Comprehensive Overview of Clinical Trials and Related Milestones in Q4 2023

Clinical trials have a pivotal role in pharmaceutical and MedTech domains, significantly enhancing advanced medical knowledge and patient outcomes. These studies are crucial to maintain the efficacy and safety of novel treatments, interventions, and medications. Every trial is a testament to the pursuit of highly effective treatments and therapies, therefore, let’s explore the recent noteworthy clinical trials aimed at shaping better patient care.

AbbVie’s LUMINOSITY Trial Shows Positive Results for Non-Small Cell Lung Cancer (NSCLC)

On November 29th, 2023, AbbVie released their results from the Phase 2 LUMINOSITY trial, conducted to evaluate telisotuzumab-vedotin (Teliso-V) in patients with metastatic non-squamous non-small cell lung cancer (NSCLC), C-Met protein overexpression and epidermal growth factor receptor (EGFR). In the findings, it was revealed that the overall response rate for C-Met high patients was 35% while C-Met intermediate patients displayed 23% positive response rate.

The positive results from the clinical trial can be a groundbreaking treatment alternative as approximately 85% of the lung cancers are classified as NSCLC, under which, 25% of the patients display C-Met protein overexpression.

Genentech’s BTK Inhibitor Fenebrutinib Yields Favourable Data from Phase II FENopta Study

Fenebrutinib, an investigational oral and non-covalent BTK inhibitor, showed positive results in the FENopta study, a Phase II, randomized, and placebo-controlled 12-week study, conducted to analyze the safety and efficacy of fenebrutinib in 109 adults aged 18-55 years with relapsing multiple sclerosis. The drug reduced the total number of new T1 gadolinium enhancing brain lesions by 92% and 90% within a span of 4 weeks along with a reduction of 90% and 95% in T2 lesions in about 8-12 weeks.

Being a dual inhibitor of B-cell as well as microglia activation, Fenebrutinib may be able to reduce disability progression alo ng with disease activity in affected patients.

Izokibep by ACELYRIN, INC., Showed Higher Response Rates than Expected in Psoriatic Arthritis Treatment

ACELYRIN, INC., on November 15th, 2023, announced that Izokibep was well-tolerated in a global phase II trial to treat psoriatic arthritis disease. It is a highly potent, small protein therapeutic designed to inhibit interleukin-17A (IL-17A) with about one-tenth of the size of the monoclonal antibody. The Phase 2 clinical trial, a randomized double-blind, placebo-controlled study, evaluated the safety and effectiveness of izokibep administered at 80 mg every two weeks (Q2W) or 40 mg Q2W, compared to placebo Q2W, in adult patients with active PsA.

Pfizer Gives Hope to Treat Obesity with Medication with Oral GLP-1R Agonist, Danuglipron

On December 1st, 2023, Pfizer released data from their Phase 2b clinical trial, which investigated the application of oral Glucagon-like peptide-1 receptor agonist (GLP-1RA) candidate, Danuglipron to treat obesity in patients. When administered twice daily, the drug displayed statistical reductions from baseline to body weight. The mean reductions ranged from -6.9% to -11.7%, compared to +1.4% for placebo at 32 weeks, and -4.8% to -9.4%, compared to +0.17% for placebo at 26 weeks.

The drug has been designed to maintain blood sugar levels by increasing the amount of insulin released and decreasing the glucagon levels in the blood.

Sanofi and Regeneron Partner to Alleviate COPD with Dupixent (dupilumab)

In a randomized placebo-controlled Phase III NOTUS trial, Dupixent, an interleukin-4 receptor alpha antagonist monoclonal antibody displayed 34% reduction in moderate to severe acute COPD exacerbations over 52 weeks. The NOTUS phase III trial enrolled 935 COPD patients, who were either current or prior smokers.

Regeneron and Sanofi are also working at developing another COPD treatment, an IL-33 inhibiting monoclonal antibody called Itepekimab. This drug is currently under evaluation with results expected to arrive by 2025.

Teva’s Ajovy Displays Favourable Results in the Phase IV Depression and Migraine Trial

With the data unveiled by Teva Pharmaceutical’s UNITE trial, Ajovy (fremanezumab) displayed that patients who were administered with 225 mg subcutaneous Ajovy showed an average of 5.1 lesser monthly migraine days in patients. It also demonstrated significant reductions in depression symptoms with a 6.7 mean drop on the Hamilton Rating Scale for Depression (HAM-D 17). Ajovy is a humanized monoclonal antibody, approved for migraine’s preventive treatment in adults.

Acadia Commences Clinical Trials for Treating PWS with Carbetocin Nasal Spray

On December 1st, 2023, Acadia Pharmaceuticals, started the phase III study ACP-101, carbetocin nasal spray to treat hyperphagia in Prader-Willi syndrome (PWS). The COMPASS 12-weel placebo-controlled trial will administer the 3.2mg spray thrice a day in about 170 children and adults aged 5 to 30 years. Carbetocin has a formulation allowing direct drug delivery to the brain, minimizing the risk of side effects and systemic exposure in the patients.

Novartis' Remibrutinib Shows Promise in Treating Chronic Spontaneous Urticaria (CSU) with Positive Clinical Trial Results.

In Phase III of REMIX-1 and REMIX-2 trials for chronic spontaneous urticaria, Novartis’ Remibrutinib showed positive outcomes by meeting all primary and secondary endpoints. The trial evaluated the drug in individuals whose symptoms were poorly controlled by second-generation H1-antihistamines. Remibrutinib works by blocking histamine release, which is a major factor contributing to symptoms like itching, hives and swelling in the CSU affected patients. It was revealed at the 2023 American College of Allergy, Asthma, and Immunology Scientific Meeting, that the drug showed significant changes at the end of 12 weeks.

In the dynamic pharmaceutical landscape, clinical trials are the forefront of innovation and discovery. With increasing technical breakthroughs and a deeper understanding of human physiology, it is anticipated that the market will flourish with new treatments, refined existing therapies, and uncover unique insights to offer better patient care and foster hope for a healthier future.