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A Phase 2 study of ALPHA-1062 nasal spray formulation to treat traumatic brain injury

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Trial Profile

A Phase 2 study of ALPHA-1062 nasal spray formulation to treat traumatic brain injury

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 23 Aug 2023

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At a glance

  • Drugs Benzgalantamine (Primary)
  • Indications Traumatic brain injuries
  • Focus Therapeutic Use
  • Most Recent Events

    • 22 Aug 2023 According to an Alpha Cognition media release, the company expects Alpha Seven Therapeutics will initiate the additional toxicity direct manufacturing and manufacturing work, which would be anticipated to complete in 2H, 2024. Alpha Seven Therapeutics would then be in the position to file an IND for ALPHA-1062IN. First patient enrolment expected in during 2H 2023 and in 2024 Last patient enrolled followed by initial Phase 2 clinical results.
    • 25 Aug 2022 According to an Alpha Cognition media release, the company plans to request an FDA meeting to discuss the clinical development of intranasal ALPHA-1062 for the treatment of traumatic brain injury (TBI). It is anticipated that this meeting will take place in Q4 2022.
    • 07 Oct 2021 According to an Alpha Cognition media release, the company is planning to initiate this trial in fall with top-line data read-out in late Q1 2022.

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