Clinical Trial News

FDA issued a Complete Response Letter for dasiglucagon in congenital hyperinsulinism due to third-party manufacturing issues, not drug safety. Zealand Pharma plans to resubmit NDA in 2024 after resolving deficiencies. Dasiglucagon aims to treat hypoglycemia in CHI patients, addressing a significant unmet medical need.

Arch Biopartners Inc. has received ethics committee approval in Turkey to proceed with a Phase II trial for its LSALT peptide, aimed at preventing and treating cardiac surgery-associated acute kidney injury (CS-AKI). The trial awaits final regulatory review by the Turkish Ministry of Health, with patient enrollment expected to begin in February.

MaaT Pharma, a leading microbiome therapeutics company, is making significant strides in oncology with its innovative treatments. The company's lead product, MaaT013, is currently in phase 3 trials for gastrointestinal acute graft-versus-host Disease (GI-aGvHD), showing promising results. Additionally, MaaT Pharma is exploring the potential of its second candidate, MaaT033, in enhancing overall survival for HSCT and cellular therapy recipients, marking a pivotal moment in microbiome-based cancer treatment.

GSK and Hansoh Pharma announced an exclusive license agreement for HS-20093, a B7-H3 targeted antibody-drug conjugate, showing promising clinical activity in lung cancer. GSK gains worldwide rights (excluding China) for development and commercialization, with Hansoh eligible for up to $1.525 billion in milestones and royalties. HS-20093 is in phase I/II trials in China, with GSK planning phase I trials outside China in 2024.

Psilocybin, a hallucinogenic substance from certain mushrooms, showed promise in reducing depression symptoms in a phase two trial, with 80% of participants showing sustained response and 50% achieving full remission. Despite being classified as a Schedule I drug with no accepted medical use, the study highlights its potential for psychological treatment, especially in cancer patients. The trial emphasized a group therapy approach, with participants reporting significant improvements and positive experiences. However, further research with larger groups and control arms is needed to fully understand its efficacy and implications.

Bridging therapy before axicabtagene ciloleucel (axi-cel) for relapsed/refractory large B-cell lymphoma (LBCL) did not improve efficacy or safety outcomes, per a CIBMTR analysis. Adjusted analyses showed no significant differences in outcomes between bridging and non-bridging therapy groups, despite initial disparities in response rates and survival metrics.

Spectral Medical Inc. updates on Tigris trial, a Phase 3 study for PMX in treating endotoxemia and septic shock, with 81 patients enrolled. Strong enrollment and screening activity continue, nearing the interim target of 90 patients. Preliminary mortality data exceeds expectations. Spectral also completed the EDEN study, providing valuable data on septic shock and endotoxin activity.

Eflornithine (Iwilfin) FDA-approved to reduce relapse risk in high-risk neuroblastoma patients post-therapy. Based on Study 3b and ANBL0032 trials, showing improved event-free and overall survival. Common adverse effects include otitis media, diarrhea, and cough.

Axicabtagene ciloleucel (axi-cel) improved overall and progression-free survival in elderly patients with relapsed/refractory large B-cell lymphoma, as per ZUMA-7 trial subgroup analysis. Axi-cel showed prolonged survival over standard care, suggesting age should not limit CAR T-cell therapy consideration. Adverse effects were noted but axi-cel was deemed a curative second-line option.

Phase I trial of AT101, a novel CAR T cell therapy targeting CD19 differently, shows 100% complete response at higher doses in relapsed/refractory B cell NHL patients, indicating potential for broader efficacy. Findings presented at ASH and published in Molecular Cancer.