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FB-101

Development stage
Phase 1
Lead developer
1ST Biotherapeutics
Modality
Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Small Molecules, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
Administration
Oral, Vaginal
01

Overview

FB-101 refers to two distinct investigational drugs in clinical development by different companies for unrelated indications: **1. FB-101 (1ST Biotherapeutics/Neuraly):** A small molecule c-Abl (Abelson tyrosine kinase) inhibitor being developed primarily for neurodegenerative diseases such as Parkinson's disease and amyotrophic lateral sclerosis (ALS). The drug is designed to block the activity of c-Abl, a protein implicated in the toxic buildup of alpha-synuclein aggregates in the brain—a hallmark of Parkinson’s pathology. Preclinical and early clinical data indicate that FB-101 crosses the blood-brain barrier and is well-tolerated in healthy volunteers[1][2][4][5]. It may also have activity against LRRK2 (Leucine-rich repeat serine/threonine-protein kinase 2), another target relevant to neurodegeneration[2]. **2. FB101 (Freya Biosciences):** A vaginal microbial immunotherapeutic developed by Freya Biosciences for women’s health indications, specifically targeting vaginal dysbiosis and potentially improving fertility outcomes such as IVF implantation success. This formulation consists of live Lactobacillus species intended to restore a healthy vaginal microbiome when administered intravaginally. Phase 1 results showed rapid resolution of dysbiosis with sustained engraftment of beneficial bacteria[6][9].

Other names
FB-101FB101FB 101
02

Targets

ABL1 (ABL proto-oncogene 1, non-receptor tyrosine kinase)LRRK2 (Leucine-rich repeat serine/threonine-protein kinase 2)

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