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Clinical Development Pharmacokinetics Therapies 
Drug Discovery World
DECEMBER 4, 2023
Qnovia has announced positive results from its first in-human study of QN-01, an inhaled smoking cessation therapy. QN-01 is designed to meet the urgent need for new safe and effective pharmacotherapies that address the shortcomings of currently available nicotine replacement therapies (NRTs).
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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). .
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Drug Discovery World
DECEMBER 14, 2023
“We are thrilled to see this level of clinical activity in such a heavily pre-treated patient population,” said John Houston, Chairperson, Chief Executive Officer and President at Arvinas. Vepdegestrant is the only PROTAC ER degrader in late-stage clinical development. The results show a 25.1%
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Drug Discovery World
DECEMBER 22, 2023
Neuroscience drug discovery company Sapient Therapeutics successfully completed Part B of the Phase I trial comparing its CBD therapy SAP021 with Epidiolex. We now look forward to the next stage of clinical development.”
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Drug Discovery World
APRIL 3, 2024
million from the Spanish Research Agency (AEI), under the call for grants for Public-Private Collaboration Projects, to accelerate the development of an innovative treatment aimed at controlling disabling and lethal haemorrhage.
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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. The findings were presented at the AD/PD 2024 Conference in Lisbon.
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Drug Discovery World
JANUARY 10, 2024
The acquisition includes Aiolos’ AIO-001, a potentially best-in-class, long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody ready to enter Phase II clinical development for asthma, with potential for additional indications.
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Drug Discovery World
JUNE 27, 2023
This gap exists between fundamental drug discovery biology programmes and the generation of defined and optimised candidate drug molecules that have the potential to attract the commercial partnerships required to support formal clinical development programmes.
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Alta Sciences
OCTOBER 30, 2023
TOP NONCLINICAL SCIENTIFIC RESOURCES eBook : Safety Assessment for Ophthalmic Products Designing preclinical studies for ocular therapies take a lot of deliberation. The Altascientist : Issue No. Read or listen now. Watch the video. Watch it now. The Altascientist : Issue No.
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Drug Target Review
JUNE 6, 2023
We are in an era of immuno-oncology (IO) revolution with many approved therapies now available to treat a broad range of cancers. For the last several years, the field has worked to unlock the potential of IO therapies for additional tumour types, and has explored options beyond checkpoint inhibitors.
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Advarra
JUNE 20, 2023
Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54 Typical clinical development timelines for anticancer drugs average an estimated 6.7
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The Pharma Data
OCTOBER 27, 2020
“Once we’re in the clinic, we will continue to add multiple programs into the clinic with no rate abatement, or speed abatement, in the next five- to 10-year horizon.” . Former Sarepta Therapeutics executive Bo Cumbo left to launch his new gene therapy company, AavantiBio, with a $107 million Series A. AavantiBio . Sirnaomics.
The Pharma Data
NOVEMBER 18, 2020
This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels. The Company’s third SEFA, 6179, is expected to enter the clinic in the first half of 2021, targeting IFALD, for which no treatment is currently available.
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The Pharma Data
DECEMBER 13, 2020
About 15 to 20% of breast cancers cases are HER2+, and antibody-based therapies targeting HER2 have significantly improved outcomes of patients with HER2+ breast cancer. Zai Labs obtained regional development and commercialization rights for the programs in mainland China, Hong Kong, Macau and Taiwan.
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The Pharma Data
APRIL 11, 2023
Bayer is advancing its oncology R&D efforts in three scientific areas that have the potential to address unmet needs in cancer patients: next-generation Immuno-Oncology, Targeted Radionuclide Therapies and Precision Molecular Oncology. Data from all three areas of scientific focus will be showcased during this year’s meeting.
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Drug Discovery World
OCTOBER 11, 2023
The secondary objective is to evaluate the pharmacokinetics of SAD and MAD dose levels to identify a maximum tolerated dose (MTD) and identify recommended doses for further clinical development. The post Allosteric therapy targets common genetic cause of Parkinson’s appeared first on Drug Discovery World (DDW).
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Sygnature Discovery
NOVEMBER 29, 2023
It was conceived, invented and developed by Professor Stephen Neidle and his team in the School of Pharmacy at University College London with the involvement of Sygnature Discovery scientists. The Phase 1a clinical trial involves a small group of patients who will be given carefully monitored doses of the drug.
The Pharma Data
NOVEMBER 8, 2020
The submission includes data from the ENLIGHTEN clinical development program in schizophrenia, and pharmacokinetic (PK) bridging data comparing ALKS 3831 and Zyprexa (olanzapine), to support an indication for schizophrenia. Celgene acquired it in 2018 from bluebird bio, who originally developed the therapy.
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Sygnature Discovery
NOVEMBER 29, 2023
It was conceived, invented and developed by Professor Stephen Neidle and his team in the School of Pharmacy at University College London with the involvement of Sygnature Discovery scientists. The Phase 1a clinical trial involves a small group of patients who will be given carefully monitored doses of the drug.
The Pharma Data
DECEMBER 9, 2020
The first trial will be conducted as a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the intravenous liposomal formulation of ibrexafungerp in healthy subjects. The study will be conducted in South Africa. For more information, visit www.scynexis.com.
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The Pharma Data
AUGUST 19, 2021
3] While MET inhibitors have recently received accelerated approval in this setting in some regions, the vast majority of patients eventually acquire resistance to these therapies, thus underscoring the need for new treatment options. [4] Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “We
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Drug Discovery World
AUGUST 14, 2024
The first subjects have been dosed in two separate Phase I clinical trials evaluating the safety, tolerability, and pharmacokinetics of Sionna Therapeutics’ SION-719 and SION-451 in healthy volunteers. The company is also developing complementary modulators with the goal of advancing differentiated combination therapies for CF.
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The Pharma Data
NOVEMBER 9, 2021
We ’re agitated to partake data from our robust clinical development programs at AASLD’s The Liver Meeting ®, including the rearmost data demonstrating the positive impacts of bulevirtide for people living with HDV.”. For more than 20 years, Gilead has sought to address some of the biggest challenges in liver disease.
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The Pharma Data
OCTOBER 25, 2020
Treatment choices are limited, and commonly used off-label therapies are not always effective or may result in prolonged, deep sedation. In addition, this indication offers synergy with the commercial infrastructure being developed to support our first New Drug Application.”. NEW HAVEN, Conn., BioXcel Therapeutics, Inc.
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The Pharma Data
JANUARY 3, 2021
The Phase 1/2 clinical trial will primarily investigate the safety and tolerability of INZ-701 and characterize its pharmacokinetic and pharmacodynamic profile, including plasma pyrophosphate (PPi) and other biomarker levels, to establish a recommended dosing regimen for further clinical development.
Drug Discovery World
DECEMBER 13, 2023
It demonstrated a differentiated in vitro activity profile across several assays compared with small molecule and antibody inhibitors of CD73 in clinical development. Cidara is currently advancing its dual CD73/PD-1 inhibitor DFC and CBO421 in preclinical studies.
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The Pharma Data
APRIL 11, 2021
Monitor blood pressure after 1 week, at least monthly thereafter, and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Our approach centers on creating new oncology medicines that unequivocally work early in clinical development and will matter to patients. About Lilly Oncology.
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The Pharma Data
JANUARY 3, 2021
The pharmacokinetics of nasally administered Foralumab will also be evaluated. Patient reported outcome to assess clinical responses related to COVID-19 symptoms, as per the FDA guidelines, will also be collected.
The Pharma Data
SEPTEMBER 19, 2020
Basel, 19 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it presented the latest results from three Phase III studies from the Tecentriq® (atezolizumab) clinical development programme in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
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The Pharma Data
SEPTEMBER 1, 2020
Pregnancy outcomes in the ozanimod multiple sclerosis clinical development program. Inhibition of drug transporter breast cancer resistance protein has no effect on the pharmacokinetics of major active metabolites of ozanimod. Presentation Topic: Disease Modifying Therapies – Risk Management. Author: Minton. Author: Fox.
The Pharma Data
AUGUST 29, 2020
Oral, investigational complement factor B inhibitor LNP023 substantially improved hematological response as add-on therapy to eculizumab. To date, after at least six months of stable LNP023 add-on therapy, and at the investigators’ discretion, seven patients (70%) have discontinued eculizumab and remained on LNP023 as monotherapy.
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Agency IQ
SEPTEMBER 15, 2023
The committee also made recommendations regarding pharmacokinetic and safety assessments. When looking at several pharmacokinetic studies, the FDA found that the 10 mg oral dose of phenylephrine has a very low bioavailability of less than 1% and, subsequently, low systemic alpha-1 adrenergic activity.
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Drug Discovery World
JANUARY 31, 2024
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. With the drug development expertise and successful track records of the Onward Therapeutics team, we have moved forward from the cell line development, scale up, 1,000-litre?
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Drug Discovery World
AUGUST 8, 2022
Zero bleeds were reported in the eight participants treated with the therapy once monthly. . SS: The data of FRONTIER1 are encouraging and present an opportunity to develop a treatment for people with haemophilia A who may benefit from less frequent administration 1,2. ? Available at: [link] Accessed: July 2022.
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The Pharma Data
DECEMBER 21, 2020
UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,
The Pharma Data
JULY 21, 2021
In the ongoing Phase 2a (NCT04003103) randomized, double-blind, parallel assignment, placebo-controlled, multicenter trial in adults at low-risk for acquiring HIV-1 infection, participants were randomly assigned (2:2:1) to one of three oral once-monthly therapy groups: islatravir 60 mg, islatravir 120 mg or placebo.
The Pharma Data
DECEMBER 5, 2020
” In the trial, the 49 patients evaluated had a median of five prior lines of therapy (range: 2-17) with 100% being triple-refractory and 57% being penta-refractory; all patients were refractory to anti-CD38 therapy. With a median follow up of 2.6 Multiple myeloma is not curable despite treatment advances.
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The Pharma Data
DECEMBER 13, 2020
The Phase 2b trial will also evaluate efficacy on other histology endpoints (fibrosis), assessment of metabolic and non-metabolic parameters, pharmacokinetic assessment as well as safety and tolerability. Currently no curative or specific therapies are available. The Phase 2b trial is expected to begin during the second half of 2021.
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The Pharma Data
NOVEMBER 4, 2020
Food and Drug Administration (FDA) Breakthrough Therapy and Fast Track Designations, is now in pivotal testing, and CTP-692 for schizophrenia is currently on track for topline data readout in the first quarter of 2021,” said Roger Tung, Ph.D., CTP-543 for moderate to severe alopecia areata, which received U.S.
The Pharma Data
APRIL 7, 2022
“At Pfizer, we have a strong heritage in, and commitment to, fighting infectious diseases, most recently evidenced by our delivery of the first authorized vaccine and oral therapy to combat COVID-19,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. Sisunatovir has been granted Fast Track designation by the U.S.
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Alta Sciences
APRIL 17, 2024
Psychedelics Psychedelic therapy (or psychedelic-assisted therapy) refers to the use of psychedelic drugs, such as psilocybin, MDMA, LSD, ketamine, and ayahuasca, to treat mental disorders, especially those that have no effective treatments available or are treatment resistant.
The Pharma Data
JULY 12, 2021
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. No Pharmacokinetic Interaction Between Novel NNRTI MK-8507 and Islatravir.
LifeSciVC
APRIL 24, 2024
There is a continuum of evidence for a given target – at one end are novel targets with some evidence of importance in disease, and at the other end are “de-risked” targets where the biology is precedented with an approved product or late-stage clinical asset(s). with gene editing or gene therapy, enzyme replacement therapy), agonism (e.g.,
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Drug Target Review
JULY 1, 2024
Overall, SRP-001’s modulation of pain signalling genes and pathways through endocannabinoid enhancement and FAAH inhibition supports its potential as an effective non-opioid pain therapeutic, validating the planned clinical trials. was founded in 2016 to develop safer, non-opioid therapies for acute and chronic pain.
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