Clinical Trial News

Maxim Group's Jason McCarthy maintains Buy rating on Unicycive Therapeutics (UNCY) due to the NDA submission for OLC, potential cost savings, and favorable study results. Despite price target reduction due to TDAPA uncertainties, OLC's approval could unlock significant revenue. UNCY's stock has dropped 76.86% over six months.

Emily Jarvie, a journalist with experience in political, business, and scientific reporting, joined Proactive in 2022. Proactive provides global investment news, operating in finance hubs worldwide, focusing on medium and small-cap markets, blue-chip companies, and emerging technologies. The company uses technology to enhance workflows but maintains human authorship for all content.

Preliminary findings from the phase 1b CC-220-DLBCL-001 trial show that combining golcadomide (0.4 mg) with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) is well-tolerated and yields high metabolic response rates in previously untreated aggressive B-cell lymphoma patients. The 0.4-mg dose achieved an 88% complete metabolic response rate, with promising 12-month progression-free survival in both overall and high-risk groups. Golcadomide, a first-in-class oral CELMoD agent, demonstrated a toxicity profile similar to R-CHOP and maintained good dose intensity.

Health Ministry approves BPaLM regimen, a shorter, more effective treatment for MDR-TB, consisting of Bedaquiline, Pretomanid, Linezolid, and Moxifloxacin, curing drug-resistant TB in six months with high success rates and cost savings.

Intelligent Bio Solutions (INBS) announces progress in its clinical study plan, aiming for FDA 510(k) submission for non-invasive drug screening tech by late 2024. The company is conducting a method comparison study with CenExel, comparing fingerprint sweat opiate screening with LC-MS/MS methods, with completion targeted for September. The technology promises quick, hygienic, and accurate drug screening.

The study developed parametric drug–disease models using pooled clinical trial data to estimate patient-/disease-related factors and drug-specific properties, then explored how baseline characteristics influence treatment performance. Key findings include: higher baseline ACQ-5 scores linked to poorer asthma control and higher exacerbation risk; male non-smokers with BMI < 25 kg/m² and no recent exacerbations had lower risk compared to female smokers with BMI ≥ 25 kg/m² and prior exacerbations; smokers used more reliever medication; ACQ-5, BMI, and smoking status influenced immediate symptoms and exacerbation risk; FF/VI treatment showed lower exacerbation risk and higher reduction in reliever use compared to BUD/FOR; model-based approach distinguished patient-/disease-specific features from drug-specific properties; simulation scenarios indicated stepping up to FF/VI combination therapy could significantly reduce exacerbation risk; personalized management should consider factors like high BMI, low FEV1, exacerbation history, and female sex.

FDA official clarifies cGMP expectations for investigational drugs.

Laboratory mice with Alzheimer’s-like cognitive issues showed improved memory after treatment with a new drug targeting neuroinflammation-related brain proteins, potentially offering a breakthrough in Alzheimer’s treatment.

Daiichi Sankyo and Merck's ifinatamab deruxtecan shows 54.8% ORR at 12 mg/kg in pretreated ES-SCLC patients, selected as optimal dose for IDeate-Lung01 phase 2 trial extension and IDeate-Lung02 phase 3 study.

Cannabidiol (CBD) extends lifespan and alleviates symptoms in Leigh syndrome animal models, improving mitochondrial function and neurological health.