Investor Presentaiton
IDE161 Demonstrates Favorable Safety Profile in Preclinical Studies
Non-Clinical Pharmacology and Toxicology Studies Support Clinical Evaluation
IDE161 Differentiates versus PARPI in Nonclinical Safety Studies
PARP inhibition causes myelosuppression in rat and dog at clinically relevant systemic exposures
In contrast, IDE161 does not alter hematology parameters in rodents at relevant exposures
associated with the estimated therapeutic dose
% change from vehicle control
IDE161 versus PARPI in Rat Studies *
Niraparib
Olaparib
Talazoparib
IDE161
•
IDE161 well tolerated
preclinically with tumor
regressions observed at
doses below mouse MTD
•
Human efficacious dose
IDE161 Drug Product
TT
-20-
-60-
,
RBC
MOC NEU MBE MEU ROC NEU MOC NEU
RBC
Hematology Parameter
* PARPI data extracted from repeat dose toxicology data presented in NDA reviews ([email protected]) and
prescribing labels. Species chosen for data illustration (rat) was based on availability of data at a dose level that
most closely approximated systemic exposure (AUC) associated with the clinically recommended dose.
projection based on
maximum efficacious dose in
mouse (100 mg/kg/day)
which covers cellular IC for
≥ 22 hours
Data from GLP toxicology
studies support a proposed
safe starting dose of 0.5X the
estimated therapeutic dose
IDE161 API synthetic process
and drug product tablet
formulation developed
IDEA A
BIOSCIENCES
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