Charité - Universitätsmedizin Berlin

Isofol Medical Advances Arfolitixorin Development with New Phase Ib/II Trial for Metastatic Colorectal Cancer

2 months ago

• Isofol Medical has received regulatory approval to initiate a Phase Ib/II clinical trial evaluating arfolitixorin in first-line treatment of metastatic colorectal cancer at Germany's prestigious Charité Universitätsmedizin Berlin. • The new study implements an optimized dosing regimen with higher doses administered earlier in the treatment cycle, designed to enhance arfolitixorin's synergistic effects with 5-FU chemotherapy. • The trial will replace leucovorin with arfolitixorin in standard treatment protocols and will be conducted in two stages: dose escalation assessment followed by efficacy comparison between selected dosages.

United Therapeutics' UKidney Xenotransplant Trial Receives FDA Clearance

4 months ago

• United Therapeutics received FDA clearance for its IND application to begin clinical trials for UKidney, a gene-edited pig kidney, marking a significant step in xenotransplantation. • The phase 1/2/3 trial will enroll ESRD patients, including those ineligible for traditional transplants and those unlikely to receive a kidney within five years. • UKidney features 10 gene edits to enhance compatibility and reduce rejection, offering a potential alternative to dialysis for patients with limited options. • The trial's primary endpoints include patient and UKidney survival rates, changes in glomerular filtration rate, and quality of life improvements over a 24-week period.

PEARLDIVER: Europe-Wide Platform Trial Aims to Accelerate Depression Treatment Development

4 months ago

• The PEARLDIVER project, a Europe-wide platform study, will evaluate multiple depression treatments simultaneously using a shared infrastructure. • Initially focusing on repurposed drugs, the trial aims to expedite the identification of effective therapies for individual patients. • With over €13 million in funding from Wellcome, the study involves six European university medical centers and incorporates patient input in its design. • Enrollment is expected to begin in 2026, with the first year dedicated to building the platform and assessing the safety and efficacy of initial medications.

Bimekizumab Shows Sustained Efficacy in Psoriatic Arthritis at 2 Years

6 months ago

• Bimekizumab demonstrates durable efficacy in psoriatic arthritis (PsA) across diverse patient populations, including those new to biologic treatments and those with TNF inhibitor resistance. • In clinical trials, over 70% of patients achieving ACR50 response at week 16 maintained it at 2 years, with significant skin clearance rates observed in both bDMARD-naïve and TNFi-IR groups. • Patients on bimekizumab reported sustained reductions in pain and fatigue, with almost half experiencing a ≥50% decrease in pain and improvements in fatigue scores over the 2-year period. • Long-term safety analyses confirm a consistent safety profile for bimekizumab, marking it as a valuable therapeutic option for PsA and axial spondyloarthritis (axSpA) patients.

Denosumab and Tocilizumab Biosimilars Show Promise in Phase 3 Trials

6 months ago

• CT-P41, a denosumab biosimilar, demonstrated comparable efficacy and safety to reference denosumab in postmenopausal women with osteoporosis over 78 weeks. • Switching from reference tocilizumab to CT-P47, a tocilizumab biosimilar, showed sustained efficacy, safety, and immunogenicity in rheumatoid arthritis patients over one year. • Financial incentives in Japan correlated with increased biosimilar prescriptions for oncology, suggesting a pathway to broader biosimilar adoption. • A study found that switching between rituximab biosimilars does not increase the risk of adverse events in patients with oncohematological diseases.

Bimzelx Shows Sustained Efficacy and Safety in Psoriatic Arthritis and Axial Spondyloarthritis

6 months ago

• Two-year data from Phase III trials confirm the long-term efficacy and safety of Bimzelx in treating active psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis. • Bimzelx maintained high levels of clinical response, including skin clearance and improved joint pain, with over 70% of week 16 responders sustaining a 50% improvement in ACR criteria over two years. • In patients with nr-axSpA and AS, Bimzelx maintained high efficacy across all domains, with over 80% achieving ASAS40 at week 16 and maintaining the response for two years. • The safety profile of Bimzelx was consistent with prior findings, with no new safety signals reported in patients with active nr-axSpA, AS, and active PsA.

Germany Grapples with Integrating Psychedelic-Assisted Therapy Amid Regulatory Hurdles and Training Gaps

7 months ago

• Germany faces challenges in integrating psychedelic-assisted therapy (PAT) due to strict regulations and limited access to psychedelic substances. • Economic burdens of PTSD and depression in Germany highlight the urgent need for more effective interventions like PAT, potentially reducing healthcare costs. • The European Medicines Agency (EMA) is evaluating psychedelics, prompting Germany to prepare for innovative treatments through structured frameworks. • A proposed German training model, BuNT, aims to certify PAT practitioners, addressing the current mismatch between trained therapists and patient demand.

CHMP Recommends Approval of Lindis Biotech's Korjuny (catumaxomab) for Malignant Ascites

7 months ago

• The CHMP has recommended KORJUNY® (catumaxomab) for malignant ascites in adults with EpCAM-positive carcinomas who cannot receive further systemic anticancer therapy. • Clinical data from a Phase II/III trial demonstrated a statistically significant improvement in puncture-free survival for patients treated with KORJUNY®. • If approved by the European Commission, KORJUNY® will be the only drug available for cancer-directed treatment of malignant ascites in the EU. • Catumaxomab, the active ingredient in KORJUNY®, is also being investigated for other indications, including non-muscle invasive bladder cancer.

Study Finds No Increased Parkinson's Risk for Women with Migraines

9 months ago

• A new study of over 39,000 women found no link between migraines and an increased risk of developing Parkinson's disease, refuting earlier research. • The 22-year follow-up showed that women with migraines were no more likely to develop Parkinson's than those without migraines, regardless of migraine frequency or aura. • Researchers emphasize that further studies are needed to confirm these findings across diverse populations, including men and various ethnic groups. • The results offer reassurance to women who experience migraines, alleviating concerns about a potential elevated risk of Parkinson's disease later in life.