May 2024 Clinical Trials Analysis: Latest Trends and Insights in the Healthcare Industry

Clinical trials are the key driver of medical innovation and promise to bring in a new era of advancements in the healthcare sector. They are pivotal in addressing both existing and emerging health challenges by introducing revolutionary therapies for the growing patient pool. By establishing more effective and sustainable treatment options, successful clinical trials have the potential to combat rising chronic disease burden as well as reduce long-term healthcare costs.

Let’s explore the latest and most significant clinical trials of May 2024.

Australian University Launches a New Clinical Trial to Reduce Independent Risk Factor in Heart Disease

On May 15, 2024, it was reported that University of the Sunshine Coast (Queensland, Australia) researchers are conducting a clinical trial to assess a potential new treatment that is indicated to reduce high levels of a blood lipoprotein, known to result in clogged arteries and cardio-cerebrovascular diseases. The novel therapeutic product is expected to target Lipoprotein (a), which doesn’t respond to cholesterol-lowering medications and is an independent risk factor for cardio-cerebrovascular disease from hardened arteries. The clinical trial is recruiting eligible candidates with elevated lipoprotein (a) and will evaluate the safety, tolerability, and side effects of the investigational treatment.

Recent data reveals that 1 in 5 people are estimated to have elevated lipoprotein (a), which can lead to heart disease. The introduction of such promising treatments is poised to stimulate the cardiovascular drugs market growth and improve patient outcomes. According to EMR calculations, the cardiovascular drugs market size is anticipated to grow at a CAGR of 2.7% during the forecast period of 2024-2032 and is likely to reach a market value of USD 84.47 billion by 2032.

UC Davis Health Participates in CAR T-cell Therapy Clinical Trial for Lupus Treatment

In May 2024, UC Davis Health announced that it is one of the nine institutions globally and the only one in the Western United States to participate in the industry-funded clinical trial investigation of a new single-dose infusion CAR T-cell therapy indicated for treating lupus (a chronic autoimmune disorder). The academic health center has partnered with T-cell therapy developer Cabaletta Bio to assess the company's chimeric antigen receptor CAR T-cell therapy, CABA-201, in systemic lupus erythematosus (SLE) or lupus nephritis (LN) patients who have active disease. In the trial, the CABA-201 cells will be infused into the participant’s body to eliminate the “bad” B cells which might enable healthy B cells to repopulate in the patient's body.

According to the Lupus Foundation of America, at least 5 million people worldwide and around 1.5 million Americans are living with lupus, reflecting the need for targeted treatment options for managing this autoimmune disease. If Cabaletta Bio’s one-time CAR T-cell treatment proves to correct the underlying defect or provide long-term remission for lupus nephritis, it can drastically improve the lives of lupus patients and spur the demand for lupus nephritis treatment market.

Clinical Trial of Personalized Cancer Vaccines Aim to Prevent Cancer Recurrence

In England, thousands of patients are gaining access to the ongoing clinical trial of personalized cancer vaccines under the NHS “matchmaking” scheme. This initiative called the Cancer Vaccine Launch Pad allows eligible patients who pass certain criteria to immediately enter the new vaccines trial. These personalized cancer vaccines are customized for each patient in a few weeks and are hailed as a permanent cure for cancer by preventing the disease from coming back. The initial trials will focus on skin, colorectal, bladder, lung, kidney, and pancreatic cancer and might eventually cover other cancer subtypes. BioNTech, a German-based next-generation immunotherapy company, is one of the companies that is partnered with the NHS to successfully conduct the cancer vaccine trial.

The growing demand for cancer vaccines is likely to encourage pharmaceutical companies to invest in and develop new cancer vaccines, which is anticipated to drive innovation and growth in the cancer vaccines market. The EMR report estimates that the global cancer vaccines market size will grow at a CAGR of 11.8% during the forecast period of 2024-2032 and is expected to achieve a value of USD 21.8 billion by 2032.

South Korean Biotech Firm Receives Approval to Initiate Phase 3 Polaris-AD trial for early Alzheimer’s Disease Treatment

On May 11, 2024, South Korean biopharmaceutical company AriBio Co., Ltd. received Investigational New Drug (IND) application approval from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). The approval allows the biotech firm to initiate the Phase 3 Polaris-AD trial of investigational oral agent AR1001 for early Alzheimer’s disease in the country. The trial will assess AR1001, a phosphodiesterase-5 (PDE5) inhibitor, which has demonstrated neuroprotective effects in pre-clinical studies, with findings indicating that it can inhibit neuron apoptosis and restore synaptic plasticity. The primary evaluation indicators of the study include Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13), Clinical Dementia Rating Scale – Sum of Boxes (CDR-SB), changes in cerebrospinal fluid (CSF), and plasma biomarkers, among others.

The trial is expected to enroll early Alzheimer's disease patients across 20 clinical trial centers in China. This Phase 3 clinical trial of AR1001 targets around 1,150 participants in over 200 clinical centers and the inclusion of China represents a significant milestone in developing innovative treatments for Alzheimer's and other neurodegenerative diseases.

Orbsen’s New Stromal Cell Therapy Undergoing Phase 2 Trial for Chronic Inflammatory Diseases

In May 2024, it was reported that a Phase 2 trial (POLARISE trial) to evaluate a novel stromal cell therapy was being conducted by the University of Birmingham. It is funded by the Innovate UK grant for managing inflammation and symptoms in patients with certain autoimmune diseases such as primary sclerosing cholangitis and rheumatoid arthritis. The POLARISE trial aims to evaluate the efficacy and safety of intravenously administered stromal cell therapy ORBCEL developed by Orbsen Therapeutics Ltd, a leading mesenchymal stromal cell therapy company based in Ireland.

This Innovate UK-funded POLARISE trial indicates a strategic collaboration between the University of Birmingham and Orbsen Therapeutics to evaluate Orbsen’s ORBCEL therapy. Such collaborative initiatives are poised to foster advancement in cell therapies and are likely to drive further research and development in the field.

The clinical trial activity in May 2024 is thriving, shaped by several factors including international collaborations, regulatory approvals, substantial funding, and government initiatives. The rising focus on patent-centric approaches coupled with diverse representation and ethical considerations is likely to enhance the relevance and impact of clinical trials. Moreover, increased public-private partnerships and a positive investment climate are expected to play a crucial role in conducting and sustaining large-scale clinical trials in the coming years.