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A Phase I/IIa Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Macuneos in Healthy Volunteers and Patients with Dry Age-Related Macular Degeneration (Dry AMD)

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Trial Profile

A Phase I/IIa Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Macuneos in Healthy Volunteers and Patients with Dry Age-Related Macular Degeneration (Dry AMD)

Status: Planning
Phase of Trial: Phase I/II

Latest Information Update: 30 Apr 2021

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At a glance

  • Drugs Macuneos (Primary)
  • Indications Dry age-related macular degeneration; Stargardt disease
  • Focus Adverse reactions; First in man; Pharmacodynamics; Pharmacokinetics
  • Acronyms MACA-PK

    • Most Recent Events

    • 29 Apr 2021 According to a Biophytis media release, the company expect to initiate this trial in the second half of 2021, subject to regulatory review and approval as well as COVID-19-related delays and the impact of the pandemic on operational capabilities.
    • 29 Apr 2021 According to a Biophytis media release, the company received non-dilutive funding of 980,000 euro from the public investment bank BPI France's DeepTech program for MACA program of Macuneos (BIO201) in dry Age-Related Macular Degeneration (AMD).
    • 26 Jun 2019 According to a Biophytis media release, the preclinical results and initial discussion regarding the potential design of the phase 1 clinical trial support the companys plan to hold a scientific advice meeting with EU regulatory agencies in the second half of 2019 regarding clinical development of Macuneos (BIO201) for the potential treatment of dry AMD and Stargardt disease.
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