On Demand, Behaviorally-Congruent Rectal Microbicide Douche
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1 On Demand, Behaviorally-Congruent Rectal Microbicide Douche Craig W. Hendrix, MD Johns Hopkins University MTN Annual Meeting 2018
2 Outline Describe need for rectal microbicides Limitations to daily oral PrEP Limitations to on demand rectal gel applicator Discuss microbicide douche development Community demand/readiness (next up - Alex!) Vehicle development Clinical Development NHP SHIV challenge proof-of-concept
3 Rectal Microbicide Feasibility Oral PrEP not for everyone Product options improve adherence On demand oral TDF/FTC & vaginal PrEP efficacious; rectal gel high adherence Behaviorally-congruent ARV formulations piggy-back onto commonly used sex products
4 Rectal Microbicide Development Are rectal douches acceptable to those at risk? Can ARVs be delivered safely by rectal douche? Can douches provide protective concentrations? Can a rectal douche prevent HIV?
5 Enema Vehicle Selection Toxicity Distribution Acceptability ISO HYPER ISO MIP Coronal SPECT/CT 9 men, single dose cross-over Hyper-, iso-, hypo-osmolar enema Luminal PK, histology, acceptability favor iso-osmolar Leyva, et al. ARHR 2013
6 Rectal Distribution: Microbicide & HIV Microbicide ( 111 In-DTPA) HIV ( 99m Tc-SC) in Ejaculate Rectal TFV gel (0h), simulated sex/ejaculation (1h), SPECT/CT (2h) Hiruy, et al. ARHR 2015
7 Speeding Tissue Absorption Iso Hypo Osmolarity Administered in isotonic (iso) or hypotonic (hypo) solution Fluorescent particle distribution mouse vagina 10 post-dose Vaginal mucosal surface coverage varies with osmolality Ensign, et al., Biomaterials 2013 & Sci Trans Med 2012
8 DREAM Program Background Adherence & choice greatest PrEP needs On demand, behaviorally congruent widely desired Enema behaviorally-congruent (67-75% RAI MSM) Objectives Single dose TFV (prodrug) enema, 1 week protection Process Sequential mice, macaque, human Select best of TFV, TDF, TAF, CMX-157 Optimize formulation, osmolality, nano, gelling
9 Interspecies TFV-DP Comparisons Interspecies comparisons Hypo-osmolar >5x increases in tissue TFV-DP in macaques Significant variability (1log 10 range common) Target concentrations achieved by median low, exceeded by high doses Xiao et al AAC 2017
10 Macaque Explant Protection Time Product B TFV 5.28 mg/ml Iso-osmolar Product C TFV 5.28 mg/ml Hypo-osmolar 1 hr 24 hrs 72 hrs
11 DREAM-01 FIH Study Design: Phase I, single ascending dose study Goal: Identify dose achieving colon cell [TFV-DP] target Objectives: Safety, PK, PD (explant), & Acceptability Products (125 ml): A: TFV 1.76 mg/ml (normal saline) B: TFV 5.28 mg/ml (normal saline) C: TFV 5.28 mg/ml (half-normal saline) Subjects: 18 MSM receive all 3 products sequentially Outcomes: Safety: AEs, histology PK: (intense) blood, (sparse), colorectal tissue, rectal fluid Explore: colon proteomics & metabolomics, microbiome
12 Safety AE: None > Grade 2 Total Product A Participants who experienced an AE Product B Grade Grade Total Total # of AE s Reported Grade Grade Total Product Histology: No Change from Baseline Time Overall Grade (0-5) Epithelial Denudation (0-3) Lamina propria Hemorrhage (0-3) Baseline Pre-Dose Product A 1 or 3 hrs hrs hrs Product B 1 or 3 hrs hrs hrs Product C not shown No AE > Grade 2 product related, histology no change from baseline
13 Colonic Luminal Distribution Desired Colon Luminal Coverage J001 J002 J003 J004 Product A 1 hr Product B
14 Plasma TFV & PBMC TFV-DP PK Low Systemic Exposure Product A 220 mg/125 ml 0.9% NaCl Product B 660 mg/125 ml 0.9% NaCl Product C 660 mg/125 ml 0.45% NaCL Plasma Tenofovir (ng/ml) Hours
15 DREAM-01 Colorectal Tissue PK Very High Colon Tissue Cell TFV-DP
16 NHP Oral TDF v. TFV Douche PD Weekly intrarectal 10 3 TCID50 R5 SHIV Weekly plasma viral RNA by qpcr Hypo-Osmolar 2 vrna values > 250/mL x 2 wks = infected Iso-Osmolar IP/CP-HTM DREAM U19, Francois Villinger, Univ Louisiana (Lafayette) CROI LB 2018
17 NHP Oral TDF v. TFV Douche PK Plasma TFV concentrations similar Colorectal tissue TFV-DP far higher with rectal dosing (not steady-state) Steady-state oral TDF NHP studies underway Francois Villinger, Univ Louisiana (Lafayette) CROI LB 2018
18 DREAM-01 Data to Come Proteomics (Adam Burgener) Metabolomics (Anne Le) Microbiome (Jaques Ravel) Acceptability (Alex Carballo- Dieguez & Rebecca Giguere) DREAM Grindr Survey (on deck)
19 Summary New methods developed to enable development Complex early studies informed development DREAM Pre-Clinical Hypo-osmolar formulations increase tissue TFV-DP Douche better than oral in NHP SHIV challenge DREAM-01 Clinical ~85% complete, no safety signal TFV-DP colon target exceeded by 2-3log 10 in 1-3 hrs Plasma TFV below & colon TFV-DP above NHP
20 Acknowledgements NIH/DAIDS IP/CP-HTM Program Jim Turpin, Hans Spiegel, Jeanna Piper, Cherlynn Mathias, James Cummins, Anabel Lowry Johns Hopkins Mark Marzinke, Namandje Bumpus, Edward Fuchs, Ethel Weld, Rahul Bakshi Laura Ensign, Justin Hanes, Richard Cone Univ Pittsburgh Lisa Rowan, Ian McGowan, Ken Ho, Lin Wang, Cindy Jacobsen, Jarrett Engstrom, Rhonda Brand UCLA Peter Anton, Julie Elliott, Terry Sanders Columbia Alex Carballo-Dieguez, Rebecca Giguere Univ Louisville (Fayette) Francois Villinger, Xiao Peng Emory Sanjeev Gumber Duke David Katz CONRAD Tim McCormack Study Volunteers SAB Jim Pickett Tom Moench Florian Hladik Jose Romero Rada Savic
21 Thank You!
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