The US Food and Drug Administration (FDA) has approved Neobiosis’ investigational new drug (IND) application for ViXome to treat post-Covid-19 syndrome (also known as long Covid).
ViXome is an acellular product derived from amniotic fluid.
It comprises a heterogeneous population of growth factors, exosomes, cytokines, microRNAs and chemokines.
In pre-clinical testing, the therapy showed potent immunomodulatory and pro-reparative effects.
Neobiosis chief scientific officer and CEO Dr Ian White stated: “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 [Caesarean delivery] of full-term pregnancies, into clinical development.
“We are eager to confirm our preclinical data in the clinic and expect to begin enrolling patients in Phase I during the second quarter of 2024.”
The company stated that the Phase I/IIa trial will thoroughly evaluate the therapy’s clinical efficacy and safety.
It developed perinatal tissue-derived therapeutics to transform a broad spectrum of diseases treatment of high unmet medical needs.
The company’s products are processed in advanced FDA-inspected, FDA-registered, cGMP (current good manufacturing process)-compliant cleanrooms in Gainesville, Florida, US.
Its research and development activities are performed at the University of Florida’s Sid Martin Innovate Biotechnology Institute in Alachua, Florida.
Dr White added: “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.”
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