Preclinical Safety Studies of Experimental Medicines

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1 AOQ-Qld RRDM seminar 2 July 2008 Preclinical Safety Studies of Experimental Medicines Brian Creese

2 Introduction Seminar Outline Preclinical safety data requirements for phase 1 trials Dose selection for phase 1 trials Phase 0 trials Preclinical data requirements for later stage clinical trials and product registration

3 Drug Development Time-consuming process Requires integrated approach (CMC, preclinical, clinical, regulatory)

4

5 Preclinical Development Efficacy studies (non-glp) In vitro studies Animal disease models Mechanism of action studies Safety studies (GLP) Safety pharmacology Pharmacokinetics and metabolism Local tolerability General toxicity (single and repeated-dose) Genetic toxicity Carcinogenicity Reproductive and developmental toxicity

6 Value of Preclinical Safety Studies Dose selection in phase 1 clinical trials Based on NOAEL in preclinical safety studies Information on likely side effects Minimise risk of serious AEs in clinical trials Histopathological assessment Identifies potential target organs Toxicity endpoints not amenable to clinical investigation Carcinogenicity Genetic toxicity Reproductive toxicity

7 Aims of Preclinical Safety Studies Identification of target organs for toxicities Characterisation of dose-response relationships Determination of no-effect levels for toxicity Relationship of toxic effects to exposure Potential reversibility Mechanisms of toxicity

8 Global Harmonisation of Preclinical Study Requirements International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Government and industry representatives from USA, Europe and Japan First meeting in 1990, on-going process

9 ICH Guidelines for Preclinical Safety Testing S1 Carcinogenicity (S1A, S1B, S1C and S1C(R2)) S2 Genotoxicity (S2A and S2B, now combined into S2(R1)) S3 Toxicokinetics (S3A) and pharmacokinetics (S3B) S4 Repeated-dose toxicity (S4A) S5 Reproductive toxicity (S5A and S5B, now combined as S5(R2)) S6 Biotechnology Products S7 Safety pharmacology (S7A and S7B) S8 Immunotoxicology M3(R1) Timing of preclinical studies in relation to clinical trials

10 Preclinical Safety Studies Prior to Phase 1 Trials Safety pharmacology Toxicokinetics, pharmacokinetics and metabolism Local tolerability Acute (single-dose) toxicity Repeated-dose toxicity Genetic toxicology Effects on embryofetal development

11 Safety Pharmacology Effects on physiological systems unrelated to desired activity (i.e. unwanted effects or side-effects) Screening at high dose levels GLP compliance is required Core battery: Central nervous system Respiratory system Cardiovascular system (including QT prolongation) ICH guidelines S7A and S7B

12 Pharmacokinetics and Toxicokinetics Pharmacokinetics Absorption, distribution, metabolism and excretion Characterisation of basic pharmacokinetic parameters Doses associated with pharmacological activity Usually single-dose Toxicokinetics Assessment of systemic exposure (blood levels) in animal toxicity studies (C max and AUC) High doses, repeated dosing Same species as used in toxicity studies Usually an integral part of the toxicity study

13 Toxicokinetics Exposure data in animals should be evaluated prior to human clinical trials (ICH guideline M3) Objectives: Describe systemic exposure in animals Relationship to dose and duration of dosing Relationship between exposure and toxicity Assess clinical relevance of toxicity findings Support choice of species and treatment regimen in preclinical safety studies (ICH guideline S3A)

14 Pharmacokinetics ICH guideline M3: Further information on absorption, distribution, metabolism and excretion in animals should be made available to compare human and animal metabolic pathways. Appropriate information should usually be available by the time the Phase I (Human Pharmacology) studies have been completed.

15 Pharmacokinetics Basic pharmacokinetic studies are usually completed before phase I clinical trials In vitro studies on drug metabolism to support species selection for toxicity studies Information on plasma kinetics to determine dose frequency and toxicokinetic sampling times Understanding pharmacodynamic properties of the drug and preparation of the clinical development plan

16 Local Tolerability The evaluation of local tolerance should be performed prior to human exposure (ICH guideline M3) Animal studies using routes and formulation applicable to proposed human administration May be part of other toxicity studies

17 Acute (Single-Dose) Toxicity ICH guideline M3: The single dose (acute) toxicity for a pharmaceutical should be evaluated in two mammalian species prior to the first human exposure (Note 1). A dose escalation study is considered an acceptable alternative to the single dose design. Note 1: Refer to ICH-1 and regional guidelines ICH-1 (1991): LD 50 determination should be abandoned for pharmaceutical products

18 Acute Toxicity: Regional Guidelines EU USA Japan Species 2* 2 (one nonrodent) # 2 (one nonrodent) # Routes 2** 2** 1 (clinical) Days of observation * Usually mouse and rat ** Clinical route + maximum systemic exposure (IV) # Dose escalation is acceptable study design for non-rodents

19 Acute Toxicity: Changes Are Afoot Sep ICH concept paper M3(R2) The need to keep single dose toxicity studies as a fixed requirement prior to first human exposure. Nov Acute Toxicity Workshop May 2007 NC3Rs workshop report Mar Robinson et al (Reg Tox Pharmacol 50: )

20 Robinson et al (2008) A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development 18 European companies Evidence-based review 74 compounds Conclusion: Acute toxicity studies are not needed prior to first clinical trials in humans. Instead, information can be obtained from other studies, which are performed at more relevant doses for humans and are already an integral part of drug development. The conclusions have been discussed and agreed with representatives of regulatory bodies from the US, Japan and Europe.

21 Repeated-Dose Toxicity Repeated-dose toxicity studies in two mammalian species (including one non-rodent) are required to support all clinical trials (except phase 0 ) Recommended duration of repeated-dose toxicity studies is related to: Duration of proposed clinical trial Therapeutic indication Scale of the proposed trial (ICH guideline M3)

22 Duration of Repeated-Dose Toxicity Studies Equal to or longer than the duration of the proposed clinical trial (up to maximum of 6-9 months) Exception: where significant therapeutic gain has been shown, trials may be extended beyond the duration of supportive repeated dose toxicity studies on a case by case basis (ICH guideline M3)

23 Duration of Repeated-Dose Studies for Phase 1 Trials Trial duration Single dose Up to 2 weeks Up to 1 month Up to 3 months Up to 6 months > 6 months Minimum duration of animal study Rodent Non-rodent 2 weeks 2 weeks 2 weeks 2 weeks 1 month 1 month 3 months 3 months 6 months 6 months 6 months Chronic (9 mo)

24 Genetic Toxicity ICH M3 guideline: Prior to first human exposure, in vitro tests for the evaluation of mutations and chromosomal damage are generally needed ICH guideline S2(R1): Bacterial reverse gene mutation assay (Ames test) Test for chromosomal damage in mammalian cells (in vitro or in vivo) Exception: biotechnology products (ICH-S6)

25 Reproductive and Developmental Toxicity Dependent on population used in the trial: Phase 1 trials usually done in healthy males Women not of childbearing potential may also be included Women of childbearing potential (WOBCP) not usually included in early phase trials because of high level of concern regarding potential hazards associated with unintentional exposure of an embryo or fetus Regional variation in requirements for inclusion of WOCBP

26 Inclusion of Women of Child-Bearing Potential in Clinical Trials Europe and Japan (and Australia) WOCBP may be included following completion of embryofetal development studies in two species USA WOCBP may be included in early, carefully monitored studies provided appropriate precautions are taken to minimise risk (ICH M3 guideline)

27 Inclusion of WOCBP Conditions for including women of childbearing potential before developmental toxicity studies are completed (USA only): Pregnancy testing Highly effective method of birth control Entry after a confirmed menstrual period Continued testing and monitoring during the trial Informed consent must include pertinent information from related pharmaceuticals and statement of risk

28 Embryofetal Development Studies ICH guideline S5(R2): Two mammalian species (usually rats and rabbits) Dosing during organogenesis (days 6-16 in rats) Fetuses examined one day prior to parturition Endpoints include: Toxic effects in pregnant animals Embryofetal deaths Fetal growth Structural changes

29 Starting Dose in Phase 1 Trials FDA guidance document (July 2005): Based on no observed adverse effect level (NOAEL) NOAEL in each animal species converted to human equivalent dose (HED) Conversion usually based on body surface area (dose mg/m 2 ) Most appropriate animal species Usually the most sensitive, based on lowest HED Application of safety factor 10 is default value Comparison with pharmacologically active dose Based on pharmacodynamic modelling

30 Phase 0 Clinical Trials Special guidelines in Europe and USA Less stringent preclinical requirements allow early start of clinical development program Europe (and Australia) Non-clinical Safety Studies to Support Clinical Trials with a Single Microdose (June 2004). USA: Exploratory IND Studies guidance document (Jan 2006) Identified as an issue in ICH M3(R2) concept paper

31 Microdose Studies (Europe) Single dose only Microdose defined as 1/100 th of anticipated dose for pharmacological effect Maximum dose of 100 µg (0.1 mg) Endpoints: Pharmacokinetics and distribution Pharmacodynamic (receptor selectivity) Sensitive analytical techniques (PET, AMS) Suitable for comparative studies of multiple therapeutic candidates

32 Exploratory IND studies (USA) Prior to traditional phase 1 IND studies Limited duration of exposure (single-dose or up to 7 days) No therapeutic or diagnostic intent Usually in healthy volunteers Study endpoints: Mechanism of action or pharmacodynamics Pharmacokinetic profile or biodistribution May include dose escalation studies with pharmacodynamic endpoint (i.e. not MTD)

33 Phase 2 Clinical Trials Additional preclinical studies will depend on design of phase 2 trials: More detailed information on preclinical pharmacokinetics Additional data on local tolerability may be required Repeated-dose toxicity studies of longer duration may also be required Genetic toxicity testing in vivo Reproductive toxicity studies (depending on geographical location and patient selection criteria) Immunotoxicity testing may be required (ICH guideline S8).

34 Phase 3 Clinical Trials Effects on fertility males and females one species, usually rats In Europe (and Australia), guidelines for duration of repeated-dose toxicity studies to support phase 3 trials are more stringent

35 Duration of Repeated-Dose Studies for Phase 3 Trials in Europe (and Australia) Trial duration Up to 2 weeks Up to 1 month Up to 3 months > 3 months Minimum duration of animal study Rodent Non-rodent 1 month 1 month 3 months 3 months 6 months 3 months 6 months Chronic (9 mo)

36 Additional Preclinical Studies to Support Marketing (Registration) Long-term ( chronic ) toxicity studies are required if clinical use is likely to exceed one month 6 months in rodents 9 months in non-rodents (FDA may require 12 months) Complete assessment of effects on reproduction and development Carcinogenicity studies in two species if cumulative lifetime exposure is > 6 months ICH guidelines S1A

37 SUMMARY Extent of preclinical safety testing is dependent on: Stage of development Duration of human exposure Target population Basic package of preclinical safety studies for phase 1 trials Reduced preclinical requirements for phase 0 trials Preclinical safety testing continues during clinical development

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