Drug Discovery World

JANUARY 31, 2024

Breye is developing novel, oral ophthalmology drugs fordiabetic retinopathy (DR) or age-related macular degeneration (AMD). The burden on patients with diabetic retinopathy is significant and those who experience vision loss and blindness face threats to their physical and mental health and overall quality of life.

Treatment 130

Treatment Clinical Trials Pharmacokinetics Trials 130

Drug Discovery World

DECEMBER 4, 2023

QN-01 is currently being evaluated in the US by the FDA’s Center for Drug Evaluation and Research (CDER) and in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA). The results from Qnovia’s first in-human study demonstrate a superior pharmacokinetic profile compared to existing NRTs. “We

Therapies 130

Therapies Treatment Pharmacokinetics Clinical Development 130

ASPET

JUNE 10, 2024

Radiation therapy, a standard treatment option for many cancer patients, induces DNA double strand breaks (DSBs), leading to cell death. Efficacy of radiosensitizers for brain tumors may be influenced by a lack of effective drug delivery across the blood-brain barrier (BBB).

Pharmacokinetics 40

Pharmacokinetics Pharmacogenetics Treatment DNA 40

Drug Discovery World

AUGUST 23, 2022

The European Medicines Agency (EMA) has granted a Marketing Authorisation Application (MAA) for a combination treatment targeting adults with acute myeloid leukaemia (AML) who are not candidates for standard induction chemotherapy. . References . ? 1: Geissler K, Koristek Z, Bernal del Castillo T, et al. Abstract P573.

Treatment 130

Treatment Pharmacokinetics Clinical Trials DNA 130

ASPET

FEBRUARY 26, 2024

Panobinostat is a potent pan-HDAC inhibitor that has been tested in multiple studies for the treatment of brain tumors. There have been contrasting views surrounding its efficacy for the treatment of tumors in the CNS following systemic administration when examined in different models or species.

Metabolic Stability 40

Metabolic Stability Pharmacokinetics Pharmacogenetics Treatment 40

Drug Target Review

DECEMBER 12, 2023

We use hydrophilic linkers, which prevent ADC aggregation and generate highly stable ADCs, in combination with a unique attachment site on the antibody to create ADCs that retain pharmacokinetic properties similar to the original unconjugated antibody. This helps to maximize the targeted payload delivery to tumor cells.

Treatment 114

Treatment Engineering Pharmacokinetics Doctors 114

Drug Discovery World

AUGUST 19, 2024

The study will assess the safety, pharmacokinetic and pharmacodynamic profiles and anti-tumour activity for CV6-168 in the treatment of patients with advanced metastatic solid tumours refractory to standard treatment, including colon, gastric, breast, ovarian, lung, and other solid tumours.

Trials 147

Trials Therapies DNA Small Molecule 147

Molecular Design

MARCH 31, 2019

Drug design is a multi-objective endeavor. Other objectives such as controllability of exposure are much less easily defined and this means that drug design is indirect. Some objectives such as maximization of affinity against target(s) and minimization of affinity against anti-targets are easily defined.

Pharmacokinetics 52

Pharmacokinetics Treatment Drugs 52

ASPET

JULY 15, 2024

Mathematical modeling combining pharmacokinetics (PK) and toxicodynamics (TD) is a promising approach for optimizing dosing strategies and reducing toxicity. The PK-TD model successfully predicted the time-course profiles of hematological responses in rats following monotherapy and XELOX combination treatment.

Pharmacokinetics 40

Pharmacokinetics Therapies Drugs Treatment 40

Drug Discovery World

FEBRUARY 2, 2024

Sunday 4 February is World Cancer Day, an international awareness day led by the Union for International Cancer Control (UICC), so the round-up this week will focus on oncology, including the UK approval of a rare blood cancer drug and a novel production process for CAR-T therapies.

Pharmacokinetics 130

Pharmacokinetics Drugs International Clinical Trials 130

Drug Discovery World

AUGUST 13, 2024

Animal models (AMs) have generally been seen as useful for drug development and biomedical research for many years. They are assumed to closely mimic human disease progression and act as a good testing ground for toxicology studies and pharmacokinetics 1. Drugs developed in animals often fail in human studies. Possibly not.

Drug Development 162

Drug Development Animal Testing Regulations Drugs 162

Drug Discovery World

SEPTEMBER 6, 2022

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Avacta Group’s chemotherapy drug, AVA6000, for the treatment of soft tissue sarcoma. . This designation qualifies the developer of the drug for certain incentives, like seven years of market exclusivity upon drug approval from the FDA.

FDA 130

FDA Pharmacokinetics Drugs Clinical Trials 130

Drug Discovery World

OCTOBER 25, 2023

Iksuda Therapeutics has dosed the first patient in a Phase I trial of antibody drug conjugate (ADC) IKS014 in patients with advanced solid tumours that express HER2. We hope that this trial of IKS014 could lead to improved treatment options for patients with HER2+ solid tumours.”

Pharmacokinetics 130

Pharmacokinetics Trials Drugs Clinical Trials 130

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 post Early trial data supports neurodegenerative disease-modifying drug appeared first on Drug Discovery World (DDW).

Disease 130

Disease Trials Small Molecule Pharmacokinetics 130

Drug Discovery World

JANUARY 9, 2023

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation for iOnctura’s IOA-244, which is in development for solid and hematologic malignancies including uveal melanoma. . Part A of the study investigated the safety and pharmacokinetics of continuous daily dosing of IOA-244 at 10, 20, 40 and 80mg. .

FDA 130

FDA Drugs Pharmacokinetics Trials 130

Drug Discovery World

MARCH 10, 2023

The approval is in patients with locally advanced or metastatic urothelial cancer (la/mUC) who have received prior treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy. “In The post Astellas’ urothelial cancer drug approved in China appeared first on Drug Discovery World (DDW). 100,000 cases, or 235,393 cases.

Pharmacokinetics 130

Pharmacokinetics Drugs Licensing Licensing 130

Drug Discovery World

JULY 25, 2023

Justin Hay , Senior Director, Amy Cheung Senior Director of Integrated Drug Development, and Patrick Loebs Director, at Certara, examine recent changes in paediatric guidelines and how they affect drug development projects. In addition to describing the ethical framework (eg.

Drug Development 130

Drug Development Clinical Pharmacology Pharmacokinetics Drugs 130

Drug Discovery World

FEBRUARY 14, 2024

The post Data shows restored motor function in mouse models of Parkinson’s disease appeared first on Drug Discovery World (DDW). The post Data shows restored motor function in mouse models of Parkinson’s disease appeared first on Drug Discovery World (DDW).

Disease 147

Disease Clinical Trials Pharmacokinetics Trials 147

Drug Discovery World

SEPTEMBER 1, 2022

These sequence-defined, recombinant antibodies are suitable for developing highly selective and sensitive pharmacokinetic (PK) and anti-drug antibody (ADA) assays for evolocumab and its biosimilars. Evolocumab is a monoclonal antibody used for the treatment of hyperlipidemia, or elevated levels of cholesterol and other lipoproteins.

Drug Development 130

Drug Development Biosimilars Pharmacokinetics Drugs 130

Drug Discovery World

JANUARY 23, 2023

Researchers have discovered a clinical drug that sensitises glioblastoma (GBM) cells to radiotherapy and could replace the current standard of care. As an FDA-approved oral drug, the side-effects of cladribine are quite manageable and it has been well evaluated for pharmacokinetics. “As

FDA Approval 130

FDA Approval FDA Drugs Pharmacokinetics 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 Pharmacokinetics Drugs 130

Drug Discovery World

JUNE 29, 2023

DDW’s Diana Spencer provides an overview of the latest innovations in drug discovery for mental health. To mark the occasion, this article summarises the most recent news about the ways drug discovery is improving wellbeing and mental health through innovative new treatments and therapies.

Drugs 130

Drugs Pharmacokinetics Trials FDA 130

Drug Discovery World

OCTOBER 30, 2023

Kura Oncology’s FIT-001 Phase I dose-escalation trial of KO-2806, a farnesyl transferase inhibitor (FTI) for the treatment of advanced solid tumours, has commenced with the dosing of the first patient. The post Farnesyl transferase inhibitor for solid tumours enters trials appeared first on Drug Discovery World (DDW).

Trials 130

Trials Pharmacokinetics Therapies Treatment 130

Drug Discovery World

APRIL 10, 2023

Beckley Psytech has initiated a Phase IIa study investigating its lead candidate, BPL-003, as a potential treatment for alcohol use disorder (AUD). Beckley Psytech’s Phase IIa study, taking place at King’s College Hospital in London, will explore the safety, efficacy and pharmacokinetics of BPL-003 in patients diagnosed with AUD.

Pharmacokinetics 130

Pharmacokinetics FDA Approval Hospitals Treatment 130

Drug Discovery World

JUNE 27, 2023

Together, the three institutions, in collaboration with Therapeutic Innovation Australia (TIA), will guide early-stage projects through the process of identifying drug candidates with potential commercial value. MedChem Australia will fill this gap.

Drugs 130

Drugs Medical Chemistry Pharmacokinetics Science 130

Drug Discovery World

APRIL 5, 2023

A new, oral, first-in-class experimental cancer drug has shown potent activity against cancer cells and caused shrinkage of hard-to-treat human ovarian tumours grown in mice, a new study shows. It also supports the drug’s potential to treat other cancers. We hope that our drug goes on to show effectiveness in clinical trials.”

Clinical Trials 130

Clinical Trials Pharmacokinetics Drugs DNA 130

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.

Disease 130

Disease Pharmacokinetics Treatment Hospitals 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.

Small Molecule 130

Small Molecule Trials Pharmacokinetics Treatment 130

Drug Discovery World

NOVEMBER 15, 2022

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. . Initial results show a dose-proportional pharmacokinetic (PK) profile and good tolerability with no serious adverse events reported. .

Pharmacokinetics 130

Pharmacokinetics Treatment Drugs Trials 130

Drug Discovery World

NOVEMBER 10, 2023

Dense aggregates of immune cells, including CD8 positive granzyme B positive cytotoxic T cells, dendritic cells, and B cells, were observed in PDAC tissue after CAN-2409 treatment, confirming activation of a robust antitumoral immune response.

Pharmacokinetics 130

Pharmacokinetics Clinical Trials Immune Response Treatment 130

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. The post First PROTAC degrader for neurodegenerative disease enters trials appeared first on Drug Discovery World (DDW).

Trials 130

Trials Disease Clinical Trials Pharmacokinetics 130

Drug Target Review

JULY 12, 2023

Molecular-level biochemical assays like transcriptomics, genomics and proteomics have emerged as valuable tools for identifying potential targets in cancer treatment through deep cyclic inhibition (DCI). This platform can help identify and optimise pharmacologic properties of new drugs.

Biochemical Assays 98

Biochemical Assays Treatment Bioinformatics Disease 98

Drug Discovery World

JANUARY 10, 2024

Adding AIO-001, a potentially best-in-class medicine targeting the TSLP pathway, could expand the reach of our current respiratory biologics portfolio, including to the 40% of severe asthma patients with low T2 inflammation where treatment options are still needed.”

Pharmacokinetics 130

Pharmacokinetics Licensing Licensing Clinical Development 130

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. The potential synergistic effect in suppressing T2 inflammation is believed to be the basis of its superior efficacy in the treatment of T2 inflammatory disorders.

Trials 130

Trials Pharmacokinetics Clinical Trials Clinical Development 130

Drug Discovery World

AUGUST 14, 2023

Research partners in the UK are progressing their orally available small molecule cancer immunotherapy drug into clinical development as a treatment for advanced solid tumours. We hope that this EP4-targeting approach will deliver a promising route to improving treatment options for patients with a broad range of cancers.”

Trials 130

Trials Small Molecule Pharmacokinetics Clinical Trials 130

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.

Small Molecule 130

Small Molecule Trials Pharmacokinetics Regulations 130

Drug Discovery World

DECEMBER 21, 2022

Biopharmaceutical company Rezolute has initiated a Phase II proof-of-concept study for RZ402, a plasma kallikrein inhibitor (PKI) being developed as an oral therapy for the treatment of diabetic macular oedema (DMO). . The post Oral therapy for diabetic macular oedema progresses to Phase II appeared first on Drug Discovery World (DDW).

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Therapies Pharmacokinetics Clinical Development Treatment 130