Pliant Therapeutics, Inc. · NASDAQ:PLRX
Pliant Therapeutics — ERS International Congress 2023
18 slides from Pliant Therapeutics's conference presentation, Sep 10, 2023
Slide 1: Safety, tolerability and antifibrotic activity of bexotegrast: Phase 2a INTEGRIS-IPF study
42463 Safety, tolerability and antifibrotic activity of bexotegrast: Phase 2a INTEGRIS-IPF study (NCT04396756) Wuyts WA, Valenzuela C, Jenkins G, Goldin JG, Kim GJ, Jurek M, Turner S, Decaris M, Barnes CN, Lefebvre É, Cosgrove G, Cottin V SEPTEMBER 10, 2023 © 2023 PLIANT THERAPEUTICS
Slide 2: Conflict of interest disclosure
Conflict of interest disclosure ❑ I have no real or perceived conflicts of interest that relate to this presentation. ✓ I have the following real or perceived conflicts of interest that relate to this presentation: ❑ Affiliation/Financial interest Commercial company Grants/research support: Roche, B
Slide 3: Disclaimers
Disclaimers This presentation has been prepared by Pliant Therapeutics, Inc. ("we," "us," "our," "Pliant" or the “Company”). The information set forth herein does not purport to be complete or to contain all of the information you may desire. Statements contained herein are made as of the date of th
Slide 4: αvβ6 and αvβ1 integrins drive cell-matrix interactions in fibrosis
αvβ6 and αvβ1 integrins drive cell-matrix interactions in fibrosis αvβ6 and αvβ1 integrins promote fibrosis • TGF-b is a central mediator of fibrosis1,2 through activation of TGF-β1,2 • Systemic TGF-b blockade carries toxicity risks2 Bexotegrast • Activation of latent TGF-b by αvβ6 (lung (PLN-74809)
Slide 5: Phase 2a INTEGRIS-IPF study – 12-week analyses
Phase 2a INTEGRIS-IPF study – 12-week analyses FVC change from Baseline to Week 12 • Bexotegrast was well tolerated across all dose (MMRM analysis) (efficacy mITT populationa) groups over 12 weeks of treatment; most TEAEs were mild to moderate in severity, with no drug- Bexotegrast 320 mg related SA
Slide 6: Aims and objectives
Aims and objectives To present Week 24 results from INTEGRIS-IPF (NCT04396756) for the safety, tolerability, and durability of effects on FVC and QLF of bexotegrast 320 mg in participants with IPF Purpose of evaluating longer term treatment with bexotegrast 320 mg • Safety and tolerability of the hi
Slide 7: INTEGRIS-IPF study design and endpoints
INTEGRIS-IPF study design and endpoints Bexotegrast Bexotegrast 40 mg (N=22) END OF STUDY Bexotegrast 80 mg (N=23) SCREENING 3:1 Randomization Bexotegrast 160 mg (N=22) Bexotegrast 320 mg (N=21) N=21 Pooled Placebo (N=31) N=8 Placebo Stratified for use of background therapy (Y/N) Day -28 Baseline We
Slide 8: Baseline demographics and disease characteristics – bexotegrast 320 mg cohort
Baseline demographics and disease characteristics – bexotegrast 320 mg cohort Participants, n (%) Bexotegrast 320 mg Placebo Demographics (N=22)a (N=8)a Male sex, n (%) 21 (95.5) 5 (62.5) Mean age, years (SD) 70.5 (7.14) 73.3 (7.98) Mean time since IPF diagnosis, months (SD) 34.4 (28.97) 41.6 (32.56
Slide 9: Safety summary—bexotegrast 320 mg cohort
Safety summary—bexotegrast 320 mg cohort Participants, n (%) Bexotegrast 320 mg Placebo Participants with any: (N=22)a (N=8)a TEAE 20 (90.9) 7 (87.5) TEAE related to study drug 5 (22.7) 2 (25.0) Grade ≥3 TEAEb 5 (22.7) 1 (12.5) Grade ≥3 TEAE related to study drug 1 (4.5)c 0 (0.0) SAE 2 (9.1) 1 (12
Slide 10: Most frequently reported TEAEs were not related to study drug – bexotegrast 320 mg cohort
Most frequently reported TEAEs were not related to study drug – bexotegrast 320 mg cohort Bexotegrast 320 mg Placebo AE, n (%) of Participants Reporting (N=22) (N=8) Most frequent TEAEs (>10% in at least one arm and n >1 participant) Diarrhea 7 (31.8) 3 (37.5) Related to study drug 4 (18.2) 0 Dysp
Slide 11: FVC change from Baseline to Week 24: ITT population and background therapy subgroup
FVC change from Baseline to Week 24 ITT population and background therapy subgroup ITT population Background therapy subgroup Bexotegrast reduced FVC decline Bexotegrast + a background therapy reduced by 67% relative to placebo at Week 24 FVC decline by 80% relative to a background therapy alone at
Slide 12: FVC change at Week 24: ITT population
FVC change at Week 24 ITT population FVC change data suggest a persistent treatment effect from 12 to 24 weeks with bexotegrast 320 mg Participants with missing data are not included here FVC, forced vital capacity; ITT, intent-to-treat © 2023 PLIANT THERAPEUTICS 12
Slide 13: Change in QLF score and stabilization/improvement in fibrosis
Change in QLF scorea change from Baseline and stabilization/improvement in fibrosis Per CT protocol populationb Change in QLF score Stabilization/improvement in fibrosis 100 QLF improved/stable or worsening QLFd 71% Proportion of participants with improved/stable from Baseline at Week 24 (%) 50 from
Slide 14: Conclusions and future research
Conclusions and future research Bexotegrast 320 mg was well tolerated in participants with IPF for up to 40 weeks of treatment • Most TEAEs were mild or moderate in severity • No discontinuations due to TEAEs occurred from Week 12 to Week 40 • No drug-related SAEs were reported There was evidence of
Slide 15: BEACON-IPF study design
BEACON-IPF study design PRIMARY ENDPOINT • Change from baseline in absolute FVC (mL) Randomization 1:1:1 at Week 52 END OF STUDY Placebo (n=89) SCREENING SECONDARY ENDPOINTS Bexotegrast 160 mg (n=89) • Time to disease progression (≥10% absolute decline from baseline Bexotegrast 320 mg (n=89) in FVCp
Slide 16: Acknowledgements
Acknowledgements • Thank you to the clinical site staff and the patients who participated in this study • The INTEGRIS-IPF study was sponsored by Pliant Therapeutics, Inc. • Thank you to Hardean E Achneck, MD (Senior Vice President, Head of Clinical Development at Pliant Therapeutics, Inc.) and Anni
Slide 17: References
References • Decaris ML, Schaub JR, Chen C, et al. Dual inhibition of αvβ6 and αvβ1 reduces fibrogenesis in lung tissue explants from patients with IPF. Respir Res 2021;22(1):265 • Horan GS, Wood S, Ona V, et al. Partial inhibition of integrin alpha(v)beta6 prevents pulmonary fibrosis without exacer
Slide 18: Please use the QR codes shown to download a copy of the ePoster
Please use the QR codes shown to download a copy of the ePoster (OA1423) pliantrx.com live.ersnet.org The ERS is not responsible for and does not endorse the data and information presented on external sites © 2023 PLIANT THERAPEUTICS
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