FB418 / 1ST Bio - LARVOL DELTA

A Phase 1, SAD and MAD Study to Evaluate the Safety and Tolerability of FB418 (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: 1ST Biotherapeutics, Inc. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Sep 2024 ➔ Dec 2024

Enrollment open • Trial primary completion date • Amyotrophic Lateral Sclerosis • CNS Disorders • Movement Disorders • Parkinson's Disease • Psychiatry

A Phase 1, SAD and MAD Study to Evaluate the Safety and Tolerability of FB418 (clinicaltrials.gov) - P1 | N=64 | Not yet recruiting | Sponsor: 1ST Biotherapeutics, Inc.

New P1 trial • Amyotrophic Lateral Sclerosis • CNS Disorders • Movement Disorders • Parkinson's Disease • Psychiatry

1ST Biotherapeutics, Inc., Announces Positive Phase I Data of c-Abl Inhibitor in Neurodegeneration (GlobeNewswire) - P1 | N=24 | NCT04165837 | Sponsor: 1ST Biotherapeutics, Inc. | "1ST Biotherapeutics, Inc...announced a successful completion of its Phase I single ascending dose (SAD) study of FB-101 in healthy adult subjects. The SAD portion of the Phase I clinical trial of FB-101 was completed in Baltimore, MD, USA, and demonstrated that oral administration of FB-101 was well-tolerated across all cohorts with favorable safety results. No clinically significant findings were observed on safety measures including laboratory findings, vital signs, and ECGs at any dose. With FDA’s authorization, 1ST Biotherapeutics is planning on commencing the multiple ascending dose (MAD) portion of the Phase I study by the end of 2022....A subsequent Parkinson’s drug candidate called FB418, a dual inhibitor of c-Abl and LRRK2, will be entering a Phase I clinical study in the first half of 2023."

New P1 trial • P1 data • Trial status • CNS Disorders • Parkinson's Disease

First Bio, US patent registration for ’FB418, a candidate substance for degenerative brain disease’ [Google translation] (Yakup Shinmoon) - "First Biotherapeutics...announced that it has obtained material approval for 'FB418', a candidate substance for the treatment of degenerative brain diseases such as Lou Gehrig's disease, Parkinson's disease, and Alzheimer's....The patents acquired this time have been registered with the U.S. Patent and Trademark Office as of August 24, 2021....'The company also holds 100% of the patent rights for FB418, and it is developing simultaneously with FB-101, which is currently undergoing clinical trials...'"

Patent • Alzheimer's Disease • CNS Disorders • Parkinson's Disease