Clinical Trial News

Sun Pharmaceutical Industries and Moebius Medical received FDA Fast Track designation for MM-II (Large Liposomes of DPPC and DMPC) to treat osteoarthritis knee pain, with Phase 3 clinical trials planned.

GSK's Nucala showed significant reduction in COPD flare-ups in a trial, potentially expanding its use beyond asthma treatment.

Lykos Therapeutics CEO Amy Emerson to step down after FDA rejection of MDMA therapy aid approval. Michael Mullette appointed interim CEO. Company plans to cut 75% of workforce and resubmit MDMA approval application.

Clinical trial in Colorado aims to treat Alzheimer's; electric vehicles impact firefighting; Native American skier Ross Anderson inducted into Colorado Snowsports Museum; Mount Blue Sky closes for repairs until 2026; 'Turn the Page with Colorado Matters' features Tim Winegard's 'The Horse.'

Rigel Pharmaceuticals announced the first patient enrolled in a Phase 1b/2 triplet therapy trial of REZLIDHIA (olutasidenib) combined with decitabine and venetoclax for mIDH1 AML, conducted by MD Anderson. The trial aims to determine safety, tolerability, and complete remission rates in newly diagnosed and relapsed/refractory patients.

Verastem, Inc. (VSTM) develops cancer treatments targeting the RAS/MAPK pathway, focusing on pancreatic, lung, colorectal, and low-grade serous ovarian cancers. Its leading therapy combines Avutometinib and Defactinib, with a rolling NDA submission expected to finalize by 2H2024 for recurrent LGSOC. VSTM also explores additional indications for metastatic pancreatic cancer and mKRAS G12C NSCLC. The company's tight cash runway makes it a high-risk, high-reward investment, but its current valuation and pathway to approval suggest a bullish outlook.

FDA grants orphan drug designation to certepetide for cholangiocarcinoma. Certepetide is being evaluated in phase 2 BOLSTER trial with SOC therapies. It enhances drug delivery and tumor microenvironment modulation. BOLSTER trial includes first- and second-line treatments with certepetide. Certepetide also has ODD for malignant glioma, osteosarcoma, and pancreatic cancer.

UltraDx Bio's UD-X™ Single-Molecule Analyzer received China's first clinical registration approval, revolutionizing early screening for Alzheimer's Disease. The analyzer, listed on the National Medical Products Administration website, detects trace protein biomarkers at the fg/ml scale, addressing precision detection needs in clinical diagnostics.

FDA approved seven new therapies in August, including a competitor to Dupixent for prurigo nodularis, Gilead’s PPARδ agonist, and targeted cancer therapies.

Pyrotinib plus metronomic vinorelbine showed safety and efficacy in HER2+ advanced breast cancer post-trastuzumab, with median PFS of 13.5 months and ORR of 38.9%. The study highlights the need for alternative therapies due to economic constraints on ADCs. Subgroup analysis revealed better PFS in patients with lung metastases and primary trastuzumab resistance. No new AEs were reported, and the regimen warrants further study.