Drugs and Trials - Drug Discovery Digest

Antibody-drug conjugate for solid tumours enters Phase I trials

Drug Discovery World

AUGUST 9, 2024

The first patient has been dosed in a Phase I clinical trial of AGX101, a novel TM4SF1-directed antibody-drug conjugate being developed for the treatment of solid cancers. AGX101 with its novel and differentiated mechanisms of action represents a first-in-class drug with potential to address high unmet medical needs.

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Microbiome drug to be tested in IBS clinical trial

Drug Discovery World

APRIL 4, 2024

EnteroBiotix, a Glasgow, UK based biotechnology company, has dosed the first patient in a clinical trial designed to evaluate EBX-102-02 for the treatment of irritable bowel syndrome (IBS). The trial will be delivered in partnership with the Functional Gut Clinic, a leading IBS diagnosis and treatment centre.

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Recombinant polyclonal drug trial for HBV gets FDA green light

Drug Discovery World

AUGUST 7, 2024

The US Food and Drug Administration (FDA) has cleared GigaGen’s application to initiate a Phase I trial of its polyclonal drug for the treatment of hepatitis B virus (HBV) infection, GIGA-2339. Currently there is no cure, as existing drugs can halt viral replication but only minimally reduce the levels of viral protein.

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Potentially game-changing schizophrenia drug enters Phase I trials

Drug Discovery World

DECEMBER 7, 2023

A potential schizophrenia treatment, discovered at Vanderbilt University in Tennessee in the US, has been cleared by the US Food and Drug Administration for use in Phase I clinical trials. The post Potentially game-changing schizophrenia drug enters Phase I trials appeared first on Drug Discovery World (DDW).

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management.

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Phase II brain metastases trial advances after futility analysis

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.

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‘Encouraging’ trial results for potential disease-modifying ALS drug

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.”

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New podcast: How to utilise clinical trials in drug discovery

Drug Discovery World

JUNE 25, 2024

This is the latest episode of the free DDW narrated podcast, titled “How to utilise clinical trials in drug discovery” which covers three articles written for Volume 24 – Issue 1, Winter 2022/2023 of DDW. and Choosing the right site solution for clinical trials.

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Clinical trial to repurpose HIV drugs to treat brain tumours

Drug Discovery World

JUNE 24, 2024

Drugs developed to treat HIV and AIDS are being trialled for the first time in patients with multiple brain tumours. The RETREAT clinical trial, led by Professor Oliver Hanemann and funded by the Children’s Tumour Foundation, will expand on research which showed the repurposed drugs reduced tumour growth and survival in the tumours.

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How to utilise clinical trials in drug discovery

Drug Discovery World

JUNE 25, 2024

This is the latest episode of the free DDW narrated podcast, titled “How to utilise clinical trials in drug discovery” which covers three articles written for Volume 24 – Issue 1, Winter 2022/2023 of DDW. and Choosing the right site solution for clinical trials.

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Clinical trial investigates oral MRGPRX2 antagonist in urticaria

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.

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AI-discovered ALS drug trial uses unique remote monitoring

Drug Discovery World

JANUARY 11, 2024

VRG50635 is a small molecule PIKfyve inhibitor and is reportedly one of the first drugs to enter clinical trials that was entirely discovered and developed using an AI-enabled platform. ” The post AI-discovered ALS drug trial uses unique remote monitoring appeared first on Drug Discovery World (DDW). .”

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Investigational therapy for advanced cancers enters trials

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.

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FDA clears genetically engineered TIL therapy for solid tumour trials

Drug Discovery World

SEPTEMBER 3, 2024

Grit Biotechnology has received investigational new drug (IND) approval from the US Food and Drug Administration (FDA) for its genetically engineered tumour-infiltrating lymphocyte (TIL) product GT201. The company raised over $60 million in a Series B financing round in September 2023 to support development of this programme.

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Patients achieve 19% weight loss in obesity drug trial

Drug Discovery World

JULY 4, 2023

“Given the prevalence of obesity and its many disease-related complications, there is a dire need for treatments that can help treat the disease of obesity effectively,” said Carel le Roux, Professor at University College in Dublin, Ireland, and Principal Investigator of the trial.

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Drug candidate for apathy enters Phase I trials

Drug Discovery World

MAY 30, 2024

Swedish company IRLAB Therapeutics has initiated a Phase I study of IRL757, its drug candidate for apathy – a condition associated with Parkinson’s disease and other CNS diseases. The Michael J Fox Foundation (MJFF) has awarded a grant of more than SEK 20 million ($2 million) to conduct this first Phase I clinical trial of IRL757.

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How can you ensure a confident transition to human trials?

Drug Discovery World

AUGUST 1, 2024

Download the whitepaper to learn more about: The importance of selecting appropriate starting doses in clinical trials. Download the whitepaper to learn more about: The importance of selecting appropriate starting doses in clinical trials. The post How can you ensure a confident transition to human trials?

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Monoclonal antibody CB1 inhibitor for obesity enters Phase II trials

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.

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Free clinical trial health check to bring drugs to market faster

Drug Discovery World

OCTOBER 20, 2023

A new free service will offer insights in under ten days to sponsors conducting clinical trials, identifying potential ‘zombie trials’ and providing actionable recommendations for failing trials. The Health Check and Trial Rescue Service is an initiative of data software and services company Phesi.

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ML could facilitate increased adoption of adaptive clinical trials

Drug Discovery World

JUNE 21, 2024

A new machine learning (ML) software platform has been launched to facilitate wider adoption of advanced and adaptive clinical trials. Novel Response Adaptive Randomization (RAR) capabilities that support multi-interims in a trial while maintaining interactivity and accuracy at the highest standards.

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The in vivo tool enabling a confident transition to Phase I trials

Drug Discovery World

AUGUST 1, 2024

This paper discusses the challenges drug developers face when transitioning from preclinical discovery to clinical trials and proposes expanding the drug development toolbox with humanised mouse models. Download the latest whitepaper to learn more about: The importance of selecting appropriate starting doses in clinical trials.

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World’s first engineered B cell therapy enters human trials

Drug Discovery World

DECEMBER 19, 2023

The first patient has been dosed with an engineered B cell investigational therapy in a Phase I trial in Mucopolysaccharidosis type I (MPS I). Developer Immusoft has received FDA Orphan Drug Designation and Rare Pediatric Disease Designation for the therapy, designated ISP-001, in this indication.

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Scleroderma drug trial shows up to 60% improvement

Drug Discovery World

NOVEMBER 30, 2023

Biotechnology company Certa Therapeutics has revealed positive Phase II clinical trial data for FT011 in patients with scleroderma. The US Food and Drug Administration (FDA) recently granted Orphan Drug Designation for FT011 for the treatment of systemic sclerosis (scleroderma).

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Positive Phase I/II trial data for Duchenne gene therapy

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. Initiation of the pivotal trial is expected in the fourth quarter of 2024. In patients aged 5.8

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Drug candidate for ALS patients authorised for Phase II clinical trial

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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CAR-T therapy for nasopharyngeal cancer enters Phase II trials

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.

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Successful clinical trial for re-engineered Covid vaccine

Drug Discovery World

NOVEMBER 24, 2023

Project leader, Associate Professor Keith Chappell, said the preliminary clinical trial results were an ‘exciting reward’ for the team’s continued dedication and the community’s widespread support for the project. “We The Clamp2 trial group showed a 2.5-fold fold boost in neutralising ‘titres’ and it was 2.1 in the Novavax group.

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First-in-human vaccine trial for deadly Marburg virus

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.

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NHS England launches country-wide cancer vaccine trials

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.

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New Drug Tames Stress Incontinence in Clinical Trial

Drugs.com

JULY 15, 2024

MONDAY, July 15, 2024 -- An experimental drug appears to help women deal with stress incontinence, clinical trial data show.The drug, for now dubbed TAS-303, reduced the frequency of leaks related to stress incontinence by about 58%, compared with.

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Decoding diseases: The AI renaissance in clinical trials

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.

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Clinical trial will assess novel approach to cystic fibrosis

Drug Discovery World

JULY 24, 2024

Enterprise Therapeutics announced it has dosed the first person with cystic fibrosis (pwCF) in its Phase IIa trial of ETD001. The Phase IIa trial aims to deliver clinical proof-of-concept and to assess the safety profile of ETD001 in the 10% of pwCF with the highest unmet medical need.

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AI digital twins could replace control arm in clinical trials

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. We have demonstrated that digital twins offer real potential to replace standard-of-care comparator arms to streamline the implementation of clinical trials and dramatically reduce patient burden.”

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AI and machine learning: A new era for clinical trials

Drug Discovery World

MAY 8, 2024

Fiona Maini , Senior Director Global Compliance & Strategy, at Medidata looks at the rise of artificial intelligence (AI) and machine learning (ML) within life sciences and the applications for the technology in clinical trials.

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Early trial data supports neurodegenerative disease-modifying drug

Drug Discovery World

MARCH 15, 2024

In addition to Allyx’s continued clinical development of ALX-001 in Alzheimer’s disease, the company has announced an expansion into Parkinson’s disease clinical research with the opening of an Investigational New Drug Application with the US Food and Drug Administration (FDA).

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Phase III pulmonary fibrosis drug trial fails

Drug Discovery World

JUNE 9, 2023

The REBUILD clinical trial was designed as a randomised, double-blind, placebo-controlled Phase III study evaluating the safety and efficacy of INOpulse for the treatment of patients with fILD. The post Phase III pulmonary fibrosis drug trial fails appeared first on Drug Discovery World (DDW).

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This week in drug discovery (2-6 September)

Drug Discovery World

SEPTEMBER 6, 2024

With the release of clinical study results that led some media titles to ask if semaglutide could be a ‘fountain of youth’, this week our news highlights focus on clinical trials at a variety of different stages. Is this drug the answer to cannabis addiction?

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From data to cure: The journey of AI in cancer trials

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.

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Phase II trial investigates allogeneic CAR-T for large B-cell lymphoma

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.

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Positive results of Phase II head and neck cancer trial

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).

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EU orphan designation for pulmonary arterial hypertension drug

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.

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First patient dosed in ulcerative colitis drug trial

Drug Discovery World

MARCH 29, 2023

A Phase I clinical trial has begun evaluating Direct Biologics’ ExoFlo for the treatment of patients with medically refractory ulcerative colitis (UC). The primary objective of the trial is to evaluate the safety of intravenous ExoFlo.

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Gene therapy trial starts in early-onset dementia

Drug Discovery World

JULY 5, 2024

AviadoBio has launched its Phase I/II ASPIRE-FTD clinical trial at the Ohio State University in the US. Diana Spencer, Senior Digital Content Editor, DDW The post Gene therapy trial starts in early-onset dementia appeared first on Drug Discovery World (DDW).

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This week in drug discovery (26-30 August)

Drug Discovery World

AUGUST 30, 2024

With the launch of an international clinical trial investigating BioNTech’s mRNA lung cancer vaccine announced this week, our news highlights focus on clinical trials, including studies of a monoclonal antibody and small molecule GLP-1 agonist for obesity, and a muscarinic M4 selective agonist for schizophrenia.

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Antibody-drug conjugate for solid tumours enters Phase I trials

Microbiome drug to be tested in IBS clinical trial

Trending Sources

Recombinant polyclonal drug trial for HBV gets FDA green light

Potentially game-changing schizophrenia drug enters Phase I trials

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Phase II brain metastases trial advances after futility analysis

‘Encouraging’ trial results for potential disease-modifying ALS drug

New podcast: How to utilise clinical trials in drug discovery

Clinical trial to repurpose HIV drugs to treat brain tumours

How to utilise clinical trials in drug discovery

Clinical trial investigates oral MRGPRX2 antagonist in urticaria

AI-discovered ALS drug trial uses unique remote monitoring

Investigational therapy for advanced cancers enters trials

FDA clears genetically engineered TIL therapy for solid tumour trials

Patients achieve 19% weight loss in obesity drug trial

Drug candidate for apathy enters Phase I trials

How can you ensure a confident transition to human trials?

Monoclonal antibody CB1 inhibitor for obesity enters Phase II trials

Free clinical trial health check to bring drugs to market faster

ML could facilitate increased adoption of adaptive clinical trials

The in vivo tool enabling a confident transition to Phase I trials

World’s first engineered B cell therapy enters human trials

Scleroderma drug trial shows up to 60% improvement

Positive Phase I/II trial data for Duchenne gene therapy

Drug candidate for ALS patients authorised for Phase II clinical trial

CAR-T therapy for nasopharyngeal cancer enters Phase II trials

Successful clinical trial for re-engineered Covid vaccine

First-in-human vaccine trial for deadly Marburg virus

NHS England launches country-wide cancer vaccine trials

New Drug Tames Stress Incontinence in Clinical Trial

Decoding diseases: The AI renaissance in clinical trials

Clinical trial will assess novel approach to cystic fibrosis

AI digital twins could replace control arm in clinical trials

AI and machine learning: A new era for clinical trials

Early trial data supports neurodegenerative disease-modifying drug

Phase III pulmonary fibrosis drug trial fails

This week in drug discovery (2-6 September)

From data to cure: The journey of AI in cancer trials

Phase II trial investigates allogeneic CAR-T for large B-cell lymphoma

Positive results of Phase II head and neck cancer trial

EU orphan designation for pulmonary arterial hypertension drug

First patient dosed in ulcerative colitis drug trial

Gene therapy trial starts in early-onset dementia

This week in drug discovery (26-30 August)

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