Latest news with #ClinicalTrialsArena
Yahoo
21 hours ago
- Business
- Yahoo
Enrolment concludes in Halia's Phase IIa trial of HT-6184 for MDS
Halia Therapeutics has completed the enrolment in its Phase IIa trial of HT-6184 (Ofirnoflast) in those with lower-risk myelodysplastic syndrome (MDS). The two-stage trial is designed to test the therapy in individuals who are intolerant of, refractory to, or ineligible for erythropoiesis-stimulating agents (ESA). It will assess the safety, biomarker response, and efficacy of this allosteric modulator of NEK7, targeting a key inflammatory pathway associated with bone marrow dysfunction in MDS. The trial has enrolled 18 subjects in stage I and an additional 15 in stage II. It includes a 16-week treatment duration, with a continuation phase based on patient response followed. Those who respond might continue therapy, while those who did not, with > 30% reduction in variant allele frequency clone size, could receive further treatment either as a single agent or in conjunction with previous ESA therapy for 16 extra weeks. The main objectives of the study are to assess efficacy via haematological improvement, VAF reduction, clonal suppression, safety, biomarker changes, quality of life, and patient tolerance. Halia noted that an interim analysis after stage I has been conducted, and topline outcomes are anticipated later in the year. Halia Therapeutics CEO Dr David Bearss said: 'Completing enrolment in our Phase IIa MDS study is a major milestone as we continue to validate our mechanism of action targeting innate immune dysregulation. 'This study provides important proof-of-concept data to support the therapeutic potential of HT-6184 in reducing clonal inflammation and improving haematologic outcomes for patients with symptomatic anaemia.' Halia focuses on developing therapies that help restore immune balance in neurodegenerative and inflammatory conditions. Its pipeline also includes HT-6184 plus semaglutide for a planned Phase IIa trial in obesity and Type 2 diabetes, anticipated to start in the third quarter of this year, and HT-4253 for neuroinflammation, currently in a Phase I trial. The company began the Phase II trial last year to investigate HT-6184 in managing post-procedural inflammatory and pain responses. "Enrolment concludes in Halia's Phase IIa trial of HT-6184 for MDS" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
4 days ago
- Business
- Yahoo
ASCO25: Novartis hopes Scemblix becomes new standard for CML-CP
Novartis is hoping that Scemblix (asciminib) will become the physician's first choice of therapy for chronic myeloid leukaemia in chronic phase (CML-CP) after it has shown to be more tolerable than the standard of care (SOC) in a Phase IIIb trial. Scemblix is a first-in-class STAMP inhibitor which received accelerated approval by the US Food and Drug Administration (FDA) in 2021 in previously treated CML in adult patients. On 29 October 2024, the FDA granted accelerated approval to the drug as a first-line therapy in CML-CP. Interim data presented at the American Society of Clinical Oncology (ASCO) 2025 meeting, held from 30 May to 3 June in Chicago, from the ongoing ASC4START (NCT05456191) study showed the drug met its primary endpoint of superior tolerability. In the study, 120 patients were randomised to receive either Scemblix 80mg daily or nilotinib 300mg twice daily, a SOC tyrosine kinase inhibitor (TKI), with the primary endpoint looking at treatment discontinuation due to adverse events (AEs) or treatment-related deaths. Patients were evaluated for an average of 9.7 months with this preliminary data cutoff happening after 50 trial-reported AEs. At this cutoff, 10.9% of patients on Scemblix had discontinued treatment compared with 17.3% of patients on nilotinib, achieving the primary endpoint with a cause-specific hazard ratio of 0.45. Novartis added that the study is ongoing with further analyses planned for tolerability and efficacy of Scemblix with a 65-event cut-off. It follows the ASC4FIRST study (NCT04971226) for efficacy in which Scemblix outperformed SOC TKI with a major molecular response (MMR) rate of 74.1% at week 96 compared with 52% for those on SOC TKIs after 96 weeks of treatment. The company hopes this additional tolerability data will support physician preference for Scemblix as a first-line therapy for patients with CML-CP. While the data may convince physicians, its ability to become SOC will depend on the agencies and payers said Dr. Andreas Hochhaus, principal investigator and director of the University Tumor Center (UTC) at the Jena University Hospital, Germany. Speaking to Clinical Trials Arena, Hochhaus said: 'We did this study to convince the agencies in different countries for reimbursement because SOC means you need reimbursement, and it's important to show all kinds of data and that means efficacy, but also tolerability. In CML, we have improved survival almost to the survival expectation of the normal population. Therefore, this cannot be improved anymore, so you need other endpoints such as quality of life and AEs..' "ASCO25: Novartis hopes Scemblix becomes new standard for CML-CP" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
7 days ago
- Business
- Yahoo
ASCO25: Merck KGaA's ADC shows safety and tolerability in colorectal cancer trial
Merck KGaA's antibody-drug conjugate (ADC), precemtabart tocentecan, has shown to be safe and tolerable in a Phase Ib trial. The ongoing PROCEADE-CRC-01 study (NCT05464030) is investigating the dose, safety and tolerability of intravenous (IV) precemtabart tocentecan in approximately 200 patients with metastatic colorectal cancer (mCRC). The study is also looking at early signs of efficacy. Two doses of the drug, 2.4mg/kg and 2.8mg/kg, are being investigated, with patients dosed every three weeks. Merck KGaA is presenting the data during the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from 30 May to 3 June 2025 in Chicago, Illinois. As of the March 25 data cut-off, 42% of patients enrolled in the dose expansion phase of the Phase Ib study remain on treatment, with three patients having continued treatment for nine months. The median duration of response (DoR) is 23.3 weeks, with nearly 60% of patients having had six cycles of treatment. The median progression free survival (PFS) is 6.9 months, and there was a 72% disease control rate at week 12. In the study, the most common adverse events (AEs) were anaemia and neutropenia, with no cases of interstitial lung disease (ILD) or ocular toxicity noted in the study. There were no discontinuations or treatment related deaths. One of the investigators, Scott Kopetz from the MD Anderson Cancer Center said: 'This ADC compares favourably versus the current monotherapy in third-plus line treated mCRC where response rates are in the single digits. Therefore, we think this represents a very active regimen, even in patients that have been previously treated with irinotecan as we're seeing in this population.' Precemtabart tocentecan is an anti-CEACAMS that acts by selectively delivering a cytotoxic topoisomerase 1 inhibitor payload (exatecan). Beyond mCRC, it is being investigated in several oncology indications with CEACAM5 expression, including gastric cancer (GC), non-small cell lung cancer (NSCLC), and pancreatic ductal adenocarcinoma (PDAC) in the ongoing Phase Ib/II PROCEADE-PanTumor study (NCT06710132) Merck KGaA added that the data supports advancing precemtabart tocentecan in mCRC, with plans to move ahead with the 2.8kg/mg dose. Merck KGaA has another ADC, M3554, in Phase I clinical trials and two ADCs in preclinical development. According to GlobalData analysis, the ADC market was valued at $8.6bn in 2023, with expectations to exceed $45bn by 2030. There are already several blockbuster drugs on the market such as Roche's Polivy (polatuzumab vedotin), Gilead Science's Trodelvy (sacituzumab govitecan), and Daiichi Sankyo/AstraZeneca's Enhertu (trastuzumab deruxtecan), with Enhertu being the highest grossing ADC of the year. GlobalData is the parent company of Clinical Trials Arena. "ASCO25: Merck KGaA's ADC shows safety and tolerability in colorectal cancer trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
30-05-2025
- Business
- Yahoo
WCG launches integrated solution to enhance clinical trial process
WCG has launched the WCG Study Accelerator, an integrated solution designed to optimise the clinical trial process and enhance outcomes for institutions and sponsors worldwide. The solution focuses on expediting the execution of trials by aligning site choices, ethical reviews, and subject recruitment and retention into a unified strategy. It uses operational intelligence and real-time data to reduce risks, prevent engagement with underperforming sites, and shorten trial timelines by up to 20%. This approach allows sponsors to make informed site selections and improve enrolment efficiency. WCG chief operations officer Mark McDonald said: 'Study Accelerator not only provides a structured framework for executing trials efficiently, but also embeds flexibility and insights by streamlining site selection and participant enrolment and engagement processes. 'The solution combines advanced technology with hands-on support to ensure seamless implementation and execution, even for highly specialised or complex protocols. This truly enables smarter, faster trials.' According to the company, operational challenges, rather than scientific uncertainty, often cause delays in the trials. Issues such as disjointed planning, inconsistent execution of the site, and last-minute efforts to meet enrolment targets can lead to time wastage, increased expenses, and jeopardised outcomes. The solution is specifically engineered to solve these issues by integrating core operational functions into a performance-oriented framework that enhances decision-making, minimises obstacles, and enables trial advancement. WCG CEO Sam Srivastava said: 'With the launch of WCG Study Accelerator, we are addressing the well-known bottlenecks that have plagued clinical trials for years. Our solution exemplifies our commitment to innovation and customer-centricity by providing a model that propels trial execution forward with precision, speed, and integrity.' In March 2025, WCG launched ClinSphere Total Feasibility, a software-as-a-service (SaaS) platform aimed at refining site selection processes to aid sponsors and contract research organisations in making more decisions during clinical trial start-ups. "WCG launches integrated solution to enhance clinical trial process" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
26-05-2025
- Health
- Yahoo
Mineralys reports outcomes from trial of lorundrostat for hypertension
Mineralys Therapeutics has reported outcomes from its pivotal randomised, placebo-controlled Phase III Launch-HTN trial assessing lorundrostat for controlling hypertension. This global, double-blinded trial involved more than 1,000 subjects having uncontrolled or resistant hypertension (uHTN or rHTN), who were on two to five antihypertensive medications. Subjects were randomised and given either a placebo, lorundrostat 50mg once daily, or a dose of lorundrostat 50mg and titrated to 100mg at week six. Change from baseline in systolic blood pressure against placebo post six weeks of treatment is the primary endpoint of the trial. It was met showing a decrease in placebo-adjusted systolic blood pressure from baseline at week six. Lorundrostat dosed at 50mg once a day minimised automatised office systolic blood pressure. At week six, subjects experienced a 16.9 mmHg reduction, with a further decrease to 19 mmHg by week 12, compared to placebo. The trial's design reflected real-world clinical settings, using automated office blood pressure (AOBP) measurement and enabling subjects to maintain their current medication regimens. According to the company, lorundrostat's tolerability and safety profile was favourable, with modest on-target effects on serum electrolytes, which were quickly reversible upon discontinuation. Notably, cortisol production suppression was not observed, and there were very few serious adverse events related to the drug that required discontinuation or adjustments of dosage. Lorundrostat is an oral aldosterone synthase inhibitor targeting the treatment of hypertension, obstructive sleep apnoea, and chronic kidney disease. Mineralys Therapeutics CEO Jon Congleton said: 'The detailed results from Launch-HTN, which was designed to reflect treatment in the real-world setting, mark a pivotal milestone in our mission to deliver the first targeted aldosterone synthase inhibitor to the millions of people suffering from uncontrolled or resistant hypertension. 'With these findings in hand, we now have data from two pivotal trials in distinct-but-complementary populations that reinforce the promise of a new treatment approach for hypertension that directly addresses the dysregulated aldosterone pathway – a key driver of the condition in many patients.' In March this year, lorundrostat met the primary endpoint in two pivotal trials. "Mineralys reports outcomes from trial of lorundrostat for hypertension" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
