Bioavailability

Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline

Retrieved on: 
Wednesday, February 14, 2024

Reflection paper on investigations of pharmacokinetics in

Key Points: 
    • Reflection paper on investigations of pharmacokinetics in
      the obese population
      Table of contents
      1.
    • References .............................................................................................. 9

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 2/12

      1.

    • This is considered
      a shortcoming that is potentially compounded by obese patients often being poorly represented in
      clinical studies.
    • The specific aims of this reflection paper are to:
      ?

      describe how the effects of obesity can be investigated during clinical medicinal product
      development.

    • ?

      provide recommendations on when investigations of the effect of obesity on the PK of a
      medicinal product should be particularly considered.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 3/12

      ?

      discuss how to reflect PK (and/or PK/PD) findings in weight/weight-based dosing
      recommendations.

    • Absorption
      Reduced rate of absorption linked to locally reduced blood flow (8) is reported for the subcutaneous
      and transdermal routes in obese subjects.
    • Distribution
      The distribution of medicinal products is driven by body composition, regional blood flow and binding to
      tissue and plasma proteins.
    • Obese subjects have a larger absolute lean body weight (LBW) as well as fat mass.
    • The physicochemical properties of a medicinal product (lipophilicity, polarity, molecular size, and
      degree of ionization) influence its distribution in the body.
    • In BMI class III obese
      subjects, the blood flow per gram of fat is significantly lower than that observed in class I obese or
      lean subjects (4).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 4/12

      An increased amount of alpha-1-acid-glycoprotein (AAG), linked to a chronic inflammatory state, is
      reported in obese individuals.

    • Fatty infiltrations are present in the liver for 90% of obese subjects, with the extent of the infiltrations
      being proportional to the degree of obesity.
    • In some cases, in particular for CYP3A4 metabolized medicinal products,
      bodyweight normalized clearance can be lower in obese patients (23).
    • Based on presently available data, it has been suggested that uptake transporters

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

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      are downregulated while efflux transporters may be upregulated (31).

    • Platelet hyper-reactivity is also observed,
      which can impair the response to anti-platelet medicinal products in obese patients (42, 43).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

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      3.

      the medicinal product properties and scientific literature indicate that obesity may lead to a
      marked effect on elimination and/or distribution or on the PK/PD relationship.

    • These
      models may aid in extrapolating the known efficacy and safety in the non-obese population to the
      obese population.
    • The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients
      Before and One Year After Bariatric Surgery.
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

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      41.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

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Orexo's OX640 development results to be presented at the 2024 AAAAI Annual Meeting in Washington, DC

Retrieved on: 
Tuesday, February 6, 2024

), (STO:ORX) (OTCQX:ORXOY), today announces the presentation of its nasal epinephrine powder product OX640 at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

Key Points: 
  • ), (STO:ORX) (OTCQX:ORXOY), today announces the presentation of its nasal epinephrine powder product OX640 at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.
  • The AAAAI annual meeting is taking place in Washington, DC, February 23-26, 2024.
  • OX640 is Orexo's nasal epinephrine powder product for the acute treatment of severe allergic reactions, including anaphylaxis.
  • Robert Rönn, SVP and Head of R&D, said: "We are honoured that the AAAAI program committee selected our OX640 abstract to be presented at this high-profile late breaking oral abstract session.

Orexo's OX640 development results to be presented at the 2024 AAAAI Annual Meeting in Washington, DC

Retrieved on: 
Tuesday, February 6, 2024

), (STO:ORX) (OTCQX:ORXOY), today announces the presentation of its nasal epinephrine powder product OX640 at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

Key Points: 
  • ), (STO:ORX) (OTCQX:ORXOY), today announces the presentation of its nasal epinephrine powder product OX640 at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.
  • The AAAAI annual meeting is taking place in Washington, DC, February 23-26, 2024.
  • OX640 is Orexo's nasal epinephrine powder product for the acute treatment of severe allergic reactions, including anaphylaxis.
  • Robert Rönn, SVP and Head of R&D, said: "We are honoured that the AAAAI program committee selected our OX640 abstract to be presented at this high-profile late breaking oral abstract session.

Lobe Sciences Initiates Phase 1 Clinical Trial of L-130

Retrieved on: 
Tuesday, June 27, 2023

Lobe Sciences Ltd. (OTCQB: LOBEF) (CSE: LOBE) ("Lobe" or the "Company"), a biopharmaceutical company focused on developing transformative medicines to treat rare diseases today announced the initiation of a Phase 1, pharmacokinetic clinical study of L-130, a proprietary stabilized psilocin analogue drug candidate in healthy volunteers.

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 announced the initiation of a Phase 1, pharmacokinetic clinical study of L-130, a proprietary stabilized psilocin analogue drug candidate in healthy volunteers.
  • We believe L-130, with its potent activity on the serotonin receptor may offer a unique solution to CCH patients” added Mr. Young.
  • All subjects will be evaluated for impacts on cognition and anxiolytic effects on day 1, 7 and 28.
  • Full completion of the study is expected in Q3 2023 and results will be used to determine L-130 dose levels for a planned Phase 2a study in chronic cluster headaches.

Viridian Therapeutics Announces Presentations at the 2023 Annual Meeting of the Association for Research in Vision and Ophthalmology

Retrieved on: 
Thursday, April 20, 2023

WALTHAM, Mass., April 20, 2023 (GLOBE NEWSWIRE) -- Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today announced that multiple abstracts featuring updates on the Company’s investigational therapies for the treatment of thyroid eye disease (TED)—including new preclinical research on VRDN-003—will be presented at the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO 2023), to be held April 23-27, 2023, in New Orleans, Louisiana.

Key Points: 
  • WALTHAM, Mass., April 20, 2023 (GLOBE NEWSWIRE) -- Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today announced that multiple abstracts featuring updates on the Company’s investigational therapies for the treatment of thyroid eye disease (TED)—including new preclinical research on VRDN-003—will be presented at the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO 2023), to be held April 23-27, 2023, in New Orleans, Louisiana.
  • A platform session will feature the proof-of-concept results from the Phase 1/2 trial of VRDN-001 in patients with TED, while two posters will present new preclinical pharmacokinetic and bioavailability data on VRDN-002 as well as pharmacokinetic, pharmacodynamic, and safety data from healthy volunteers treated with VRDN-002.
  • Two additional poster presentations will highlight the design, characterization, and preclinical pharmacokinetics of VRDN-003.
  • VRDN-002 and VRDN-003 are next-generation, half-life extended antibody antagonists to the insulin-like growth factor-1 receptor (IGF-1R), in development for TED.

Bryn Pharma’s UTULY™ 13.2mg Intranasal Epinephrine Spray Provides Enhanced PK Profile (higher and more sustained) Compared to 0.3mg Epinephrine Autoinjector (EpiPen) in Subjects with and without Nasal Congestion

Retrieved on: 
Tuesday, March 28, 2023

The new research presented at the American Society for Clinical Pharmacology & Therapeutics (ASCPT) annual meeting in Atlanta, Ga., showed that nasal congestion enhanced peak levels of epinephrine after intranasal administration of UTULY.

Key Points: 
  • The new research presented at the American Society for Clinical Pharmacology & Therapeutics (ASCPT) annual meeting in Atlanta, Ga., showed that nasal congestion enhanced peak levels of epinephrine after intranasal administration of UTULY.
  • The poster, “The Effect of Nasal Congestion on the Bioavailability of Intranasally Administered Epinephrine in Healthy Adult Subjects with Seasonal Allergies,” can be found here .
  • UTULY is an investigational self-administered form of epinephrine being studied for the treatment of type 1 allergic reactions, including anaphylaxis.
  • These data show that UTULY is absorbed as fast as with an autoinjector, but also offers a higher and more sustained exposure of epinephrine.

Bryn Pharma UTULY™ Phase 3 Data accepted as Late-Breaker at the 2023 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting

Retrieved on: 
Wednesday, February 15, 2023

The poster, “13.2mg Intranasal Epinephrine Spray Demonstrates Comparable PK/PD and Safety to 0.3mg Epinephrine Autoinjector,” will be presented on Friday, February 24 at 3:15pm CT.

Key Points: 
  • The poster, “13.2mg Intranasal Epinephrine Spray Demonstrates Comparable PK/PD and Safety to 0.3mg Epinephrine Autoinjector,” will be presented on Friday, February 24 at 3:15pm CT.
  • New research has also been accepted at the American Society for Clinical Pharmacology & Therapeutics (ASCPT) annual meeting in Atlanta, Ga., March 22-24, 2023.
  • We understand the importance of treatment without hesitation and the need for treatment options that reach maximum concentration quickly.
  • We are dedicated to a strong scientific foundation for our innovative investigational approach with UTULY, and look forward to presenting these data in the coming months.”

EQS-News: PROTEXT MOBILITY, INC. (TXTM) AND RSAMMDA LLC (DELAWARE) PROVIDES SHAREHOLDER UPDATE

Retrieved on: 
Thursday, November 3, 2022

Protext Mobility, Inc. (OTC PINK: TXTM) and RSAMMDA LLC (Delaware) (RSAMMDA.LLC) are pleased to provide the following shareholder update and announce an initial order for 2.33 million pounds of Genus Cannabis Sativa under a supply agreement.

Key Points: 
  • Protext Mobility, Inc. (OTC PINK: TXTM) and RSAMMDA LLC (Delaware) (RSAMMDA.LLC) are pleased to provide the following shareholder update and announce an initial order for 2.33 million pounds of Genus Cannabis Sativa under a supply agreement.
  • Dr. Ahmed Jamaloodeen (Dr.J), Protext Chairman commented, This is a terrific milestone and demonstrates years of hard work and relentless pursuit of educating the masses and government collaboration.
  • The specific strain we are growing for this order is Charlottes Angel for high percentage CBD flower and biomass.
  • For further information, or inquiries relating to partnerships in SA, JV opportunities and/or off-take/supply agreements please feel free to contact us

PROTEXT MOBILITY, INC. (TXTM) AND RSAMMDA LLC (DELAWARE) PROVIDES SHAREHOLDER UPDATE

Retrieved on: 
Tuesday, November 1, 2022

Dr. Ahmed Jamaloodeen (Dr.J), Protext Chairman commented, This is a terrific milestone and demonstrates years of hard work and relentless pursuit of educating the masses and government collaboration.

Key Points: 
  • Dr. Ahmed Jamaloodeen (Dr.J), Protext Chairman commented, This is a terrific milestone and demonstrates years of hard work and relentless pursuit of educating the masses and government collaboration.
  • The specific strain we are growing for this order is Charlottes Angel for high percentage CBD flower and biomass.
  • Our proprietary, branded CBD product line and online marketplace is anticipated to launch shortly.
  • For further information, or inquiries relating to partnerships in SA, JV opportunities and/or off-take/supply agreements please feel free to contact us

Aptose Reports Results for the Third Quarter 2022

Retrieved on: 
Tuesday, November 1, 2022

SAN DIEGO and TORONTO, Nov. 01, 2022 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, today announced financial results for the three and nine-month periods ended September 30, 2022 and provided a corporate update.

Key Points: 
  • The net loss for the quarter ended September 30, 2022 was $9.8 million ($0.11 per share) compared with $11.3 million ($0.13 per share) for the quarter ended September 30, 2021.
  • Total cash and cash equivalents and investments as of September 30, 2022 were $55.4 million.
  • Based on current operations, Aptose expects that cash on hand and available capital provide the Company with sufficient resources to fund planned Company operations including research and development into the first quarter of 2024.
  • A summary of the results of operations for the three and nine-month periods ended September 30, 2022 and 2021 is presented below: