Neobiosis Announces FDA Approval of IND for Use of ViXomeTM in COVID-19 'Post Covid Syndrome'
GAINESVILLE, Fla., June 12, 2023 (Newswire.com) - Neobiosis, is a leading research and manufacturing biotechnology company focused on pioneering the development of novel therapeutics from perinatal tissues as a new class of medicines. Today, Neobiosis announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for ViXome™, its drug for the treatment of 'Post COVID Syndrome (AKA "Long Haul COVID Syndrome").
"This is an important milestone for Neobiosis and we are excited to be advancing ViXome, a refined product extracted from thoroughly screened and sterile amniotic fluid obtained at the time of c-section of at-term pregnancies, into clinical development," said Ian A. White, Ph.D., CEO and CSO of Neobiosis. "We are eager to confirm our preclinical data in the clinic and expect to begin enrolling patients in Phase 1 during the second quarter of 2024."
ViXome, an acellular product derived from amniotic fluid, contains a heterogeneous population of growth factors, cytokines, chemokines, microRNAs and exosomes, which in pre-clinical testing has demonstrated potent immunomodulatory and pro-reparative effects.
The Phase I/IIa study will thoroughly investigate the safety and clinical efficacy of ViXome. Neobiosis products are processed in state-of-the-art, FDA-registered and FDA-inspected cGMP-compliant cleanrooms in Gainesville, FL. Neobiosis performs its research and development (R&D) at the University of Florida (UF) Sid Martin Innovate Biotechnology Institute in Alachua, FL., the world-recognized leader in biotechnology incubation.
"We are excited to be one of the first companies in the US to advance a potential therapeutic for the treatment of a devastating disease that already affects over 300 million people worldwide," added Dr. White.
Neobiosis is a clinical-stage biopharmaceutical company pioneering the development of perinatal tissue-derived therapeutics, a new class of medicines with the potential to transform the treatment of a wide spectrum of diseases with high unmet medical needs. By leveraging the biology of birth tissues as a natural source of regenerative and immunomodulatory cells, matrix and exosomes, Neobiosis has developed its proprietary platform to augment the innate properties of homeostasis to create a portfolio of novel therapeutic candidates. Neobiosis is dedicated to transparency, safety and efficacy of all of its products developed under FDA oversight.