Drug Discovery World

MARCH 8, 2024

Biopharmaceutical company Innovent Biologics has launched the first-in-human (FIH) Phase I clinical trial of IBI3002, a novel bispecific antibody targeting Interleukin 4 receptor α (IL-4Rα) and thymic stromal lymphopoietin (TSLP).

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Drug Discovery World

DECEMBER 12, 2023

During the trial, EXN407 met all safety and pharmacokinetic parameters and displayed encouraging signals of biological activity. Patients in the Phase Ib/IIa trial were treated twice a day for three months, with either EXN407 or placebo. EXN407 is a small molecule inhibitor of splice factor kinase SRPK1.

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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. The study, taking place in Australia, is designed to assess the safety, tolerability, pharmacokinetics, and target engagement of MTX-474 in healthy participants.

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Drug Discovery World

JUNE 26, 2024

Spinogenix has initiated a Phase II trial to evaluate SPG302 for the treatment of adult participants with mild-to-moderate Alzheimer’s disease (AD), following approval for the trail in Australia. The study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of SPG302 in adult AD participants.

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Drug Discovery World

OCTOBER 10, 2023

Rejuvenate Biomed, a clinical-stage company advancing therapeutics to delay the onset of age-related diseases, has completed a six-week clinical proof-of-mechanism study with lead candidate RJx-01 for the treatment of sarcopenia.

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Drug Discovery World

SEPTEMBER 13, 2024

QL Biopharm, a clinical stage biopharmaceutical company developing biologic drugs for the treatment of metabolic diseases, has shared Phase Ic clinical data for its lead drug candidate ZT002. The primary endpoints were safety and tolerability, and secondary endpoints were pharmacokinetics, pharmacodynamics, and immunogenicity.

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Drug Discovery World

JANUARY 31, 2024

Breye Therapeutics, a clinical-stage biopharmaceutical company developing novel oral therapies for retinal vascular diseases within ophthalmology, has started a Phase Ib/IIa clinical trial to investigate danegaptide, following oral administration, in patients suffering from diabetic macular oedema (DMO).

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Drug Discovery World

NOVEMBER 3, 2023

Two patients with pancreatic cancer and renal cell carcinoma, respectively, exhibited prolonged (> six months) stable disease. We’re pleased to share these first clinical data from our clinical trial of NDI-101150. NDI-101150 demonstrated an acceptable safety profile below 200mg/day, the identified non-tolerated dose.

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Drug Discovery World

AUGUST 13, 2024

They are assumed to closely mimic human disease progression and act as a good testing ground for toxicology studies and pharmacokinetics 1. A lack of translatability The most obvious argument against the continued blanket requirement for AMs is that they are not very translational for many disease areas.

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Drug Discovery World

NOVEMBER 10, 2023

CAN-2409 in non-metastatic pancreatic cancer Candel Therapeutics reported on initial positive interim data from its Phase II clinical trial of CAN-2409 that showed notable improvements in patients with borderline resectable pancreatic ductal adenorcarcinoma (PDAC). The estimated overall survival rate was 71.4%

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Drug Discovery World

FEBRUARY 2, 2024

Phase I trial for first-in-class bispecific antibody for cancer Onward Therapeutics has announced the Phase I clinical trial of OT-A201, a first-in-class bispecific antibody targeting two immune checkpoints is in progress. The findings were published in the New England Journal of Medicine.

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Drug Discovery World

MAY 24, 2023

Moderna has reported encouraging interim data from its Phase I/II trial of mRNA-3927, an mRNA therapy for rare metabolic disorder propionic acidemia (PA). Currently, there are no effective therapies for PA that target the underlying root cause of the disease.

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Drug Discovery World

SEPTEMBER 6, 2022

Avacta has an ongoing Phase I clinical trial to assess the safety and pharmacokinetics of AVA6000, which has potential as a treatment for patients with a range of cancer types. Despite the successful advancement of localised therapies, such as surgery and radiotherapy, these tumours can recur, often with metastatic disease. .

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Drug Discovery World

MAY 31, 2023

Immuno-oncology company Aulos Bioscience has revealed interim results from an ongoing Phase I/II trial of monoclonal antibody AU-007 in solid tumours. The Phase I/II trial AU-007 is the first computationally designed human monoclonal antibody in a human clinical trial.

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Drug Discovery World

DECEMBER 14, 2023

PROTAC ER degrader vepdegestrant Arvinas and Pfizer presented interim data from a Phase Ib trial of vepdegestrant, a novel oral PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, in combination with palbociclib (Ibrance). The data revealed an overall response rate of 42% and median progression-free survival of 11.1

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Drug Discovery World

JULY 25, 2023

These guidelines facilitate open communication between regulators and researchers, enabling the industry to adapt and conduct more robust and efficient paediatric clinical studies, while avoiding unnecessary trials. This article will summarise these five guidelines, with a specific focus on modelling and simulation when it is discussed.

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Drug Discovery World

JANUARY 9, 2023

Uveal melanoma is a disease in which cancer originates in the tissues of the eye, causing symptoms such as blurred vision or a dark spot on the iris. . A PI3Kδ inhibitor, IOA-244 ( roginolisib) is being investigated in the DIONE-01 trial, a two-part, first-in-human Phase I study.

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Drug Discovery World

DECEMBER 4, 2023

Smoking continues to be the leading cause of preventable death and disease, leading to almost eight million direct and indirect deaths annually. The results from Qnovia’s first in-human study demonstrate a superior pharmacokinetic profile compared to existing NRTs.

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The Pharma Data

OCTOBER 15, 2020

Vertex Pharmaceuticals has decided to give up on its experimental VX-814, a small molecule drug for the rare genetic disease Alpha-1 antitrypsin deficiency (AATD), canning the drug’s development after seeing lackluster results from an early phase 2 trial. James Miessler. Source link.

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Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

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Drug Discovery World

JULY 20, 2023

What are benefits of drug repurposing and why do clinical drug trials so often fail? There will probably already be some clinical data for the drug in question and this can save both time and money, as the company can secure regulatory approval without lengthy and costly early-stage clinical trials.

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PPD

JULY 29, 2024

AI also has the potential to incorporate real-world data (RWD) obtained from electronic health records (EHRs), medical claims or other data sources to inform the design and optimization strategy of clinical trials. A high-risk participant can be even excluded from the study based on the severity of the adverse event.

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Drug Target Review

NOVEMBER 1, 2023

2 Implication of ATX in a large range of human diseases have been highlighted by both fundamental research and clinical trials. 1-5 Implication of ATX in a large range of human diseases have been highlighted by both fundamental research and clinical trials. Mediators of Inflammation. 2017;2017:1–15.

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Drug Discovery World

DECEMBER 21, 2022

The Phase II study is a multicentre, randomised, double-masked, placebo-controlled, parallel-arm study to evaluate the safety, efficacy, and pharmacokinetics of RZ402 as monotherapy over a 12-week treatment period in participants with DME who are naïve to or have received limited anti-VEGF injections. .

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The Pharma Data

MARCH 22, 2021

Basel, 22 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the decision to discontinue dosing in the Phase III GENERATION HD1 study of tominersen in manifest Huntington’s disease (HD). About tominersen and the clinical trials. About Huntington’s disease. said Levi Garraway, M.D.,

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Drug Discovery World

SEPTEMBER 26, 2022

It’s also why pharmaceutical companies will look to acquire smaller biotechs and drug discovery companies, because a lot of the legwork into finding a suitable molecule for a disease has already been done. . However, challenges remain.

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Drug Discovery World

MARCH 10, 2023

“In China, there were nearly 86,000 new cases of bladder cancer in 2020, and we are working with the NMPA to seek approval for enfortumab vedotin for patients with advanced stage disease,” said Ahsan Arozullah, Senior Vice President and Head of Development Therapeutic Areas, Astellas.

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The Pharma Data

NOVEMBER 9, 2021

– More than 30 Abstracts Across HDV, HCV, HBV, NASH and PSC Reflect Gilead’s Ongoing Commitment to Addressing Challenges Facing People Living With Liver Diseases –. About Gilead Sciences in Liver Disease. For more than 20 years, Gilead has sought to address some of the biggest challenges in liver disease. Gilead Lores,Inc.

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Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

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Drug Discovery World

APRIL 3, 2024

Obtaining these results will allow us to reach a key milestone of the project: approval from the health authorities to test CM-352 in a Phase I clinical trial. Our initial focus will be on the US FDA.

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Drug Discovery World

JUNE 12, 2023

Those are the beginning of additional manufacturing, scale of chemistry pharmacokinetics, pharmacology assays, development bioanalytical assays, and then moving forward toxicology work to start the initial clinical trials. It gives the history of the disease and it’s pretty amazing.

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Drug Discovery World

NOVEMBER 29, 2022

This ranges from understanding disease processes and identifying possible drug targets, to organising testing, rolling out clinical trials, negotiating complex regulations and licensing and finally, treating patients. These are: Fundamentals of science: Understanding how the body works and what goes wrong in disease.

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Alta Sciences

OCTOBER 30, 2023

Discover the considerations and assessments necessary for performing preclinical research for ophthalmic therapies in this new eBook, that covers everything you need to know, from species selection and routes of administration, to preparing for first-in-human trials. Read it now. The Altascientist : Issue No. Read or listen now. Watch it now.

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The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company. BOSTON, Jan.

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Drug Discovery World

FEBRUARY 20, 2023

Breast cancer retained its position as the most-studied disease area in clinical trials in 2022, according to a recent report by analytics company Phesi. Here, we take a look at the top four disease areas and some of the key developments in 2022. The candidate demonstrated 64.7%

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Alta Sciences

JANUARY 31, 2024

Pharmacokinetics, Pharmacodynamics and Toxicokinetics Demystified pmjackson Wed, 01/31/2024 - 14:55 Understanding the effects of a drug, and how it interacts with the body, and vice versa, is critical to ensure it is safe for human use. This is where pharmacokinetic (PK), pharmacodynamic (PD) , and toxicokinetic (TK) analyses step in.

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The Pharma Data

NOVEMBER 18, 2020

This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels. SEFA’ stands for Structurally Engineered Fatty Acid, i.e. chemically engineered fatty acids, to generate compounds with differentiated physiochemical properties.

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