TQS-168 / Tranquis Therapeutics - LARVOL DELTA

A randomized, placebo-controlled first-in-human study of oral TQS-168 in healthy volunteers: Assessment of safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect. (PubMed, Clin Transl Sci) - "TQS-168 was considered to be safe and generally well tolerated following single and multiple oral doses. The SDD formulation was selected for future patient studies."

Clinical • Journal • P1 data • PK/PD data • Amyotrophic Lateral Sclerosis • CNS Disorders

"Tranquis Therapeutics to Present Preclinical Data on TQS-168 at ARDD 2022 https://t.co/HSu7Ccyk79" (@NewsFromBW)

Preclinical

Tranquis Therapeutics Granted FDA Orphan Drug Designation for TQS-168 for the Treatment of Amyotrophic Lateral Sclerosis (Businesswire) - “Tranquis Therapeutics, Inc…announced the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for TQS-168, a small molecule modulator of PGC-1a, for the treatment of amyotrophic lateral sclerosis (ALS). ALS is a devastating disease with a high unmet need. Tranquis expects to begin a Phase 2 study of TQS-168 in people living with ALS by the end of 2022.”

New P2 trial • Orphan drug • Amyotrophic Lateral Sclerosis • CNS Disorders

The small molecule myeloid cell modulator TQS-168 normalizes the inflammatory phenotype of immune cells from ALS patients and extends survival in the SOD1 G93A ALS mouse model (Neuroscience 2021) - "The small molecule TQS-168 regulates the inflammatory phenotype of myeloid cells in patients with ALS and slows disease progression in a mouse model of ALS. Modulation of cytokines by TQS-168 correlated with survival in SOD1 G93A mice. TQS-168 will enter clinical development to evaluate its potential as a treatment for ALS patients."

Preclinical • Amyotrophic Lateral Sclerosis • CNS Disorders

Tranquis Therapeutics Announces Initiation of Phase 1 Study of TQS-168 (Businesswire) - "TQS-168 modulates myeloid immune cells through upregulation of PGC1a, representing a potential new class of treatment for ALS and other neurodegenerative diseases....Tranquis Therapeutics...today announced the initiation of dosing in a Phase 1 clinical study of TQS-168 in healthy volunteers....We look forward to moving TQS-168 into a Phase 2 study in the near-term.'....This Phase 1 clinical trial is being conducted in the United Kingdom and is expected to enroll 68 healthy volunteers."

New P1 trial • Amyotrophic Lateral Sclerosis • CNS Disorders