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Inventiva believes that lanifibranor’s moderate and balanced pan-PPAR binding profile contributes to the favorable tolerability profile that has been observed in clinical trials and pre-clinical studies to date.
Now we intend to evaluate safety, tolerability and preliminary antitumor activity of KO-2806 in a Phase 1 dose escalation study, which we're calling FIT-001.
Pharmacokinetics data dynamic biochemical changes and safety tolerability will serve as the basis for an end of Phase 2 meeting with FDA.
So, it will be very much a data-driven decision as we start to see how the -- what the PK looks like and what the tolerability is like.
This multi-center, open-label trial is intended to evaluate the safety, tolerability, pharmacokinetics antitumor activity and pharmacodynamics of 154 in combination with liposomal doxorubicin.
Unicycive Therapeutics notes that the FDA wants more info on risk assessment and clinical data to discern the tolerability of LDC in patients.
Source: https://investorplace.com/2023/06/why-is-unicycive-therapeutics-uncy-down-24-today/
We have demonstrated across multiple candidates in many clinical studies and in thousands of patients that our liver-directed candidates appear to achieve high levels of target engagement and have encouraging safety and tolerability profiles.
When added to existing psychostimulants, Qelbree demonstrated a favorable safety and tolerability profile as well as a significant improvement in ADHD symptoms in pediatric patients (6-17 years), regardless of timing of dosing.
With no additional safety or tolerability issues, the findings of the safety study and an earlier pharmacokinetic study will be submitted to the FDA in the course of this month.