Drug Discovery World

FEBRUARY 27, 2024

Arvinas has commenced dosing in the Phase I clinical trial of ARV-102, its first oral PROTAC (PROteolysis-TArgeting Chimera) protein degrader in development to treat neurodegenerative diseases. The post First PROTAC degrader for neurodegenerative disease enters trials appeared first on Drug Discovery World (DDW).

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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

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

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. Chief Investigator Dr Bristi Basu, University of Cambridge, and Co-Chief Investigator Dr Debashis Sarker, King’s College London, are leading the trial.

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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).

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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

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

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. . 1: Geissler K, Koristek Z, Bernal del Castillo T, et al. Abstract P573.

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

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Drug Discovery World

APRIL 12, 2023

Evecxia Therapeutics has reported favourable safety, tolerability, pharmacokinetic, and pharmacodynamic data from a Phase I trial of EVX-101 in healthy volunteers treated with escitalopram. Details of the trial In EVX-101, the 5-HTP dose is fixed at 250mg, while variable levels of carbidopa control 5-HTP plasma exposure levels.

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Drug Discovery World

JULY 25, 2023

The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics, and psychedelic effect of ascending oral doses of CYB003.

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Drug Discovery World

DECEMBER 4, 2023

“Looking ahead, we are committed to advancing QN-01 into the next stage of clinical development and will be working closely with FDA and MHRA to bring this treatment option to the millions of smokers who want to quit.” The results from Qnovia’s first in-human study demonstrate a superior pharmacokinetic profile compared to existing NRTs. “We

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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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Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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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).

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Alta Sciences

SEPTEMBER 13, 2023

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials pmjackson Wed, 09/13/2023 - 17:01 September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions.

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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. This follows positive data from Phase I clinical trials through Fosun Pharma, which is now progressing FS-1502 (IKS014) through Phase II and Phase III trials in China.

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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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The Pharma Data

AUGUST 28, 2020

Celltrion Group has announced that the Korean Ministry of Food and Drug Safety has approved the company’s Investigational New Drug application for a Phase 1 trial for their coronavirus antiviral antibody treatment candidate.

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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

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). The Phase I/II clinical trial The trial utilised a dose-escalation approach to evaluate the intravenous administration of mRNA-3927.

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Drug Discovery World

DECEMBER 14, 2023

Antibody drug conjugate MBRC-101 MBrace Therapeutics presented preclinical data demonstrating the potential of its novel antibody drug conjugate MBRC-101 for the treatment of solid tumours including hormone receptor-positive (HR+) and triple negative breast cancers. months in heavily pre-treated patients. “We

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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. The pharmaceutical industry is following the regulatory lead in terms of what regulators are perceived to want and look to trial designs where AMs do translate with some level of reliability.

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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. . The trial recently advanced to the fourth dose cohort of patients at 200mg/m2, following a positive review of the safety and tolerability data from the third cohort.

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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

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.

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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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Advarra

JUNE 20, 2023

Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community. More targeted therapies may change which patients and cancers may benefit, since a given treatment may only impact very specific biomarkers and genetic profiles.

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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

JUNE 29, 2023

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. The Phase IIa proof-of-concept trial will evaluate short-term changes in anxiety-related patient reported outcomes in approximately 50 healthy volunteers.

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Drug Discovery World

JULY 25, 2023

The pharmaceutical industry is constantly developing evidence-based treatments for children while there continue to be scientific advancements related to new modalities and disease understanding. This article will summarise these five guidelines, with a specific focus on modelling and simulation when it is discussed.

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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.

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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. .

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Drug Discovery World

APRIL 5, 2023

The drug, which is now called NXP800 and has already entered a Phase I clinical trial, was discovered by scientists at The Institute of Cancer Research, London. We hope that our drug goes on to show effectiveness in clinical trials.”

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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). How does the DCI mechanism compare to the design of other drugs for cancer treatment?

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Drug Discovery World

JANUARY 9, 2023

When the cancer metastases, which it does in approximately 50% of patients, there are limited treatment options and projected overall survival is only a year. . 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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