An Insight on Significant January 2024 Clinical Trials

Clinical trials play a vital role in improving patient care, advancing medical knowledge, and developing new treatment alternatives for the patients. While offering a deeper insight into safety and effectiveness of new drugs, they also provide evidence-based data and contribute to the development of personalised medicines by devising strategies tailored to individual patient characteristics. As a result, there has been continuous progressions, with new drugs undergoing clinical trials every now and then.

Let’s Explore the Latest and Significant Drug Approvals of January 2024

Coherus Biosciences’ New Targeted Antibody Showcases Potential in Liver Cancer Treatment

A selective and potent human anti-IL-27-targeting antibody called casdozokitug (casdozo), when used in combination with atezolizumab (atezo) and bevacizumab (bev) was well tolerated in patients affected by liver cancer. According to the data presented 2024 ASCO Gastrointestinal Cancers Symposium, that took place on January 18th, 2024, the drug demonstrated an overall response rate of 38%. It also included 3 complete responses along with an additional favourable safety profile supporting its application for disease treatment. Developed by Coherus Biosciences, Casdozokitug was administered to 30 patients, wherein safety and tolerability were the primary endpoints, while overall response rate as well as disease control rate were secondary endpoints.

Liver cancer has a significantly higher incidence, leading to a subsequent therapeutics market share. As per EMR estimations, the liver cancer therapeutics market size is poised to reach approximately USD 22 billion by 2032, following a consistent growth rate of 19.85% between 2024-2032.

Nanotechnology based Drug Displays Promising Outcomes in Cancer Treatment

The rising application of modern technologies such as nanotechnology in drug development is anticipated to transform the pharmaceutical landscape in the near future. In January 2024, Nanoform Finland Plc announced positive clinical results from their pioneer nanoformulation drug products. Used as an alternative to the amorphous solid dispersion (ASD) used in Xtandi (an androgen receptor inhibitor used in prostate cancer treatment) nanocrystalline-enabled enzalutamide (nanoenzalutamide) showed improved bioavailability.

This drug has been developed in collaboration with the ONConcept® Consortium (Bluepharma, Helm, and Welding) whereby the application of controlled expansion of supercritical solutions (CESS®) technology offers an improved and differentiated finished product, leading to better drug efficacy. In a randomised, single-dose, comparative bioavailability study, conducted by an American CRO (contract research organization), enzalutamide 160mg filmcoated tablets (Bluepharma) showed potency against Xtandi® 4x40 mg film-coated tablets (Astellas Pharma Europe B.V.). Helm and Nanoform have already filed a patent application for the drug.

Atacicept by Vera Therapeutics Shows Positive Outcomes for Managing Gd-IgA1 and Hematuria

On 25th January 2024, Vera Therapeutics, Inc., announced the positive 72-week data from the open-label extension (OLE) period of its Phase 2b ORIGIN clinical trial of atacicept in patients with IgA nephropathy, wherein it showcased significant and consistent reductions in Gd-IgA1, hematuria, and UPCR. It was well tolerated in the OLE (open-label extension). Participants treated with the drug observed a notable 62% reduction in Gd-IgA1, while there was a significant percentage decrease in hematuria by 19% along with a 48% reduction in urine protein to creatinine ratio (UPCR). Following the promising results, several participants shifted from placebo to atacicept and indicated significant reductions in the disease.

Atacicept is a recombinant fusion protein containing calcium-modulating cyclophilin ligand interactor (TACI) receptor and transmembrane activator, which attaches to the cytokines B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL). It has been successfully administered to over 1500 patients and shows promising impact to treat the several fatal indications in patients.

Hope for Lung Cancer Treatment as Novel Drug Candidate Helps in Precise Tumor Visualisation

In January 2024, Vergent Biosciences, a clinical stage biotechnology firm took The Society of Thoracic Surgeons Annual Meeting stage to showcase the efficacy of VGT-309, a tumor-imaging agent to visualise primary and advanced lung tumor during the surgery. As per the results of the ongoing Phase 2 multi-center VISUALIZE study, the candidate can be used to assist surgeons in finding undetected tumor areas. In Phase 2 efficacy study, it improved the surgical outcomes in 40 patients with supposed or proven lung cancer.

Lung cancer is a highly prevalent cancer type, expected to affect around 1 in 16 individuals in their lifetime. According to EMR calculations, the global intraoperative imaging market is expected to grow at a steady rate of 5.3% and attain a value of USD 3.4 billion by the year 2032, driven by the increasing prevalence of cancer cases requiring surgical treatment. Developed by the researchers at Stanford University School of Medicine, VGT-309 is enabled for complete tumor visualisation during minimally invasive, open and robot assisted procedures. It covalently binds to cathespins (compounds that are overexpressed across a wide range of solid tumors). Each patient is infused intravenously, few hours before the surgery.

Vertex Pharmaceuticals’ VX-548 Yields Positive Results to Combat Moderate-to-Severe Pain

On January 30th, 2023, Vertex Pharmaceuticals Incorporated released the data from their Phase 3 program, conducted to evaluate the potency of VX-548, a selective NaV1.8 inhibitor to treat moderate to severe pain followed by abdominoplasty and bunionectomy surgery.

The Phase 3 trial included two randomized, double-blind, placebo-controlled, pivotal trials wherein VX-548 showed safety and was well-tolerated in 1,118 patients aged between 18 to 80 years. The drug was orally administered with a preliminary dose of 100 mg, followed by 50 mg every 12 hours. Following the promising results of the medication, the company plans to submit the drug for FDA approval by mid-2024. It has already secured Breakthrough Therapy and Fast Track designations in the United States for treating acute pain.

New Treatment for C. difficile Infection as Ibezapolstat Shows Efficacy over Conventional Drugs

On 17th January 2024, United States based Acurx Pharmaceuticals, Inc., revealed positive results for Ibezapolstat, their leading antibiotic candidate Phase 2b clinical trial in patients with CDI. As per the data provided, ibezapolstat outperformed vancomycin, which is a standard treatment alternative for patients with CDI. It eradicated fecal C. difficile at Day 3 of drug administration in 15 of 16 patients (94%) whereas vancomycin showed fecal C. difficile eradication in 10 of 14 patients (71%).

Moreover, ibezapolstat may prevent infection recurrence by consistently preserving and allowing regrowth of key gut bacterial species expected to aid multiple health benefits. Owing to the promising results of the drug, the company is planning to pass the drug onto Phase 3 trials and is already in talks with profound regulatory authorities including EMA and the United States FDA. More results are expected to arrive by Q1 2024.

According to EMR, the global oral antibiotics market is expected to reach an estimated value of USD 23.1 billion by the year 2032, growing at a CAGR of 2.5% between 2024-2032.

Continuous medical research and pharmaceutical development is the backbone of the medical industry. As a result, these clinical trials display a significant trend of rising technological advances and research initiatives to develop highly effective medicines and provide and cater to the unmet demands of the masses.