Clinical Trials

In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.

The US precision medicine company hopes its drug response predictor technology will enhance responses to the chemotherapy Ixempra on the basis of promising data from a handful of breast cancer patients in a Phase II trial, marking a positive turn in its journey to date.  

Shanghai Henlius Biotech is planning to move forward with wet AMD trials for its bevacizumab biosimilar rival to Avastin following a nod from the US FDA.

In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.

Tumor infiltrating lymphocyte therapies show promise for solid tumors, with a first FDA approval, but face manufacturing and access challenges as development continues.

With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.

The nod will help unlock a national market for the partners’ Dupert (fulzerasib) in which roughly 50,000 people are expected to be newly diagnosed with lung cancer harboring the KRAS G12C mutation in 2025. Meanwhile, two other homegrown rivals are also closing in on marketing clearances in China.

A disastrous Phase II miss for the pulmonary arterial hypertension candidate AV-101 leaves Aerovate drifting. Could Gossamer stand to benefit?    

GLP-1 receptor agonists could play a big role in tackling neurodegeneration and a new academic study has raised expectations of Novo Nordisk’s latest semaglutide Phase III results

Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

Attendees at this year's European Society for Medical Oncology meeting in Barcelona can look forward to a range of interesting datasets, from Phase III trials of established products in new settings to preliminary studies of novel products coming through the pipeline.  

The commercial implications of the miss are hard to call, but separate trials could offer hope.    

Chinese firm Sciwind has revealed additional Phase III findings for its promising once-weekly GLP-1 agonist ecnoglutide, just one asset in a burgeoning Chinese sector that could see the emergence of new rivals to current global leaders in obesity and diabetes.

The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.

The FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion; Intercept’s COBALT trial of obeticholic acid was negatively impacted by product safety labeling changes and a high crossover rate to commercial drug.

TRiCares announced first implantation of the Topaz transfemoral tricuspid heart valve replacement system as part of the company’s EU pivotal study. If all goes to plan, the device will compete with Edwards’ Evoque system. The announcement follows the company’s $50m series D funding raise in July.

J&J acquired Taris in 2019 to gain access to TAR-200 and its drug delivery platform. Now, early clinical data suggest the product could delay or remove the need for cystectomy in several bladder cancer settings and the US healthcare giant is eyeing multi-blockbuster sales.    

The Barcelona meeting saw early data from two candidates from Incyte and Pfizer which suggest some progress for a new drug mechanism that has so far underwhelmed.    

New Phase II data for the bispecific antibody show promise in colorectal cancer as the company seeks to spread the bispecific antibody’s wings. Phase III trials are on the horizon, where it will need to go up against standard of care.    

Click Therapeutics reports positive Phase 3 clinical data for CT-132, a digital therapeutic intended as an adjunctive treatment of episodic migraine. The company is pursuing FDA clearance and actively exploring opportunities to offer a drug-digital combination therapy with added clinical benefit that provides “a single, integrated experience for the patient, prescriber and payer.”