Tmax

Biora Therapeutics Achieves Positive Interim Results for Clinical Trial of BT-600, Advancing NaviCap™ Platform Development

Retrieved on: 
Thursday, April 4, 2024
Toxicity, TNF, Absorption, Ulcerative colitis, Plasma, Tmax, SAN, Patient, UC, MD, Cmax, IBD, Clinical trial, Therapy, Safety, Pharmacokinetics, SAD, JAK, Pharmaceutical industry

SAN DIEGO, April 04, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today shared additional positive interim results from the single-ascending dose (SAD) clinical trial of BT-600, which is a drug-device combination consisting of the orally administered NaviCap™ device that delivers a proprietary liquid formulation of tofacitinib to the colon. BT-600 is being developed for the potential treatment of patients with ulcerative colitis (UC). The SAD portion of the phase 1 randomized, double-blind, placebo-controlled clinical trial tested the tolerability and pharmacokinetics of BT-600 at 5 mg and 10 mg doses of tofacitinib, compared to placebo, in healthy adult participants.

Key Points: 
  • BT-600 is being developed for the potential treatment of patients with ulcerative colitis (UC).
  • The SAD portion of the phase 1 randomized, double-blind, placebo-controlled clinical trial tested the tolerability and pharmacokinetics of BT-600 at 5 mg and 10 mg doses of tofacitinib, compared to placebo, in healthy adult participants.
  • We believe this could lead to better outcomes for patients suffering from UC.”
    According to the interim clinical data, all pharmacokinetic endpoints were met in all study participants.
  • The mean time to reach maximum concentration (Tmax) was 8–10 hours following administration of BT-600, versus 0.5-1.0 hours for conventional oral tofacitinib.

Annovis Announces Publication That Supports Understanding of Buntanetap’s Mechanism of Action in Humans

Retrieved on: 
Monday, April 1, 2024
CSF, Tmax, AUC, Patient, Cerebrospinal fluid, Cmax, Kinetics, APP, SILK

MALVERN, Pa., April 01, 2024 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, today announced the publication of new data from an earlier study supporting buntanetap as a translational inhibitor of amyloid precursor protein (APP) in patients with early Alzheimer’s Disease (AD).

Key Points: 
  • Buntanetap is an oral molecule that selectively binds to an iron-responsive element in the mRNA of APP and other neurotoxic proteins and inhibits their translation.
  • Through this mechanism, buntanetap was shown to decrease the production of amyloid beta (Aβ), a key hallmark in AD.
  • Here, SILK was used to measure the kinetics of APP in early AD patients and to quantify Aβ40 in CSF.
  • Notably, the analysis of adverse events demonstrated no dose-dependent effect of buntanetap compared to placebo, affirming the drug’s safety and tolerability.

Innocan Pharma Announces Study Findings that LPT-CBD maintains its prolonged release in Rabbits

Retrieved on: 
Monday, February 26, 2024
AB, LPT, CMAX, Blood, Animal, Dog, Sheep, Goat, Tmax, Pharmacokinetics, Rabbit, Half-life, Mouse

The fundamentals of LPT-CBD lay in its ability to slowly release CBD into the blood stream.

Key Points: 
  • The fundamentals of LPT-CBD lay in its ability to slowly release CBD into the blood stream.
  • In the Company's latest study conducted on rabbits, the results showed additional supportive data for the long exposure of CBD obtained following a single subcutaneous LPT-CBD injection.
  • The Company is encouraged by these study results as they confirm the approach the Company is taking with its LPT platform.
  • In the study conducted on rabbits, the animals were collected for blood analysis of the drug for up to 11 days.

Inhibikase Therapeutics Granted Pre-NDA Meeting with the FDA for IkT-001Pro

Retrieved on: 
Monday, December 4, 2023
Food, Syndrome, Chronic myelogenous leukemia, Acute lymphoblastic leukemia, Tmax, FDA, Plasma, Imatinib, Blood, NDA, Therapy, PDGFR, Parkinson's disease, Pancreatic serous cystadenoma, Patient, Mastocytosis

BOSTON and ATLANTA, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease, Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced the U.S. Food and Drug Administration has granted a pre-New Drug Application (pre-NDA) meeting to be held in January 2024 to discuss the requirements for approval of IkT-001Pro and to review the data establishing doses of IkT-001Pro bioequivalent to 400 mg and 600 mg imatinib mesylate. The Company expects to provide an update following the meeting.

Key Points: 
  • The Company expects to provide an update following the meeting.
  • “We are pleased that the FDA has granted a pre-NDA meeting to discuss the parameters for approval of IkT-001Pro,” stated Dr. Milton Werner, President and Chief Executive Officer of Inhibikase Therapeutics.
  • Across all doses, there were only mild adverse events observed, including just two adverse events for IkT-001Pro at the highest dose comparison.
  • Pharmacokinetic profiles for imatinib delivered by IkT-001Pro and imatinib mesylate were similar at equivalent doses.

Adicet Bio Highlights ADI-001 Expansion, Persistence and Pharmacodynamic Profile from Ongoing Phase 1 Study at the 65th American Society of Hematology (ASH) Annual Meeting

Retrieved on: 
Sunday, December 10, 2023
Research, FDA, Clinical Trials, Stem Cells, Biotechnology, Health, Pharmaceutical, Science, Oncology, Cytokine, PST, ASH, AUC, ACET, PD, Stem cell factor, Patient, CD19, Tmax, Allele, HLA, Cancer, Cmax, NHL, Pharmacodynamics, Investigator's brochure, Pharmaceutical industry, Vaccine, Medical imaging, Generic drug, Persistence

The data will be provided during a poster presentation at the ASH Annual Meeting on Sunday, December 10, 2023.

Key Points: 
  • The data will be provided during a poster presentation at the ASH Annual Meeting on Sunday, December 10, 2023.
  • “Historically, expansion and persistence of cell therapy products and release of functional cytokines have correlated with patient outcomes.
  • We remain on track to provide a clinical update from the Phase 1 study in NHL patients in the second half of 2024."
  • Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster II
    Date/Time: Sunday, December 10, 2023, from 6:00 - 8:00 p.m. PST

Lobe Sciences Provides Update on L-130 Clinical Program

Retrieved on: 
Thursday, December 7, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Psilocybin, Absorption, Safety, CSE, OTCQB, Plasma, Tmax, Pharmacokinetics, Conference, Cognition, Human, Cmax, Pharmaceutical industry

Lobe Sciences Ltd. (OTCQB: LOBEF) (CSE: LOBE) ("Lobe" or the "Company"), a biopharmaceutical company focused on developing transformative medicines to treat rare diseases today provided an update from the Company’s lead clinical program, L-130, a proprietary stabilized psilocin conjugate drug candidate.

Key Points: 
  • Lobe Sciences Ltd. (OTCQB: LOBEF) (CSE: LOBE) ("Lobe" or the "Company"), a biopharmaceutical company focused on developing transformative medicines to treat rare diseases today provided an update from the Company’s lead clinical program, L-130, a proprietary stabilized psilocin conjugate drug candidate.
  • The Phase 1 study (NCT06035900) was an open label clinical trial in 10 normal and healthy individuals designed to determine the safety and pharmacokinetic parameters of L-130 after a single oral dose.
  • All subjects were evaluated for impacts on cognition and anxiolytic effects on day 1, 7 and 28.
  • The study confirmed the improved pharmacokinetics of L-130 delivered as a shelf-stable, capsule over its inactive prodrug, psilocybin.

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.

Aquestive Therapeutics Reaffirms Timeline and Pathway for Anaphylm™ (epinephrine) Sublingual Film

Retrieved on: 
Wednesday, September 20, 2023
PK, Tmax, Allergy, Emergency, NDA, Cmax, Food and Drug Administration Amendments Act of 2007, Patient, Anaphylaxis, Adrenaline, FDA, Therapy, Food, Pharmaceutical industry

As previously disclosed, Aquestive submitted its revised protocol for the proposed pivotal PK clinical trial to the Food and Drug Administration (FDA) in August 2023.

Key Points: 
  • As previously disclosed, Aquestive submitted its revised protocol for the proposed pivotal PK clinical trial to the Food and Drug Administration (FDA) in August 2023.
  • The Company intends to commence the pivotal trial in the fourth quarter 2023, following alignment with the FDA.
  • In addition, the Company’s current development plan continues to include a standard repeat-dose study of Anaphylm and an already-approved comparator.
  • Further information on this comparison is available in the Company’s corporate presentation located on the Investor page of the Company’s website.

SourceOne Global Partners celebrates 20-year anniversary, reflecting on pioneering a best-in-class high bioavailability technology platform

Retrieved on: 
Thursday, September 7, 2023
Ageing, Cmax, Coenzyme Q10, Softgel, Movement, Fertility, AUC, PDI, Dispersity, Fine chemical, Tmax

CHICAGO, Sept. 07, 2023 (GLOBE NEWSWIRE) -- SourceOne Global Partners is proud to announce the launch of new, science-backed product solutions as it celebrates twenty years as a leading supplier to global nutraceutical brands.

Key Points: 
  • CHICAGO, Sept. 07, 2023 (GLOBE NEWSWIRE) -- SourceOne Global Partners is proud to announce the launch of new, science-backed product solutions as it celebrates twenty years as a leading supplier to global nutraceutical brands.
  • SourceOne’s leading product by market share is its high bioavailable CoQ10 softgel powered by the patented VESIsorb® technology that has gained mass distribution around the world.
  • SourceOne has supplied leading nutraceutical brands in every channel of distribution while penetrating the most profitable global markets.
  • “SourceOne’s achievements over the past twenty years have undoubtedly moved our industry forward,” Rakesh Amin, Founding Partner of Amin Talati Wasserman, said.

Nasus Pharma Announces Publication Of Its Positive Clinical Results With FMXIN002 Intranasal Powder Epinephrine Spray In The Journal Of Allergy And Clinical Immunology In Practice

Retrieved on: 
Tuesday, August 8, 2023
Allergen, Volunteering, PK, Injection, Tmax, Food, Allergy, PBI, Emergency, Biting, Pharmacokinetics, IM, Cmax, Parent, Trial of the century, Nose, Plasma, TEL, Anaphylaxis, AUC, Nasal congestion, Powder, Nasal administration, Death, Fatality, Pharmaceutical industry, Nasus, Adrenaline, Mylan

TEL AVIV, Israel, Aug. 8, 2023 /PRNewswire/ -- Nasus Pharma Ltd a clinical-stage biopharmaceutical company focused on developing needle-free, powder-based Intranasal (PBI) product portfolio, to address acute medical conditions announced the publication of positive results from a clinical study of intranasal powder-based Epinephrine.

Key Points: 
  • FMXIN002 is an investigational intranasal epinephrine powder spray device that is noninvasive, user-friendly and reliable and could provide timely effective rescue for severe potentially life-threatening allergic reactions to food, medications and insect bites.
  • The clinical study provides additional compelling evidence to the robustness of Nasus Pharma's intranasal powder technology already tested in other drugs.
  • "The publication of our results in a prominent scientific journal such as JACI: In Practice will ensure the dissemination of FMXIN002's promise within the relevant medical community."
  • Yet an additional advantage for powder-based formulation of epinephrine, a drug that undergoes rapid degradation in the currently-available short shelf-life liquid dosage forms.