RAINBOW study design enables rapid advancement into the company’s planned Phase III efficacy trial Leiden, The Netherlands, May 22- 2023 – Azafaros B.V. today announced that the first US site for the Phase II RAINBOW study, led by Dr Marc Patterson of the Mayo Clinic in Minnesota, has received Institutional Review Board approval. The clinical …
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Niemann-Pick Type C News
Azafaros Receives FDA’s IND Clearance and Fast Track Designation
Azafaros B.V. announced in January 2023 that it Investigational New Drug (IND) clearance from the United States Food and Drug Administration (FDA) to conduct a clinical Phase 2 trial for its lead asset, AZ-3102, for the treatment of GM2 gangliosidosis (GM2) and Niemann-Pick disease type C (NP-C). In addition to the IND clearance, the FDA …
IntraBio Completes Recruitment for IB1001 NPC Pivotal Clinical Trial
OXFORD, UK / December 08, 2022 / IntraBio Inc announced today that it has completed recruitment for its Pivotal Trial, Effects of N-Acetyl-L-Leucine on Niemann-Pick disease type C (NPC): A Phase III, randomized, placebo-controlled, double-blind, crossover study (IB1001-301 – NCT05163288). Enrolment for IB1001-301 commenced in September 2022. Patients were screened across 13 multinational trial sites …