PIPE-307 FOR MULTIPLE SCLEROSIS

Pipeline Therapeutics Receives IND Clearance from FDA to Initiate Phase 1b/2a Study of PIPE-307 in Patients with Relapsing-Remitting Multiple Sclerosis

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Monday, March 28, 2022
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FDA clearance to initiate our Phase 1b/2a clinical study of PIPE-307 is a major regulatory milestone for Pipeline, as it allows us to proceed with the evaluation of PIPE-307 in RRMS patients, said Carmine Stengone, President and CEO of Pipeline.

Key Points: 
  • FDA clearance to initiate our Phase 1b/2a clinical study of PIPE-307 is a major regulatory milestone for Pipeline, as it allows us to proceed with the evaluation of PIPE-307 in RRMS patients, said Carmine Stengone, President and CEO of Pipeline.
  • Our objective with PIPE-307 is to develop the first effective treatment that can restore myelin and improve outcomes for patients.
  • The Phase 1b/2a clinical trial of PIPE-307 will be conducted as a randomized, double-blind, placebo-controlled dose-ranging study in multiple sites across the US.
  • In March 2022, the Company received clearance from the U.S. Food and Drug Administration to proceed with a Phase 1b/2a study of PIPE-307 in RRMS patients.

Pipeline Therapeutics Reports Positive Phase 1 Clinical Results for PIPE-307, a Neuroregenerative Therapeutic for the Treatment of Multiple Sclerosis

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Thursday, March 10, 2022
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Currently, there are no approved medicines that support myelin restoration, which represents a significant unmet medical need in the treatment of MS.

Key Points: 
  • Currently, there are no approved medicines that support myelin restoration, which represents a significant unmet medical need in the treatment of MS.
  • The Phase 1 clinical results reported today comprised multiple dose cohorts of PIPE-307 in a total of 70 healthy volunteer subjects.
  • We believe that PIPE-307, as a first-in-class myelin restoration therapeutic, represents a differentiated and clinically-validated approach for the treatment of MS.
  • These encouraging Phase 1 results give us great confidence to advance PIPE-307 into clinical studies with MS patients as soon as possible.