Drug Discovery World

OCTOBER 2, 2023

The EC decision is based on the results from the Phase III ASCERTAIN clinical trial investigating the pharmacokinetic exposure equivalence of the novel oral fixed-dose combination versus intravenous (IV) decitabine in AML patients.

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Drug Discovery World

SEPTEMBER 28, 2022

Measuring the pharmacokinetics of monoclonal antibodies. Learn about the critical role analytical tools and equipment have in helping to advance drug discovery research in this DDW ebook sponsored by Sartorius. This ebook covers: Opinions on the major trends in lab analytics. Best practices in cell line development. Access the eBook here.

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Drug Discovery World

OCTOBER 30, 2023

FIT-001 is a first-in-human, multicentre, open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of KO-2806 when administered as monotherapy and in combination with targeted therapies.

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Drug Discovery World

DECEMBER 5, 2023

Download the guide to learn more about:  How JAX’s HuPK™ Humanised FcRn Platform offers a validated and cost-effective solution for assessing the in vivo  preclinical pharmacokinetics and stability of Fc-based biologics and therapeutics carried by albumin.   JAX’s portfolio of FcRn humanised mouse models. 

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Drug Discovery World

MAY 11, 2023

They are chemically synthesisable, featuring a low molecular weight and tunable pharmacokinetics, with a large surface-area for molecular interactions that allows protein-protein interactions to be targeted. The two companies will jointly use Bicycle’s peptide technology to develop bicyclic peptides for several oncology targets.

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Drug Discovery World

MARCH 15, 2024

The study concluded that EXN407 met all pharmacokinetic and safety parameters, as well as showing encouraging signs of biological activity. The Phase IIb study is planned to initiate in 2024, following the successful completion of the company’s Phase Ib/IIa trial for EXN407.

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Drug Discovery World

APRIL 8, 2024

Beyond its therapeutic potential and pharmacokinetic attributes, including over 60% oral bioavailability, compound 11c exhibits hepatocyte and plasma stability, minimal cytotoxicity, and low cytochrome P450 inhibition. This action, targeting both inflammation and fibrosis, is a promising step forward in treating MASH.”

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Drug Discovery World

DECEMBER 5, 2023

Study design templates, expected results, and troubleshooting tips for the most common applications of JAX’s HuPK™ Platform.  

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Drug Discovery World

APRIL 10, 2023

Phase I data has already shown BPL-003 to be well-tolerated with consistent dose delivery, a reproducible and dose-linear pharmacokinetic profile, and a reliable induction of profound psychedelic experiences.

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Drug Discovery World

DECEMBER 22, 2023

The trial met all pharmacokinetic objectives, so the company plans to progress the candidate into further clinical development and will meet with the US Food and Drug Administration (FDA) at a Pre-IND meeting in the first half of 2024.

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Drug Patent Watch

OCTOBER 30, 2023

Over the past two decades, Bayer Pharma has developed an in silico absorption, distribution, metabolism, and excretion (ADMET) platform with the aim of generating models for various pharmacokinetic and physicochemical… The post Advancements in In Silico ADMET Modeling: A 20-Year Journey of Machine Learning in Drug Discovery at Bayer Pharma appeared (..)

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Drug Discovery World

NOVEMBER 10, 2023

SNS-101, VISTA-blocking monoclonal antibody Sensei Biotherapeutics presented clinical dose escalation data from a Phase I/II study of its SNS-101 monotherapy, which showed well tolerated safety profile, potentially best-in-class pharmacokinetics, and encouraging cytokine release profile across multiple dose cohorts.

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Drug Discovery World

FEBRUARY 27, 2024

The Phase I clinical trial of ARV-102 will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARV-102, including the evaluation of LRRK2 degradation and exploratory LRRK2 pathway biomarkers. In non-human primates, orally administered ARV-102 has been shown to reach deep-brain regions and degrade LRRK2 by nearly 90%.

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Drug Discovery World

MARCH 8, 2024

The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IBI3002 in healthy participants and participants with mild to moderate asthma. IL-4 receptors mediate the IL-4 signalling (both type 1 and type 2) and the IL-13 signalling (type 2).

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Drug Discovery World

AUGUST 23, 2022

The MAA is supported by results from a Phase III clinical trial investigating the pharmacokinetic (PK) exposure equivalence of the novel oral fixed-dose combination versus IV decitabine. Orally administered decitabine and cedazuridine showed an exposure equivalence to a standard five-day regimen of IV decitabine. References . ?

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Treatment Pharmacokinetics Clinical Trials DNA 130

Drug Discovery World

FEBRUARY 14, 2024

“We believe the data showing complete restoration of motor function in a therapeutic model are remarkable and further support the potential of GT-02287 to slow or stop the progression of Parkinson’s disease, a disease for which only symptomatic treatments are available to patients at this time,” said Matthias Alder, Gain Therapeutics’ Chief Executive (..)

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Drug Discovery World

NOVEMBER 3, 2023

The Phase I/II trial is a multicentre, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of NDI-101150 given as monotherapy or in combination with pembrolizumab in adults with advanced or metastatic solid tumours.

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Pharmacokinetics Clinical Trials Trials Disease 130

Drug Discovery World

FEBRUARY 13, 2024

It has demonstrated efficacy in in vitro and in vivo models of fibrosis, as well as favourable safety and pharmacokinetic profiles in Phase I clinical studies. AM1476 is a selective peripheral-acting 5-HT2B receptor small molecule antagonist that can be delivered orally.

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Drug Discovery World

JULY 25, 2023

The section on ‘clinical pharmacology considerations’ covers the physiological differences in paediatric patients that can be attributed to pharmacokinetics and pharmacodynamics of the compound/drug of interest. Increasing application of pediatric physiologically based pharmacokinetic models across academic and industry organizations.

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SCIENMAG: Medicine & Health

NOVEMBER 1, 2023

A small clinical trial with a pharmacokinetic sub-study, led by a world-renowned pharmacologist at the University of Houston, has demonstrated the promising effectiveness of the drug Riluzole for improving functionality in people with acute spinal cord injuries (SCI) if the drug is taken within 12 hours post-injury.

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Drug Discovery World

SEPTEMBER 28, 2022

Measuring the pharmacokinetics of monoclonal antibodies. . The latest DDW eBook reveals the critical role analytical tools and equipment have in helping to advance drug discovery research. It is sponsored by Sartorius. . This ebook covers: . Opinions on the major trends in lab analytics. . Best practices in cell line development. .

Pharmacokinetics 130

Pharmacokinetics Drugs Research 130

Chemical Biology and Drug Design

MARCH 7, 2024

The physicochemical, pharmacokinetic, drug-like, and drug-score features of all synthesized compounds were assessed using the online Swiss ADME and Protein Plus software. AutoDock 4.2 was used for their in silico screening against AMPA (-amino-3-hydroxy-5-methylisoxazole) receptor (PDB ID:3m3f). kJ/mol, respectively.

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Drug Discovery World

DECEMBER 4, 2023

The results from Qnovia’s first in-human study demonstrate a superior pharmacokinetic profile compared to existing NRTs. Existing pharmacotherapies lack the rapid onset and peak levels of nicotine delivery to effectively alleviate cravings and withdrawal symptoms during a quit attempt.

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Drug Discovery World

MARCH 15, 2024

The Phase Ib study examined the safety, tolerability and pharmacokinetics of twice-daily oral doses of ALX-001 in 32 heathy adult participants aged 50-80. The findings were presented at the AD/PD 2024 Conference in Lisbon. Study results show that ALX-001 was safe in cognitively normal older adults at all tested doses.

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Drug Discovery World

JANUARY 10, 2024

Early studies of AIO-001 have shown initial safety, tolerability, pharmacokinetics, and biological activity in healthy volunteers and asthma patients. Targeting the TSLP pathway addresses a key driver of the inflammatory response in major allergic and inflammatory diseases.

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Chemical Biology and Drug Design

JANUARY 29, 2024

In-silico ADME studies significant values of pharmacokinetic parameters and demonstrated good drug like characteristics based on Lipinski's rule of five. In addition, the QSTR study of new compounds were carried out with the help of Toxicity Estimation Software Tool (T.E.S.T). The results showed slight toxic nature of new compounds.

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Drug Discovery World

OCTOBER 25, 2023

The second, dose-expansion, phase of the study (Phase Ib) is to further evaluate the safety, pharmacokinetics / pharmacodynamics, and efficacy of IKS014 at the recommended Phase II dose. The study is designed to evaluate the safety and tolerability of increasing dose levels of IKS014 to establish a recommended Phase II dose.

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Drug Discovery World

FEBRUARY 2, 2024

The study aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumoural activity of OT-A201.

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Chemical Biology and Drug Design

MARCH 5, 2024

The potent compounds 5d , 5e , and 5f were subjected to in silico pharmacokinetic assessment by SWISS, ADME, and pkCSM. In addition to this, molecular docking studies of compounds 5d , 5e , and 5f demonstrated that these compounds had more EGFR-binding interactions.

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Drug Discovery World

JANUARY 31, 2024

Support for danegapitide’s potential With safety data derived from over 500 clinical trial participants, robust toxicology data, and strong non-clinical in vitro and in vivo efficacy results, there is strong support for danegaptide’s potential to address the clinical core ocular pathologies of vascular leakage and capillary breakdown.

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Drug Discovery World

AUGUST 10, 2023

COV-X also demonstrated a superior drug metabolism and pharmacokinetics (DMPK) profile to nirmatrelvir. In five of the six samples dosed with COV-X at 200mg/kg, viral load in the lungs was below the limit of detection. Even at doses five times lower than nirmatrelvir, COV-X provided protection from lung damage.

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Drug Discovery World

NOVEMBER 15, 2022

Initial results show a dose-proportional pharmacokinetic (PK) profile and good tolerability with no serious adverse events reported. . The drug is under development for Treatment Resistant Depression and Alcohol Use Disorder and was assessed in combination with psychological support in 44 psychedelic-naïve participants. .

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Pharmacokinetics Treatment Drugs Trials 130

Drug Discovery World

DECEMBER 12, 2023

Exonate, an mRNA therapy company focused on treatments for diabetic complications, has announced that its lead ophthalmology asset, EXN407, has achieved its prespecified endpoints in a Phase Ib/IIa study. During the trial, EXN407 met all safety and pharmacokinetic parameters and displayed encouraging signals of biological activity.

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Drug Discovery World

AUGUST 14, 2023

Cancer Research UK’s Centre for Drug Development (CDD) is sponsoring, designing and conducting the Phase I/IIa trial with three main objectives: to define the toxicity, tolerability and pharmacokinetics of HTL0039732, to identify the recommended dose for Phase II studies, and to assess its antitumour activity as a monotherapy and in combination with (..)

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Chemical Biology and Drug Design

MARCH 6, 2024

Thus, polonilignan has been identified as a new pan-cytokine and NO inhibitor, it is recommended to optimise a method for the synthesis of this small molecular weight lignan and explore its pharmacokinetic characteristics, toxicity and therapeutic effect under various chronic inflammatory disease models.

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Pharmacokinetics Regulations Production Disease 100

Drug Discovery World

OCTOBER 10, 2023

Dr Silke Huettner, Chief Medical Officer of Rejuvenate Biomed, said: “This proof-of-mechanism study has confirmed the excellent pharmacokinetics, as well as the safety and tolerability profile of RJx-01. Rejuvenate Biomed is gearing up to initiate a Phase II programme focused on RJx-01 in the treatment of sarcopenia in 2024.

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Drug Discovery World

MARCH 8, 2023

Dosing has begun in a Phase I clinical study evaluating BAT8008, an antibody-drug conjugate (ADC) that targets Trop2. Key objectives of the study are to determine the maximum tolerated dose (MTD), recommended Phase II dose (RP2D), and to evaluate the pharmacokinetics and preliminary efficacy in patients with advanced solid tumours.

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