Trial data

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates.  The most impactful drug discovery news this week is all linked with scientific research data. Analysts Phesi revealed that a third of clinical […]

News round-up for 17-21 July by DDW Digital Content Editor Diana Spencer. The most impactful drug discovery news this week is all linked with scientific research data. Analysts Phesi revealed that a third of clinical development programmes are cancelled during Phase II, and there were significant trial results for drugs for head and neck cancer […]

Shares in AstraZeneca fell by 6% on July 3 when the company published the first results from its Phase III trial for datopotamab deruxtecan (Dato-DXd) and continued to fall throughout the day, though there was some recovery on July 4. It was reported that the therapy demonstrated statistically significant improvement in progression-free survival vs docetaxel […]

New data from Boehringer Ingelheim and Zealand Pharma has demonstrated superior efficacy with survodutide (also known as BI 456906) versus placebo in people with overweight or obesity without type 2 diabetes after 46 weeks of treatment. The findings were presented at the 2023 American Diabetes Association’s 83rd Scientific Sessions in San Diego, CA, US. The primary […]

Janssen has announced positive results from the proof-of-concept Phase II UNITY trial for the treatment of pregnant individuals at high risk of early-onset severe (EOS) haemolytic disease of the foetus and newborn (HDFN). A statistically significant (54%) proportion of participants who received nipocalimab achieved the primary endpoint of a live birth at or after gestational […]

Takeda has revealed favourable interim results from its Phase III crossover trial evaluating the safety and efficacy of TAK-755 (recombinant ADAMTS13) replacement therapy for the prophylactic treatment of congenital thrombotic thrombocytopenic purpura (cTTP). cTTP is an ultra-rare, chronic and debilitating blood clotting disorder caused by a deficiency in ADAMTS13 enzyme. Clinical presentation of cTTP lies […]

PTC Therapeutics has shared interim data from the 12-week portion of the PIVOT-HD Phase II study of PTC518 in Huntington’s disease (HD) patients. The study demonstrated dose-dependent lowering of Huntingtin (HTT) protein levels in peripheral blood cells, reaching a mean 30% reduction in mutant HTT levels at the 10mg dose level. In addition, PTC518 exposure […]

The independent Data Monitoring Committee (DMC) has recommended the continuation of Algiax Pharmaceuticals’ Phase IIa study with lead candidate AP-325 in chronic neuropathic pain. Based on the positive DMC review and confirmed financial commitment from its investors, the company will expand the trial to Belgium, France, and Italy. The study is continuing as planned with […]

New data has revealed a long-term response in patients with advanced non-small cell lung cancer (NSCLC) taking Rybrevant (amivantamab). The CHRYSALIS study is evaluating amivantamab in patients with advanced non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease progressed on prior platinum-based chemotherapy. Data from the study […]

Intercept Pharmaceuticals’ obeticholic acid (OCA) could be first drug to be approved in the US for non-alcoholic steatohepatitis (NASH), according to analysts GlobalData.  The Food and Drug Administration (FDA) accepted the company’s resubmission of its new drug application (NDA) for OCA in patients with pre-cirrhotic liver fibrosis due to NASH in December 2022.  According to […]

Greater data-centricity, supported by new technologies, is key to driving efficient product approvals and supply chains. Frits Stulp and Aida Demneri, partners at Deloitte (including Iperion – a Deloitte business), outline how life sciences companies can play their part in driving change. In the past two years, EU regulatory authorities accelerated processes so that vaccines […]

Immutep has revealed encouraging initial clinical data from two trials investigating its lead product candidate eftilagimod alpha in non-small-cell lung cancer.  Findings from the trials were shared at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2022.   The INSIGHT-003 trial is evaluating eftilagimod alpha as part of a triple combination therapy with standard-of-care anti-PD-1 […]

Psilocybin, a psychedelic derived from mushrooms, has been proven effective as a therapy for treatment-resistant depression (TRD) in the largest study of its kind.  The results of COMPASS Pathways’ Phase IIb trial have been published in The New England Journal of Medicine (NEJM).  The data show that after a single 25mg dose of COMP360 psilocybin, […]