Tag: Clinical trial

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STAT+: Oruka’s long-acting psoriasis therapy posts strong results in mid-stage study

A long-acting injectable treatment for plaque psoriasis helped 63% of patients achieve complete skin clearance in a mid-stage clinical trial, its maker, Oruka Therapeutics, reported Monday. 

Separately, Oruka said an updated analysis of blood exposure levels supported the potential for the drug, ORKA-001, to be injected just once per year. 

Oruka still needs to conduct late-stage clinical trials, but Monday’s results bolster ORKA-001’s potential to become a new treatment for the autoimmune skin disease with remission rates equal to or greater than current commercial blockbusters Skyrizi and Bimzelx, while requiring fewer injections.

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STAT+: Veradermics’ hair loss drug succeeds in late-stage trial

An oral medicine for hair loss successfully spurred hair growth in a late-stage trial, startup Veradermics announced Monday.

Veradermics assessed the pill in two ways: by how many hairs grew within a square centimeter of the scalp, on average, and by how satisfied participants were with the results. Over the course of six months, men who took the drug, known as VDPHL01, either once or twice daily had between 30 and 33 more hairs per square centimeter of scalp. Men in the placebo group grew approximately seven additional hairs.

Between 79% and 86% of men taking VDPHL01 said they saw improvement, along with between 72% and 84% of the clinical trial investigators — results that pleased Reid Waldman, a dermatologist turned Veradermics’ chief executive.

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Effect of a WeChat Intervention Based on the Common-Sense Model on Breast Cancer–Related Lymphedema Preventive Behaviors: Quasi-Experimental Study

Background: Breast cancer–related lymphedema is the most prevalent postoperative complication among breast cancer survivors. Although mobile health tools are increasingly used for patient education, evidence supporting their efficacy in lymphedema prevention remains limited. Objective: This study aimed to evaluate the effectiveness of a WeChat-based intervention grounded in the common-sense model (CSM) in improving preventive behaviors, modifying illness perceptions, and reducing lymphedema incidence among breast cancer survivors and to validate the targets of the intervention. Methods: This study used a quasi-experimental design. Participants (N=192) were recruited from the breast cancer department of a cancer hospital in Guangzhou, China. The control group (n=98) received routine care. The intervention group (n=94) participated in a 3-month CSM-guided WeChat mini-program (“Nantian e-Care”) delivering tailored educational articles, exercise tutorials, arm circumference monitoring, and real-time nurse consultations. Outcomes, including preventive behaviors, illness perceptions, and lymphedema incidence, were assessed 1, 3, and 6 months post surgery. Generalized estimating equations were used for the analysis. Results: The intervention group exhibited significant improvements in lifestyle adjustments (Wald =6.9, =.03) and physical exercise adherence (Wald =6.9, =.03) compared with the control group. Illness perception, including identity (Wald =8.1, =.04), timeline cyclical (Wald =8.5, =.04), personal control (Wald =9.3, =.03), illness coherence (Wald =29.8, <.001), and behavioral (Wald =19.5, <.001) and physical factors (Wald =24.1, <.001) were markedly enhanced. Mechanistically, skin care improvements were driven by intervention effects, personal control, illness coherence, and behavioral attribution. Lifestyle changes were correlated with intervention and illness coherence. Adherence to physical exercise was not statistically significantly affected by the intervention, although a trend was observed. Critically, the intervention group demonstrated a lower incidence of lymphedema at 6 months (7.50% vs 16.48%, =3.9, =.048). Conclusions: The CSM-guided WeChat intervention effectively promoted preventive behaviors, optimized illness perceptions, and reduced lymphedema risk. These findings underscore the value of integrating theory-driven mobile health tools into postoperative care and highlight scalable strategies for chronic disease management in resource-limited settings. Trial Registration: Chinese Clinical Trial Registry ChiCTR2100048798; https://www.chictr.org.cn/showprojEN.html?proj=130038 International Registered Report Identifier (IRRID): RR2-10.1007/s00520-024-09078-x
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Targeted therapies plus radiotherapy for diffuse intrinsic pontine glioma: the randomized phase 2 BIOMEDE trial

Nature Medicine, Published online: 24 April 2026; doi:10.1038/s41591-026-04354-1

In a biomarker-driven trial evaluating radiotherapy with erlotinib, everolimus or dasatinib in patients with newly diagnosed diffuse intrinsic pontine glioma, the primary endpoint of overall survival was not met, but features associated with long-term survival were defined, and everolimus emerged as a potential candidate for further testing.

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Expected Competencies and Personal Attributes of Digital Health Navigators to Support Digital Mental Health Care: Focus Group and Interview Study With Patients and Health Care Professionals

Background: Digital mental health apps (DMHAs), and in particular digital therapeutics (DTx), offer promising opportunities to support mental health care. However, their effective use in outpatient settings in Germany remains limited. To overcome this gap, the role of digital health navigators (DHNs) has been introduced. DHNs are trained individuals who support patients and health care professionals in selecting, using, and integrating DMHAs into care. Despite increasing interest in this role, there is limited evidence on the competencies, knowledge, and personal attributes required for DHNs to work effectively in mental health settings. Objective: The study aims to explore the expected competencies, knowledge areas, and personal attributes that DHNs need to effectively support the implementation and use of DTx in outpatient mental health care. Methods: As part of the prestudy of the Digital Navigators for Acceptance and Competence Development with Mental Health Apps (DigiNavi) study, a qualitative study was conducted involving 35 participants (7 general practitioners, 8 patients in general practice, 11 outpatient psychiatrists/psychologists, and 9 patients in psychiatric outpatient clinics) from different general practices and psychiatric outpatient clinics in Germany. A total of 17 semistructured interviews and 4 focus groups were conducted to explore expectations of DHNs. Data were analyzed using qualitative content analysis. Results: Participants emphasized that DHNs should combine strong interpersonal skills (empathy, patience, and sensitive communication) with technical and basic clinical competencies. Most favored DHNs as integrated clinical team members (eg, medical assistants), citing their existing patient relationships, but noted time and training constraints. Key expectations included the ability to support patients with DTx use, adapt communication to individual needs, and convey data privacy information clearly. Foundational knowledge of mental health conditions and sensitivity to crises were considered important for identifying warning signs and escalating concerns. While DHNs were seen as essential intermediaries between patients, health care professionals, and DTx, participants highlighted the necessity for clearly defined roles, structured training, and realistic expectations to prevent role overload and enable sustainable implementation in outpatient mental health care. Conclusions: DHNs require a specialized skill set that bridges clinical understanding, digital expertise, and interpersonal competence. Our results lay the groundwork for developing training curricula and implementation strategies that align with real-world expectations for the DHN role. Defining these core competencies is essential for supporting the sustainable and effective integration of DMHAs into mental health care. Trial Registration: German Clinical Trials Register DRKS00034327; https://drks.de/search/en/trial/DRKS00034327 and ClinicalTrials.gov NCT06575582; https://clinicaltrials.gov/study/NCT06575582 International Registered Report Identifier (IRRID): RR2-10.2196/67655
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STAT+: From Revolution Medicines, more strong data on KRAS drug and a glimpse of a ‘novel class’ beyond it

SAN DIEGO — Revolution Medicines is already cooking up the next iteration of RAS inhibiting drugs.

At the American Association of Cancer Research annual meeting here, the company is the talk of the town for the clinical trial success of daraxonrasib, its next generation targeted therapy, in advanced pancreatic cancer. And while the company presented more data on that drug Tuesday, showing promising first line and combination data on daraxonrasib, scientists also showed in another session intriguing preclinical data on a completely new compound that may represent what comes after the current lineup.

That drug, currently called RM-055, is what RevMed CEO Mark Goldsmith is calling an entirely “novel class of catalytic inhibitors.” These are targeted therapies that not only block the RAS signaling that drives cancer, but molecularly turn the cancer protein off.  

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STAT+: BioAge says experimental pill aimed at reducing heart risks significantly reduced inflammation

BioAge Labs said Tuesday that its investigational pill for cardiovascular risk prevention significantly reduced inflammation in an early study, as more drug companies target inflammation as a way to treat a range of chronic conditions.

In a Phase 1 study of people with obesity and elevated inflammation levels, patients taking a 60-milligram dose of the drug, called BGE-102, experienced an 86% reduction in a measure of inflammation called high-sensitivity C-reactive protein (hs-CRP) after three weeks. That’s a similar level of reduction seen in patients who took a higher 120-mg dose in the study, which the company previously reported. 

Additionally, 87% of patients taking the 60-mg dose achieved hs-CRP levels of less than 2 mg/liter, the threshold thought to be associated with a lower risk of cardiovascular complications.

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