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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Drug Discovery World

JUNE 24, 2024

Scientists at the Brain Tumour Research Centre of Excellence at the University of Plymouth are conducting a clinical trial to see whether using anti-retroviral medications, ritonavir and lopinavir, could help people with Neurofibromatosis 2 (NF2).

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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

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

JULY 25, 2023

In participants with MDD, the trial will also assess rapid onset of antidepressant effect on the day of dosing, using the Montgomery-Asberg Depression Rating Scale and evaluate the incremental benefit of a second dose of CYB003 when administered in week three.

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Drug Discovery World

JUNE 23, 2023

PTC518 treatment was also demonstrated to be well tolerated, with no treatment-related serious adverse events, no reports of peripheral neuropathy or dose-limiting toxicities. The post Positive interim data from Huntington’s disease trial appeared first on Drug Discovery World (DDW).

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Drug Discovery World

MARCH 13, 2024

Johnson & Johnson has announced the first data from FRONTIER 2, the long-term extension of the Phase IIb FRONTIER 1 clinical trial evaluating JNJ-2113, the first and only investigational targeted oral peptide designed to block the IL-23 receptor. Across JNJ-2113 treatment groups, 58.6% at 16 weeks and 76.2% at 16 weeks and 76.2%

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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

NOVEMBER 1, 2023

However, it was associated with higher rates of grade ≥3 cytokine release syndrome and neurological events. Datopotamab deruxtecan, Daiichi Sankyo and AstraZeneca The companies shared results from multiple trials of their TROP2 directed DXd antibody drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd). Median PFS was 13.8

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Drug Discovery World

MARCH 15, 2024

All doses were well-tolerated and there were no serious adverse events. The post Early trial data supports neurodegenerative disease-modifying drug appeared first on Drug Discovery World (DDW).

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Drug Discovery World

DECEMBER 1, 2022

Based on Nakhoda and Olszanski, 2022 (Addressing Recent Failures in Immuno-Oncology Trials to Guide Novel Immunotherapeutic Treatment Strategies), lack of an optimal biomarker is one of the main challenges to clinical trial success. Director, Application Development, LevitasBio will present the event. Camila Egidio.

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Drug Discovery World

SEPTEMBER 8, 2023

The first quadruplex-edited, allogeneic CAR-T cell therapy candidate has entered clinical trials in the US. The first patient has been treated with Beam Therapeutics’ BEAM-201 as part of a Phase I/II clinical study for the treatment of relapsed/refractory T-cell acute lymphoblastic leukaemia/T-cell lymphoblastic lymphoma (T-ALL/T-LL). “As

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Drug Discovery World

APRIL 16, 2023

Patients with treatment-naïve resectable non-small cell lung cancer (NSCLC) who received neoadjuvant durvalumab (Imfinzi) plus chemotherapy and adjuvant durvalumab monotherapy had improved event-free survival (EFS) and pathological complete response (pCR) compared with those who received neoadjuvant chemotherapy alone. Overall, 77.6%

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Drug Discovery World

AUGUST 22, 2023

Bloom Science has announced positive topline data from a Phase I clinical trial of BL-001 , a potential first-in-class therapeutic the company is developing for Dravet syndrome and amyotrophic lateral sclerosis (ALS). BL-001 shows promise as a novel treatment option that can change lives.

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Drug Discovery World

DECEMBER 23, 2022

A study by Ellipses Pharma, a global drug development company focused on accelerating the development of new oncology treatments, has presented preliminary data from the first in human Phase I/II trial of EP0042, a dual FLT-3 an Aurora kinase inhibitor, in patients with acute myeloid leukaemia (AML). . The data . Official comments

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Drug Discovery World

MAY 15, 2024

Despite affecting such a large subset of diabetic patients, treatment options are limited to repeated, invasive intravitreal injections to the eye. Diabetic retinopathy – current treatments The journey for patients with DR is one of increasing severity and loss of vision. In 2019 there were >14.2

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Drug Discovery World

SEPTEMBER 16, 2024

The authors found that T cell malignancies represented a small minority of adverse events at just 1.5%. The European Medicines Agency (EMA) has also reduced daily hospital safety monitoring for patients following treatment with CAR-T cell therapies Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel).

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Drug Discovery World

APRIL 10, 2023

RESP-X, Infex Therapeutics’ anti-virulence therapy to treat Pseudomonas aeruginosa (Pa) infections in non-cystic fibrosis bronchiectasis (NCFB) patients, has shown a promising interim safety and tolerability profile in its ongoing first-in-human Phase I clinical trial.

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Drug Discovery World

JUNE 15, 2023

A Phase I clinical trial testing a CAR-T cell therapy treatment in children with acute myeloid leukaemia (AML) has been paused due to a patient’s death. The PLAT-08 clinical trial is a Phase I study of 2seventy bio’s cell therapy SC-DARIC33 in patients with AML.

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Drug Discovery World

MARCH 15, 2023

The primary endpoint has been achieved in a Phase II trial of AP30663, a first-in-class SK ion channel inhibitor for conversion of atrial fibrillation (AF) to normal sinus rhythm. Acesion Pharma enrolled 63 patients with a current episode of AF in the trial and tested two intravenous doses of AP30663, 3 and 5mg/kg, compared to placebo.

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Drug Discovery World

MAY 8, 2024

The ORCA-V1 trial was led by Achieve Life Sciences, and co-led by an investigator from Massachusetts General Hospital. “No In their previous clinical trial, the research team found that cytisinicline helped people to quit smoking traditional cigarettes. “The For cytisinicline treatment compared to placebo, 31.8% versus 15.1%

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Drug Discovery World

NOVEMBER 9, 2023

The positive human qEEG biomarker results with apimostinel are consistent with prior biomarker observations with zelquistinel, Gate’s lead programme, which is currently being developed as a rapid-acting, once weekly, oral treatment for major depressive disorder (MDD). “We

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Advarra

OCTOBER 1, 2024

Managing clinical trial budgets efficiently is necessary for the success and sustainability of clinical research sites. Effective budget management not only ensures trials are financially viable but also maximizes return on investment (ROI). the impact and value of the data produced).

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PPD

AUGUST 7, 2024

Clinical trials are the backbone of medical research, enabling the development of new treatments and therapies that can improve patient outcomes. However, conducting successful clinical trials requires efficient communication and coordination among various stakeholders. This is where contact center services play a vital role.

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Drug Discovery World

JULY 19, 2023

The primary endpoint of iADRS measures cognition and activities of daily living such as managing finances, driving, engaging in hobbies, and conversing about current events. 52% of participants completed their course of treatment by one year and 72% completed by 18 months as a result of achieving plaque clearance. in the placebo group.

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Drug Discovery World

FEBRUARY 9, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation to AstraZeneca for Imfinzi (durvalumab) in combination with gemcitabine and cisplatin in Great Britain for use as a first-line treatment of adults with locally advanced, unresectable or metastatic biliary tract cancer (BTC). versus 11.5%).

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Drug Discovery World

APRIL 18, 2024

First results from the EAGLE-1 Phase III trial for gepotidacin show that two oral doses of the antibiotic displayed superior success rates (92.6%) when compared to the combination treatment of ceftriaxone and oral azithromycin, which saw a 91.2% The imperative for innovative treatments has never been clearer. success rate.

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Drug Discovery World

JULY 12, 2023

Following four weeks of treatment, there is a three-month safety follow-up period. Primary and secondary safety and efficacy endpoints include the rate of adverse and serious adverse events and the improvement in diuretic response (measured as a six-hour urine sodium output) from baseline through the end of the treatment period.

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Drug Discovery World

AUGUST 23, 2024

A new study indicates that anti-obesity drug semaglutide helps prevent cardiac events among overweight people who have cardiovascular disease, even if they also have heart failure. whose hearts did not pump blood around the body properly) by a clinician at the start of the trial.

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Drug Discovery World

AUGUST 2, 2024

This translates to a placebo-adjusted weight loss from baseline of 7.4%, 9.2%, 11.3%, and 13.10% in the treatment groups. In a Phase I trial of an oral tablet formulation of VK2735, up to 3.3% The company plans to initiate a Phase II trial with the oral formulation of VK2735 in obesity later this year.

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PPD

JUNE 24, 2024

In the realm of vaccine development, mega trials — studies enrolling 5,000 subjects or more — have been instrumental in the fight against many pathogens, including influenza, rotavirus, malaria, RSV and most recently in the rapid development of vaccines against COVID-19.

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Drug Discovery World

MAY 10, 2024

291 patients were randomised to treatment either with evenamide or placebo as add-on to their current antipsychotic therapy. There was no difference in the incidence of CNS, psychiatric, gastrointestinal or other adverse events between evenamide and placebo. points, compared to 7.6

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Drug Discovery World

FEBRUARY 21, 2024

In October 2023, pharmaceutical company NKGen Biotech released data from its Phase I clinical trial on the use of its investigational natural killer therapy, SNK01, to treat patients with Alzheimer’s disease. RA: What are the clinical benefits of using the patient’s own cells as a treatment? What will be the goals from this study?

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Drug Discovery World

JUNE 28, 2024

A new Phase II trial, REGENERATE-PD, will study AB-1005, an adeno-associated virus 2 (AAV2) glial cell line-derived neurotrophic factor (GDNF) gene therapy for the treatment of moderate-stage Parkinson’s disease. The trial will include an estimated 87 subjects with study sites located in the US, UK and Europe.

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Conversations in Drug Development Trends

JULY 8, 2024

By: Lisle Kingery, PhD, Therapeutic Strategy Lead, Neuroscience With depression rates at an all-time high and limited new treatments available, depression clinical trials are more important than ever. Treatment Treatment can take various forms, including therapy, medication, a combination of both, or a clinical trial.

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Drug Discovery World

NOVEMBER 30, 2023

The reports were received from clinical trials and postmarketing adverse event (AE) data sources. The FDA has cautioned that patients and clinical trial participants receiving treatment with these products should be monitored life-long for new malignancies.

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Drug Discovery World

SEPTEMBER 2, 2024

In all three arms, the treatment regimens were observed to have a favourable safety profile and to be generally well tolerated, with only 12 of the 175 patients (four patients in each arm) discontinuing treatment due to adverse events.

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