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Disease Events Pharmacokinetics 
Drug Discovery World
SEPTEMBER 3, 2024
Join DDW and Lonza for this free event ‘ Building advanced cell models for toxicity testing ’. The event will take place on 19 September at 3pm GMT / 4pm CET / 10am EST / 7am PST. The post Free event: Next generation predictive in vitro ADMET solutions appeared first on Drug Discovery World (DDW).
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Drug Discovery World
MARCH 15, 2024
Biotechnology company Allyx Therapeutics has reported positive Phase Ib clinical data for its lead compound, ALX-001, a first-in-class, synapse-targeted, disease-modifying oral therapy in development for neurodegenerative diseases. All doses were well-tolerated and there were no serious adverse events.
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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
SEPTEMBER 17, 2024
Join DDW and Lonza for this free event ‘ Building advanced cell models for toxicity testing ’. The event will take place on 19 September at 3pm GMT / 4pm CET / 10am EST / 7am PST.
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Drug Discovery World
SEPTEMBER 10, 2024
Join DDW and Lonza for this free event ‘ Building advanced cell models for toxicity testing ’. The event will take place on 19 September at 3pm GMT / 4pm CET / 10am EST / 7am PST.
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Drug Discovery World
AUGUST 27, 2024
Join DDW and Lonza for this free event ‘ Building advanced cell models for toxicity testing ’. The event will take place on 19 September at 3pm GMT / 4pm CET / 10am EST / 7am PST.
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Drug Discovery World
AUGUST 20, 2024
Join DDW and Lonza for this free event ‘ Building advanced cell models for toxicity testing ’. The event will take place on 19 September at 3pm GMT / 4pm CET / 10am EST / 7am PST.
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Drug Discovery World
DECEMBER 12, 2023
During the trial, EXN407 met all safety and pharmacokinetic parameters and displayed encouraging signals of biological activity. Exonate is building on its expertise in alternative splicing to develop medicines to treat end organ disease caused by poor diabetic control.
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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
MAY 24, 2023
The ongoing global Phase I/II clinical trial is a multicentre, open-label study designed to assess the safety, pharmacodynamics, and pharmacokinetics of mRNA-3927 in participants aged one year and older with genetically confirmed PA. Currently, there are no effective therapies for PA that target the underlying root cause of the disease.
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Drug Discovery World
JANUARY 9, 2023
Uveal melanoma is a disease in which cancer originates in the tissues of the eye, causing symptoms such as blurred vision or a dark spot on the iris. . Part A of the study investigated the safety and pharmacokinetics of continuous daily dosing of IOA-244 at 10, 20, 40 and 80mg. .
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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
OCTOBER 13, 2022
DDW’s Megan Thomas comments on the presentations, posters and booths at the event and the new addition of the ELRIG Tech Theatre, supported by DDW. . When it comes to metrics of success for an event such as Drug Discovery 2022, the numbers speak for themselves. Over the two days at ExCel, 1554 delegates attended the event.
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Drug Discovery World
JUNE 12, 2023
Those are the beginning of additional manufacturing, scale of chemistry pharmacokinetics, pharmacology assays, development bioanalytical assays, and then moving forward toxicology work to start the initial clinical trials. It gives the history of the disease and it’s pretty amazing.
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Drug Discovery World
APRIL 3, 2024
We will now complete efficacy, toxicity, pharmacodynamic and pharmacokinetic studies in several preclinical models required by regulatory agencies. Obtaining these results will allow us to reach a key milestone of the project: approval from the health authorities to test CM-352 in a Phase I clinical trial. “Our
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PPD
JULY 29, 2024
AI can also predict the likelihood of a serious adverse event before administering the investigational product at an individual level, allowing patients to be categorized by their risk profile. A high-risk participant can be even excluded from the study based on the severity of the adverse event.
The Pharma Data
OCTOBER 14, 2021
For all other classes evaluated in the analysis, including the broad range of MS therapies offered by Biogen, the antibody response to vaccination is consistent with the response of patients not being treated with an MS disease-modifying therapy (DMT). Cleveland Clinic, and a paid consultant for Biogen. Source link: [link].
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Drug Discovery World
JULY 20, 2023
Drug repurposing in neurological diseases The next speaker was Robert Pitceathly, Honorary Consultant at The National Hospital for Neurology and Neurosurgery, UCL Queen Square Institute of Neurology, London, UK. However, despite a known safety profile and mechanism of action, the failure rate of 30% is still high.
The Pharma Data
NOVEMBER 6, 2020
The Advisory Committee also voted 0 yes, 7 no and 4 uncertain on the question, “Does Study 103 (PRIME) provide supportive evidence of the effectiveness of aducanumab for the treatment of Alzheimer’s disease?”, Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer’s disease.
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Drug Target Review
SEPTEMBER 25, 2024
At TOLREMO, we have developed a proprietary modular phenotypic screening platform that leverages transcriptional reprogramming events associated with non-genetic resistance to deliver new chemical scaffolds and identify novel resistance regulators. Available from: [link] 8.Boni Journal of Clinical Oncology [Internet].
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The Pharma Data
MARCH 13, 2021
HAE is unpredictable, debilitating and potentially life-threatening, and recognition of the disease remains low in Japan, meaning there are significant challenges relating to diagnosis and access to effective therapies,” said Naoyoshi Hirota, General Manager, Takeda Development Center, Japan. Takeda in Hereditary Angioedema. Interactions.
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The Pharma Data
MAY 5, 2021
It also provided supporting pharmacokinetic data demonstrating the opioid antagonist’s safety and efficacy. . Farxiga use expanded for reducing risks in patients with chronic kidney disease. A total of 197 patients in the study arm had at least one of the composite endpoint events, compared with 312 patients in the placebo arm.
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Drug Target Review
JUNE 12, 2023
What are the preclinical characteristics of ISM6331, including its efficacy, safety profile, and drug metabolism and pharmacokinetics (DMPK) properties? ISM6331 is a Pan-TEAD inhibitor with novel scaffold with good IP space, discovered by Chemistry42.
Drug Discovery World
SEPTEMBER 9, 2024
Vesper Bio has completed a Phase I study for its lead candidate, VES001, a potentially disease-modifying treatment for frontotemporal dementia patients with mutations in the progranulin gene (FTD(GRN)). Frontotemporal dementia is the most common cause of dementia in people under the age of 60.
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The Pharma Data
JANUARY 3, 2021
Nasdaq: INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced that the U.S. . BOSTON, Jan. 04, 2021 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. About Inozyme Pharma.
The Pharma Data
MARCH 9, 2022
Sanofi and Swedish Orphan Biovitrum AB (publ) (Sobi ® ) (STO:SOBI) today announced positive topline results from the pivotal XTEND-1 Phase 3 study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa (BIVV001) in previously treated patients ?12 12 years of age with severe hemophilia A.
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The Pharma Data
JANUARY 3, 2021
Preclinical data from our laboratory have shown that the nasal administration of anti-CD3 stimulates Tregs that can suppress inflammation and ameliorate inflammatory diseases. Dr. Kimble Matos, the lead coordinating physician of the study, commented: “The observations made during the Clinical study did not show any adverse events.”.
The Pharma Data
SEPTEMBER 26, 2021
With MS, finding the proper treatment option is the maximum amount about managing the clinical aspects of the disease because it is about how treatment fits into a person’s life,” said Simon Faissner, M.D., In clinical trials, the foremost common adverse events related to TECFIDERA were flushing, abdominal pain, diarrhea and nausea.
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The Pharma Data
AUGUST 19, 2021
1 Disease response was evaluated using overall response rate (ORR), per Response Evaluation Criteria in Solid Tumors Version 1.1* (RECIST v1.1) 1 Disease response was evaluated using overall response rate (ORR), per Response Evaluation Criteria in Solid Tumors Version 1.1* (RECIST v1.1) Interstitial Lung Disease/Pneumonitis 7.
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The Pharma Data
AUGUST 29, 2020
Seven of ten patients discontinued eculizumab and remained on LNP023 as monotherapy, retaining hemoglobin (Hb) levels with no changes in biomarkers of disease activity and with no signs or symptoms of breakthrough hemolysis . Peffault de Latour. The most common AEs reported were headache, insomnia, rhinitis, and rhinorrhea.
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The Pharma Data
DECEMBER 9, 2020
The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days.
The Pharma Data
DECEMBER 28, 2020
NASH, which is a severe form of non-alcoholic fatty liver disease affects approximately 17 million people in the U.S. The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. and is a leading cause of liver transplantation.
The Pharma Data
APRIL 14, 2021
Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together and bamlanivimab alone. Some of these events required hospitalization. It is not known if these events were related to bamlanivimab use or were due to progression of COVID-19. Adverse Events.
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The Pharma Data
JULY 22, 2021
The prospective, phase 3, open-label, international multicenter study included 23 patients with severe von Willebrand disease (VWD). No new risks were identified, with no serious adverse events related to rVWF reported. About von Willebrand Disease (VWD). The sABR was reduced by 91.5% population. population. About Hemophilia.
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The Pharma Data
DECEMBER 13, 2020
AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and additional chronic and rare metabolic diseases. NASH Investor Event Information. A replay of the event will be available on Poxel’s website following the presentation.
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The Pharma Data
JULY 27, 2021
The acquisition includes Teneobio’s proprietary bispecific and multispecific antibody technologies, which will enable significant acceleration and efficiency in the discovery and development of new molecules that have the potential to treat a wide range of important diseases across Amgen’s core therapeutic areas. Reese, M.D.,
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The Pharma Data
MAY 4, 2021
Lilly will donate both baricitinib (4 mg tablet) as well as bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together – providing options to treat COVID-19 patients at different stages of the disease. ” The allocation of therapies will be based on the disease burden and hospitalization rates in each country.
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The Pharma Data
APRIL 11, 2021
In this cohort, the most common treatment-emergent adverse events of any grade (?20%) No patients in this cohort discontinued treatment due to treatment-related adverse events. 50 kg, respectively), taken twice daily until disease progression or unacceptable toxicity. 3 hemorrhagic events occurred in 2.3%
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The Pharma Data
JULY 11, 2021
years with TAKHYZRO is Consistent with Initial Period of Treatment, Building on Growing Body of Evidence on the Long-term Safety and Efficacy Final Patient Subgroup Analysis Suggests Reductions of HAE Attacks Across Range of Patient Demographics and Disease Characteristics with TAKHZYRO. Analysis of Safety and Efficacy for up to 2.5
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DrugBank
SEPTEMBER 19, 2024
However, translating a promising therapeutic candidate into a successful oral medication presents pharmacokinetic and pharmacodynamic challenges. Pharmacokinetics of Oral Drugs Orally administered drugs undergo a series of biochemical processes that can affect their bioavailability and their clinical efficacy.
Drug Discovery World
NOVEMBER 17, 2022
Subcutaneously administered RLYB116 was observed to be generally well-tolerated at the 100mg dose, with mild or moderate adverse events and no drug-related serious adverse events reported. . The post Positive Phase I results for rare disease inhibitor appeared first on Drug Discovery World (DDW).
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The Pharma Data
APRIL 16, 2021
Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together. Some of these events required hospitalization. It is not known if these events were related to bamlanivimab use or were due to progression of COVID-19. Adverse Events.
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The Pharma Data
NOVEMBER 11, 2020
The Dorothy Crowfoot Hodgkin Campus will boast the co-location of in vitro pharmacology and protein sciences, structural biology, drug metabolism and pharmacokinetics, computational, synthetic, and medicinal chemistry, formulation sciences, development chemistry and API manufacture. 0)40.56081-255, gabriele.hansen@evotec.com.
The Pharma Data
SEPTEMBER 19, 2020
While we have made great progress in the treatment of many forms of breast cancer, TNBC remains an aggressive and difficult-to-treat disease,” said Levi Garraway, M.D., 2.80] in the PD-L1 positive population, based on 21% of patients with an event; updated HR=1.12 [95% CI: 0.76-1.65]), pCR was observed in 57.6% (95% CI: 49.7–65.2)
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