Cmax

Qnovia, Inc. announces positive results from first-in-human pharmacokinetic and safety study of lead asset QN-01, a prescription inhaled smoking cessation therapy

Retrieved on: 
Wednesday, November 29, 2023
Science, Other Science, Pharmaceutical, Health, Tobacco, Health Technology, Clinical Trials, Retail, Smoker, IND, Plasma, MHRA, Patient, Multimedia, Smoke, Nicotine, Tmax, Initial, Pharmacokinetics, CDER, Medication, Therapy, NRT, Cmax, CTA, Smoking cessation, Smoking, Pharmaceutical industry, Research

Qnovia, Inc., a pharma company developing inhaled therapeutics across a variety of indication areas leveraging its proprietary inhaled drug delivery platform, the RespiRxTM, today announced positive results from its first in-human study of QN-01, the company’s lead asset.

Key Points: 
  • Qnovia, Inc., a pharma company developing inhaled therapeutics across a variety of indication areas leveraging its proprietary inhaled drug delivery platform, the RespiRxTM, today announced positive results from its first in-human study of QN-01, the company’s lead asset.
  • QN-01 is an inhaled smoking cessation therapy that is currently being evaluated in the U.S. under FDA’s Center for Drug Evaluation and Research (CDER) and in the U.K. by the Medicines and Healthcare Products Regulatory Agency (MHRA).
  • “We are delighted to share that QN-01 demonstrated a superior pharmacokinetic profile compared to an existing inhaled NRT and was well tolerated.
  • The drug-device combination was well tolerated with no severe adverse events and few minor adverse events typical of inhaled nicotine.

Nasus Pharma Announces Positive Clinical Results of Recent Phase 2 Study With FMXIN002 Intranasal Epinephrine

Retrieved on: 
Tuesday, December 5, 2023
Epinephrine autoinjector, Safety, Powder, Plasma, Food, PBI, Patient, Journal, Fatality, Pharmacokinetics, Caregiver, Parent, Anaphylaxis, Nasal administration, Trial of the century, Cmax, Death, Emergency, Biting, TEL, Injection, Pharmaceutical industry, Medical device, Mylan, Hadassah, Allergy, Adrenaline

TEL AVIV, Israel, Dec. 5, 2023 /PRNewswire/ -- Nasus Pharma Ltd a clinical-stage biopharmaceutical company focused on developing a needle-free, powder-based Intranasal (PBI) product portfolio to address acute medical conditions announced positive results from its latest clinical study of intranasal powder-based Epinephrine.

Key Points: 
  • TEL AVIV, Israel, Dec. 5, 2023 /PRNewswire/ -- Nasus Pharma Ltd a clinical-stage biopharmaceutical company focused on developing a needle-free, powder-based Intranasal (PBI) product portfolio to address acute medical conditions announced positive results from its latest clinical study of intranasal powder-based Epinephrine.
  • Nasus Pharma recently completed an additional phase 2 study (NP-006-Epinephrine) confirming the superiority and safety of its lead FMXIN002 Intranasal Epinephrine product.
  • The recent clinical study explored the safety and efficacy of FMXIN002 in its intended clinical dose and provided additional compelling evidence to the robustness of Nasus Pharma intranasal powder technology already tested in a  prior pilot study ( Tal, et al.
  • "This phase 2  study indicates that powder-based intranasal epinephrine can offer significant clinical advantages, as compared to the currently-available intramuscular route of drug administration and other solution-based intranasal epinephrine programs in development.

Immatics Reports Interim Clinical Data from ACTengine® IMA203 and IMA203CD8 TCR-T Monotherapies Targeting PRAME in an Ongoing Phase 1 Trial

Retrieved on: 
Wednesday, November 8, 2023
Patient, FDA, Research, Pharmacology, Uveal melanoma, Regenerative Medicine Advanced Therapy, Uterine cancer, NSCLC, International Congress on Tuberculosis, Corr, Cmax, Ovarian cancer, Nivolumab, Infrared spectroscopy correlation table, TCR, Appendix, CMC, Neurotoxicity, Lung, SD, DLT, Cytokine release syndrome, Melanoma, ORR, Cell therapy, Triple-negative breast cancer, CET, PRAME, Safety, CRS, Society, Melanoma Research, Diagnosis, Today, Cytopenia, BRAF, Pharmaceutical industry, Vaccine, Medical imaging, MD

The update is focused on IMA203 GEN1 in melanoma at the recently defined recommended Phase 2 dose (RP2D) and the first clinical data for IMA203CD8 GEN2.

Key Points: 
  • The update is focused on IMA203 GEN1 in melanoma at the recently defined recommended Phase 2 dose (RP2D) and the first clinical data for IMA203CD8 GEN2.
  • In line with previous results, IMA203 GEN1 monotherapy was well tolerated at total doses up to 10x109 TCR-T cells infused.
  • The presentation is available on Immatics’ website – covering the complete data set including Phase 1a, Phase 1b Cohort A and the deprioritized Cohort B (IMA203 GEN1 combined with nivolumab).
  • Discussions with FDA to align on patient populations, trial design and CMC aspects concerning the planned Phase 2 trial are ongoing.

DASYNOC™ Uptake into the Blood Remains Consistent When Taken with Omeprazole, Whereas SPRYCEL® Uptake is Significantly More Impaired than Previously Understood

Retrieved on: 
Wednesday, November 8, 2023
Biotechnology, Pharmaceutical, Health, Oncology, PH, FDA, AUC, PPI, Omeprazole, Physician, CML, HIV disease progression rates, Dasatinib, Risk, TKI, Blood, Patient, Death, Solubility, Pharmaceutical industry, Cmax

Xspray has demonstrated that in the DASYNOC CO-PPI Study, DASYNOC’s uptake into blood was not affected 10 hours after taking omeprazole (107 % of intended AUC0-24h and 86% of intended Cmax).

Key Points: 
  • Xspray has demonstrated that in the DASYNOC CO-PPI Study, DASYNOC’s uptake into blood was not affected 10 hours after taking omeprazole (107 % of intended AUC0-24h and 86% of intended Cmax).
  • However, in the SPRYCEL CO-PPI Study, the uptake of SPRYCEL was significantly reduced 10 hours after taking omeprazole (only 12% of the intended AUC0-24h and 4% of the intended Cmax).
  • “We recently published that CML patients, concomitantly treated with TKIs and PPIs, are at a statistically significant 3.5-fold increased risk of death.
  • SPRYCEL was approved in 2006 by the FDA and is the market leading branded product that revolutionized the treatment of CML.

Ascendis Presents Updated and New TransCon™ IL-2 β⁄γ Monotherapy and Combination Therapy Data Confirming Clinical Activity Across Tumor Types at ESMO 2023

Retrieved on: 
Thursday, October 26, 2023
Patient, SCLC, Cmax, ESMO, Pembrolizumab, Colorectal cancer, European Society for Medical Oncology, Eosinophil, Carcinoma, Northern Transcon, Clinical, Oncology, Safety, European Society for Primary Immunodeficiencies, Interleukin, PR, Pharmaceutical industry, Extractive metallurgy

COPENHAGEN, Denmark, Oct. 26, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) reported updated and new data from its ongoing Phase 1/2 IL-Believe Trial of TransCon IL-2 β⁄γ in a poster presentation at ESMO 2023, the annual meeting of the European Society of Medical Oncology held in Madrid, Spain. The data included longer-term follow up of previously presented TransCon IL-2 β⁄γ monotherapy data from the IL-Believe Trial, and was the first presentation of dose escalation data informing recommended Phase 2 dose (RP2D) for TransCon IL-2 β⁄γ in combination with a checkpoint inhibitor.

Key Points: 
  • The data included longer-term follow up of previously presented TransCon IL-2 β⁄γ monotherapy data from the IL-Believe Trial, and was the first presentation of dose escalation data informing recommended Phase 2 dose (RP2D) for TransCon IL-2 β⁄γ in combination with a checkpoint inhibitor.
  • As of the August 15, 2023 data cutoff, 46 patients were enrolled into dose escalation: 25 to monotherapy and 21 to combination therapy.
  • RP2D for IL-Believe is 120 µg/kg of TransCon IL-2 β⁄γ administered intravenously every three weeks in both the monotherapy and combination therapy arms.
  • Additional details and highlights from the ESMO poster are available on the Investor & News section of the Ascendis Pharma website at https://investors.ascendispharma.com.

Therini Bio Announces Interim Results from the Phase 1 Trial of THN391 for the Potential Treatment of Dementia

Retrieved on: 
Tuesday, October 24, 2023
Fibrin, Ageing, Half-life, Cmax, Publication, Treatment, Boston Park Plaza, MAD, SAD, Dementia, Poster, Safety, Retina, Vaccine

SACRAMENTO, Calif., Oct. 24, 2023 (GLOBE NEWSWIRE) -- Therini Bio, Inc., a biotech company focused on developing fibrin targeted therapies to treat inflammatory neurodegenerative and retinal diseases, today announced interim results from the Phase 1 trial of its lead candidate, THN391, for the treatment of dementia. The data will be detailed in a poster presentation at the 16th Clinical Trials on Alzheimer’s Disease (CTAD) conference taking place from October 25-27, 2023, in Boston, MA.

Key Points: 
  • SACRAMENTO, Calif., Oct. 24, 2023 (GLOBE NEWSWIRE) -- Therini Bio, Inc., a biotech company focused on developing fibrin targeted therapies to treat inflammatory neurodegenerative and retinal diseases, today announced interim results from the Phase 1 trial of its lead candidate, THN391, for the treatment of dementia.
  • Vascular dysfunction is a key driver in many neurodegenerative diseases, with fibrin playing a major role.
  • THN391 is a potential first-in-class, therapeutic, monoclonal antibody that is designed to target the inflammatory properties of fibrin without disrupting coagulation and protective innate immunity.
  • Data from the first two cohorts, 0.3 mg/kg and 1.0 mg/kg, demonstrated a half-life of approximately 50 days in both groups.

Ryvu Therapeutics Provides an Update on the Progress of RVU120 Phase I Studies in Patients with Solid Tumors and AML/HR-MDS, and Presents the Updated Development Plan for RVU120

Retrieved on: 
Monday, October 23, 2023
Medulloblastoma, Bone marrow, Plasma, AUC, Acute myeloid leukemia, Cmax, ESMO, Erythropoiesis, Principal investigator, Aes, PD, Congress, MD, Adenoid cystic carcinoma, CEST, Ruxolitinib, Cell, Data, Syndrome, All-comers track meet, Phase, SD, Risk, Webcast, Pancreatic cancer, Venetoclax, NPM1, WSE, ADCC, Safety, European Society for Medical Oncology, Patient, AML, Sarcoma, Pharmaceutical industry, Medical imaging, Dietary supplement

The total budget for the Phase II clinical development of RVU120 aligns with the estimates initially announced in the Ryvu Development Plans for 2022-2024.

Key Points: 
  • The total budget for the Phase II clinical development of RVU120 aligns with the estimates initially announced in the Ryvu Development Plans for 2022-2024.
  • The presented RVU120 development plan aligns with the budget outlined in Ryvu Development Plans for 2022-2024 and targets multi-billion-dollar market potential.
  • At the ESMO Congress 2023, Ryvu announced updated clinical Phase I data from Phase I/II study of RVU120 in relapsed/refractory metastatic advanced solid tumors.
  • Ryvu will host a webinar today (Monday, October 23) at 9:00 am CEST to discuss further RVU120 development plans.

Ambrx Provides Safety and Efficacy Data from Ongoing Phase 1/2 APEX-01 Trial of ARX517 in mCRPC at ESMO Congress

Retrieved on: 
Monday, October 16, 2023
Congress, Cohort, HIV disease progression rates, Abstract, European Society for Medical Oncology, Toxicity, Safety, Half-life, PSMA, CEST, FDA, ESMO, RECIST, Oncology, Webcast, Lymphocytopenia, Clinical trial, Trae tha Truth, PSA, Instability, Spacecraft, Neoplasm, Prostate cancer, ADC, Cmax, Patient, Pharmaceutical industry, Vaccine, Copper, Palladium, Flour

SAN DIEGO, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma, Inc., or Ambrx, (NASDAQ: AMAM), today announced that two abstracts detailing updated safety and efficacy data from the ongoing Phase 1/2 trial, APEX-01 (NCT04662580), evaluating ARX517 for metastatic castration-resistant prostate cancer (mCRPC) were made available as part of the 2023 European Society of Medical Oncology (ESMO) Congress 2023 meeting, taking place in Madrid, Spain, October 20-24, 2023.

Key Points: 
  • APEX-01 opened for enrollment in July 2021, and is the only ongoing clinical trial in the United States targeting PSMA with an antibody-drug conjugate (ADC).
  • The two clinical abstracts submitted to ESMO regarding the APEX-01 trial used a cutoff date of May 3, 2023.
  • Ambrx will provide more mature data with a later data cutoff date, including a significantly greater number of patients from the dose expansion portion of APEX-01, in the ESMO posters and in its associated press release.
  • Click here to register and attend Ambrx’s KOL Event discussing additional ARX517 data presented at ESMO and showcasing presentations from prostate cancer experts, or visit www.ambrx.com .

Entera Bio Reports Rapid Pharmacodynamic (PD) Response and Consistent Pharmacokinetic (PK) Data for its First-in-Class Oral PTH(1-34) Mini Tablets at the ASBMR 2023 Annual Meeting

Retrieved on: 
Monday, October 16, 2023
Annual general meeting, Phosphorus, Calcium, Hypoparathyroidism, Pharmacokinetics, Female, BMD, Plasma, PTH, Research and development, Risk, Bone, AUC, Young adult, Patient, Health status of Asian Americans, Bone fracture, Osteoporosis, American Society for Bone and Mineral Research, Tablet, PD, Athlete, Cmax, Pharmaceutical industry, Birth control, Woman, MD, Entera

A Phase 1 study comparing oral EB613, subcutaneous (SC) hPTH(1-34) 20 g (Forteo®) and a new generation of Entera’s oral peptide delivery platform is ongoing.

Key Points: 
  • A Phase 1 study comparing oral EB613, subcutaneous (SC) hPTH(1-34) 20 g (Forteo®) and a new generation of Entera’s oral peptide delivery platform is ongoing.
  • One of the first objectives of this study is to rapidly evaluate the pharmacodynamic (PD) effects of Entera’s oral PTH(1-34) tablets.
  • Abstract Title: Pharmacokinetic (PK) Profile of EBP05/EB613 Oral Teriparatide Tablets in Women of Post Menopausal Age Versus Young Adult Men.
  • “The data showed a consistent PK profile following administration of oral EBP05 tablets in both young men and women of menopausal age.

Kronos Bio Presents Positive Preliminary Data from Phase 1 Dose Escalation Portion of Phase 1/2 KB-0742 Study at AACR-NCI-EORTC

Retrieved on: 
Friday, October 13, 2023
Cancer, Lung cancer, Sarcoma, City of Hope National Medical Center, Drug, M.D, Plasma, Vomiting, Breast, AACR, PIN, CDK9, Safety, Half-life, Nausea, Therapy, RECIST, City, Neutropenia, Fatigue, KRON, Chordoma, Mechanism of action, SAN, Patient, Lung, Q&A, Neoplasm, PR, Cmax, Conference, Myxoid liposarcoma, Pharmaceutical industry

The preliminary analysis included 28 patients enrolled in a dose escalation study who received doses from 10 mg up to 60 mg (data cut-off September 1st, 2023).

Key Points: 
  • The preliminary analysis included 28 patients enrolled in a dose escalation study who received doses from 10 mg up to 60 mg (data cut-off September 1st, 2023).
  • KB-0742 also demonstrated dose proportional exposure and target engagement and a 24-hour plasma half-life, enabling intermittent dosing.
  • Because the maximum tolerated dose has not yet been identified, enrollment in the dose escalation portion continues and dosing of patients at the 80 mg dose level is underway.
  • “These positive preliminary efficacy and safety data underscore the promise of KB-0742 to treat patients with transcriptionally addicted tumors.