to typical progression. • A phase 3 trial of atacicept is underway, with topline results expected in Q2 2025, potentially marking a major advancement in IgA nephropathy management.

Biogen's Felzartamab Shows Promise in Phase 2 IgAN Trial

7 months ago

• Biogen's felzartamab demonstrated a 50% reduction in proteinuria in IgA nephropathy (IgAN) patients through 24 months in a Phase 2 trial. • The IGNAZ study showed stable kidney function and sustained treatment effects more than 18 months after the last dose of felzartamab. • Felzartamab selectively reduced IgA antibody levels while maintaining IgG and IgM levels, suggesting preservation of immune function. • Biogen is planning Phase 3 development for felzartamab based on the encouraging results and safety profile observed in the study.

Biogen's Felzartamab Shows Sustained Efficacy in IgA Nephropathy Phase 2 Trial

7 months ago

• Biogen's felzartamab demonstrated substantial proteinuria reduction and kidney function stabilization in IgA nephropathy patients in a Phase 2 trial. • The treatment effect of felzartamab was sustained for over 18 months after the last dose, suggesting potential for cyclical administration. • Felzartamab selectively reduced IgA antibody levels while allowing IgG and IgM levels to recover, potentially preserving essential immune functions. • The Phase 2 IGNAZ study results support the ongoing Phase 3 development of felzartamab as a potential treatment for IgA nephropathy.

Atacicept Shows Sustained eGFR Stabilization in IgAN Patients Over 96 Weeks

7 months ago

• Vera Therapeutics' atacicept demonstrated stabilization of kidney function in IgAN patients over 96 weeks in the ORIGIN Phase 2b trial. • The study showed significant reductions in Gd-IgA1, hematuria, and proteinuria, suggesting disease modification. • Topline results from the Phase 3 ORIGIN 3 trial are expected in Q2 2025, with a planned BLA submission to the FDA later that year.

Atacicept Shows Sustained Efficacy in IgA Nephropathy Treatment

7 months ago

• Atacicept demonstrates potential as a disease-modifying agent for IgA nephropathy, according to 96-week data from the ORIGIN trial's open-label extension. • The study showed significant reductions in Gd-IgA1 levels (66%), hematuria (75%), and UPCR (52%) among patients treated with atacicept. • Patients treated with atacicept experienced a notably slow decline in kidney function, with an eGFR annualized slope of -0.6 mL/min/1.73m2 per year. • Atacicept, administered as a weekly self-injection, targets disease-causing cytokines, offering a practical, long-term treatment option for patients.

Vera Therapeutics to Discuss Atacicept's Expanded R&D for Immunological Diseases

8 months ago

• Vera Therapeutics will host an R&D Day on October 2, 2024, to discuss expanding atacicept's development for immunological diseases. • The discussion will include experts like Jonathan Barratt, Richard Lafayette, and Brad Rovin, alongside Vera's management team. • The event precedes the anticipated 96-week data release from the Phase 2b ORIGIN study of atacicept in IgAN in Q4 2024. • Atacicept has received FDA Breakthrough Therapy Designation for IgAN, showing potential for significant improvement over existing therapies.

Targeting the Endothelin A Receptor in IgA Nephropathy: A New Therapeutic Approach

2 years ago

Recent advancements in the treatment of IgA Nephropathy (IgAN) focus on targeting the Endothelin-A receptor (ETAR) to mitigate renal deterioration. This approach is based on the understanding that ETAR activation contributes to various pathophysiological effects in the kidney, including vasoconstriction, inflammation, and fibrosis. Clinical trials have shown that ETAR blockade can reduce proteinuria and slow disease progression, offering a promising new avenue for IgAN treatment.

Savana Leverages AI to Transform EHR Data into Actionable Clinical Insights

4 years ago

• Savana's AI-powered platform analyzes unstructured electronic health record data across 14 countries in five languages, enabling unprecedented access to real-world clinical evidence. • The company's technology has demonstrated significant value during COVID-19 pandemic through the BigCOVIData study, revealing key insights about disease characteristics and predictive factors. • Using advanced Natural Language Processing and privacy-preserving techniques, Savana helps pharmaceutical companies and researchers unlock previously inaccessible clinical data while maintaining patient confidentiality.