Drug Discovery World

NOVEMBER 29, 2023

Pharming’s investigational drug leniolisib is an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor. At sites in the US, Japan, and the EU, the clinical trial will evaluate the safety, tolerability, and efficacy of leniolisib in 15 children, one to six years of age, who have a confirmed APDS diagnosis.

Trials 130

Trials Treatment Clinical Trials FDA 130

Drug Discovery World

JUNE 21, 2023

Citius Pharmaceuticals has revealed positive results from its Phase IIb Study of Halo-Lido (CITI-002) for the treatment of haemorrhoids. Following the 21 st Century Cures Act, higher emphasis is placed on using Patient Reported Outcome (PRO) instruments in clinical trials.

Treatment 130

Treatment Trials Clinical Trials Clinical Development 130

Drug Discovery World

SEPTEMBER 6, 2024

The Phase II NANOBRAINMETS trial of AGuIX has been validated by the Data Safety and Monitoring Board (DSMB) following a futility analysis scheduled after the enrolment and follow-up of 50% of patients in the study. A total of 96 patients have been randomised to date of the 134 scheduled in the study’s protocol.

Trials 130

Trials Clinical Trials Clinical Development Hospitals 130

Drug Discovery World

JANUARY 11, 2024

Verge Genomics has initiated a Phase Ib proof-of-concept study for the treatment of sporadic and familial forms of amyotrophic lateral sclerosis (ALS) with VRG50635. ” The post AI-discovered ALS drug trial uses unique remote monitoring appeared first on Drug Discovery World (DDW). .”

Drug Trials 246

Drug Trials Trials Small Molecule Clinical Trials 246

Drug Discovery World

JULY 4, 2023

New data from Boehringer Ingelheim and Zealand Pharma has demonstrated superior efficacy with survodutide (also known as BI 456906) versus placebo in people with overweight or obesity without type 2 diabetes after 46 weeks of treatment. Current treatments for obesity mainly focus on weight loss by reducing energy intake.

Drug Trials 235

Drug Trials Trials Drugs Treatment 235

Drug Discovery World

AUGUST 19, 2024

CV6 Therapeutics has initiated patient dosing in Phase Ia clinical trial evaluating its investigational first-in-class, specific dUTPase inhibitor CV6-168 + infusional 5-fluorouracil (5-FU). In preclinical studies, the drug has demonstrated robust anti-tumour activity in cell line and animal models with no added toxicity.

Trials 147

Trials Therapies DNA Small Molecule 147

Drug Discovery World

AUGUST 28, 2024

The European Commission has granted marketing authorisation for antibody-drug conjugate (ADC) Padcev (enfortumab vedotin) in combination with PD-1 inhibitor Keytruda (pembrolizumab) for urothelial cancer. I look forward to seeing the treatment combination implemented as a first-line regimen in the clinical setting.”

Treatment 130

Treatment Clinical Trials Trials FDA 130

Drug Discovery World

SEPTEMBER 4, 2024

The first patient has been treated in a Phase II trial of EVO756 in adults with chronic inducible urticaria (CIndU). “As we continue to execute on our clinical development plans for EVO756, we are commencing this Phase II trial in 15 study sites across the United States.

Clinical Trials 130

Clinical Trials Trials Small Molecule Clinical Development 130

Drug Discovery World

JULY 24, 2024

The trial was carried out at the Queen Elizabeth Hospital, Birmingham, UK, by the University of Birmingham’s Drugs, Devices, Diagnostics and Biomarkers (D3B) team. I am very grateful for the engaging participation by the patients in especially difficult circumstances due to the onset of the pandemic during the trial period.”

Trials 130

Trials Disease Hospitals Drugs 130

Drug Discovery World

SEPTEMBER 11, 2024

A gene therapy developed by University of Florida scientists restored useful vision to most patients with rare condition Leber congenital amaurosis type I (LCA1) in a small trial. The trial also tested the safety profile of the treatment. Side effects were largely limited to minor surgical complications.

Therapies 147

Therapies Trials Clinical Trials Laboratories 147

Drug Discovery World

OCTOBER 11, 2023

Collaborators Boehringer Ingelheim and CDR-Life have commenced a Phase I evaluation of BI 771716, their antibody fragment-based treatment developed to preserve the vision of people with geographic atrophy (GA).

Clinical Trials 130

Clinical Trials Treatment Trials FDA Approval 130

Drug Discovery World

OCTOBER 27, 2023

The US Food and Drug Administration (FDA) has granted clearance for Endogena’s Investigational New Drug (IND) application for EA 2351, a potential treatment for geographic atrophy (GA). The post FDA gives green light for AMD treatment trials appeared first on Drug Discovery World (DDW).

FDA 130

FDA Treatment Trials Therapies 130

Drug Discovery World

JANUARY 8, 2024

Milan-based Newron Pharmaceuticals has reported “exceptional” one-year results from study 014/15 into evenamide as an add-on to antipsychotics for the management of treatment-resistant schizophrenia (TRS). These results should lead to expediting the conduct of a placebo-controlled international trial to replicate these results.”

Treatment 147

Treatment Drugs Laboratories Pharmaceuticals 147

Quanticate

SEPTEMBER 13, 2024

With the implementation of technology rapidly increasing, stricter regulatory standards, and growing demand for innovative treatments, the trends within the industry continue to evolve, impacting the future of clinical trials both positively and negatively.

Clinical Trials 95

Clinical Trials Trials Drug Development Treatment 95

Drug Discovery World

APRIL 14, 2023

Researchers from the University of Oxford have reported findings from a Phase II clinical trial investigating the efficacy of an investigational treatment against long Covid fatigue. Clinical trial details On average, patients had symptoms of fatigue for about 18 months prior to entering the study.

Treatment 130

Treatment Trials Clinical Trials Pharmaceutical Companies 130

Drug Discovery World

AUGUST 8, 2024

The first cohort of participants has been dosed in a Phase I trial MTX-474, a human IgG1 antibody designed to neutralise EphrinB2 signalling to treat fibrosis. I look forward to completion of the Phase I studies and future planned Phase II trials in systemic sclerosis and IPF, respectively.”

Treatment 147

Treatment Pharmacokinetics Trials Disease 147

Drug Discovery World

NOVEMBER 30, 2023

Biotechnology company Certa Therapeutics has revealed positive Phase II clinical trial data for FT011 in patients with scleroderma. Treatment with FT011 for 12 weeks resulted in a clinically meaningful improvement in 60% of patients treated with FT011 400mg and 20% of patients in the FT011 200mg group compared with 10% in the placebo group.

Drug Trials 147

Drug Trials Trials Clinical Trials Drugs 147

Drug Discovery World

APRIL 8, 2024

Scientists from Gwangju Institute of Science and Technology in Korea have discovered compound 11c, a potentially ground-breaking oral treatment for metabolic dysfunction-associated steatohepatitis. It is progressing to Phase I clinical trials with JD Bioscience.

Disease 130

Disease Treatment Pharmacokinetics Clinical Trials 130

Drug Discovery World

OCTOBER 6, 2022

A new Alzheimer’s disease (AD) treatment has been shown to reduce clinical decline in mild cognitive impairment (MCI) due to AD and mild AD with confirmed presence of amyloid pathology in the brain. . protofibril antibody lecanemab met the primary endpoint and all key secondary endpoints in the global Phase III Clarity AD clinical trial. .

Trials 130

Trials Treatment Clinical Trials Disease 130

Drug Discovery World

AUGUST 14, 2024

The US Food and Drug Administration (FDA) has approved a Phase II clinical trial for Biosyngen’s BRG01, an EBV-specific CAR-T cell therapy. This marks the first cell therapy to enter Phase lI trials in both the US and China for the treatment of relapsed/metastatic EBV-positive nasopharyngeal carcinoma.

Therapies 130

Therapies Trials Clinical Trials FDA 130

Drug Discovery World

SEPTEMBER 4, 2024

The European Commission has granted orphan medicinal product designation (OMPD) to Cereno Scientific’s lead drug candidate CS1 for pulmonary arterial hypertension (PAH). The EU OMPD complements the orphan drug designation (ODD) granted by the US FDA in 2020, enhancing the protection and value of CS1 in these major markets.

Drugs 264

Drugs FDA Marketing Treatment 264

Drug Discovery World

JULY 5, 2024

Amgen has reported positive topline results from its randomised, double-blind, multicentre, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of its treatment for Immunoglobulin G4-related disease (IgG4-RD).

Treatment 147

Treatment Medical Schools Trials Clinical Trials 147

Drug Discovery World

DECEMBER 16, 2022

Jannsen has revealed clinical trial results for its pipeline of products to treat multiple myeloma and leukaemia. . Along with positive Phase II trial data for talquetamab , the company presented promising findings on the long-term results of daratumumab in newly diagnosed, transplant-ineligible multiple myeloma patients. .

Trials 130

Trials Treatment Clinical Trials Therapies 130

Drug Discovery World

JUNE 25, 2024

A new study demonstrates that AI-powered digital twin solutions can potentially replace the standard-of-care (SOC) control arm of a clinical trial. Phesi created a digital twin for chronic graft versus host disease (cGvHD) in the primary treatment setting.

Clinical Trials 147

Clinical Trials Trials Hospitals Clinical Research 147

Drug Discovery World

JUNE 21, 2024

Allogene Therapeutics and Foresight Diagnostics have announced the initiation of a Phase II trial evaluating the use of cemacabtagene ansegedleucel (cema-cel) as part of the first line treatment regimen for newly diagnosed large B-cell lymphoma (LBCL) patients who are likely to relapse.

Trials 147

Trials Compliance Clinical Trials Doctors 147

Drug Discovery World

SEPTEMBER 15, 2022

A new combination therapy could represent a significant advancement in the treatment of metastatic colorectal cancer. Findings from the SUNLIGHT trial have revealed that the combination of trifluridine/tipiracil plus bevacizumab showed a statistically significant improvement in overall survival compared to trifluridine/tipiracil alone.

Trials 130

Trials Treatment Clinical Trials Hospitals 130

Drug Discovery World

NOVEMBER 25, 2022

A potential new drug to improve the long-term outcomes for heart attack patients will be trialled in the UK under a new agreement. . The Birmingham trial will be run by the Institute of Cardiovascular Sciences and University Hospitals Birmingham NHS Foundation Trust.

Trials 130

Trials Treatment Hospitals Laboratories 130

Drug Discovery World

AUGUST 27, 2024

Skye Bioscience has started screening patients for a Phase II clinical trial (CBeyond) of its novel peripheral CB1 inhibitor, nimacimab, a negative allosteric modulating antibody. Assessing psychiatric effects of CB1 inhibition The clinical trial will enrol 120 patients across four treatment groups.

Trials 130

Trials Small Molecule Clinical Trials Treatment 130

Drug Discovery World

MAY 8, 2024

Calliditas Therapeutics has announced data from the proof-of-concept Phase II trial evaluating setanaxib, its lead NOX enzyme inhibitor, in combination with pembrolizumab, in patients with squamous cell carcinoma of the head and neck (SCCHN).

Trials 173

Trials Clinical Trials Treatment Disease 173

Drug Discovery World

NOVEMBER 8, 2023

Deepika Khedekar , Associate Centralized Clinical Lead at IQVIA, explains how artificial intelligence could make clinical trials more accurate, accessible and standardised. Tapping into the capabilities of AI One reason AI may accelerate clinical trials is its ability to rapidly process and analyse vast amounts of data.

Clinical Trials 182

Clinical Trials Trials Disease Medical Schools 182

Drug Discovery World

JUNE 3, 2024

Thousands of cancer patients in England are set to gain fast-tracked access to trials of mRNA personalised cancer vaccines following the launch of an NHS trial ‘matchmaking’ service to help find new life-saving treatments.

Vaccine 147

Vaccine Trials Clinical Trials Hospitals 147

Drug Discovery World

AUGUST 6, 2024

The Phase I/II AFFINITY DUCHENNE trial assessed RGX-202 in patients with Duchenne ages 1 to 11 years old. This data continues to build on the totality of evidence supporting the potential for RGX-202 to be a differentiated, best-in-class treatment for Duchenne.” Initiation of the pivotal trial is expected in the fourth quarter of 2024.

Therapies 147

Therapies Trials Treatment Clinical Trials 147

Drug Discovery World

JUNE 9, 2023

Bellerophon Therapeutics has announced it will close its Phase III study of INOpulse, its treatment for fibrotic Interstitial Lung Disease (fILD), after the trail failed to meet its primary endpoint. The post Phase III pulmonary fibrosis drug trial fails appeared first on Drug Discovery World (DDW). minutes per day.

Drug Trials 130

Drug Trials Trials Clinical Trials Drugs 130

Drug Discovery World

JULY 14, 2022

Biotech company Actigen has moved closer to clinical trials for rare disease treatment for Hunter syndrome, following a pre-Investigational New Drug (IND) meeting with the US Food and Drug Administration (FDA). ? . Hunter syndrome . Official comments .

Clinical Trials 130

Clinical Trials Treatment Trials Disease 130

Drug Discovery World

APRIL 16, 2024

Axoltis Pharma has received authorisation from ANSM, the French agency for the safety of health products, to launch the SEALS study for Amyotrophic Lateral Sclerosis (ALS). This Phase II clinical trial of drug candidate NX210c in patients with ALS is the first to target the integrity of the blood brain barrier (BBB).

Clinical Trials 130

Clinical Trials Trials Drugs Pharmacokinetics 130

Drug Discovery World

MAY 17, 2024

Deepika Khedekar , Associate Centralized Clinical Trial Lead at IQVIA Inc, looks at the challenges of utilising artificial intelligence (AI) in oncology clinical research. MIT research 4 tells us a hard truth: about 95% of these trials fall short, leaving behind a trail of broken hopes for cancer patients each year.

Trials 147

Trials Clinical Trials Treatment Research 147

Drug Discovery World

JULY 12, 2024

Scientists at the University of Oxford in the UK have launched a new clinical trial to test a vaccine to protect against “devastating” Marburg virus. This is the first-in-human trial of the ChAdOx1 Marburg vaccine, which has been developed and manufactured by researchers at the University of Oxford.

Virus 147

Virus Vaccine Trials Clinical Trials 147