Slide 1: PCS12852, A Novel 5-HT4 Agonist, Improves GCSI Symptom Scores and Gastric Emptying in Gastroparesis Patients
PCS12852, A NOVEL 5-HT4 AGONIST, IMPROVES GCSI SYMPTOM SCORES AND GASTRIC EMPTYING IN GASTROPARESIS PATIENTS Das, Maya; Smythe-Peterkin, Shanique; McCallum, Richard W.; Parks, Kayla; Franks, Peter; Young, David; Bigora, Sian @ Processa Pharmaceuticals
Slide 2: Author and Disclosures
Author and Disclosures * Maya Das, MD, JD * Kayla Parks * Heliconia West, LLC, CA * Processa Pharmaceuticals * Processa Pharmaceuticals (employee) (consultant) * Peter Franks * Shanique Smythe-Peterkin * Processa Pharmaceuticals * Processa Pharmaceuticals (employee) (employee) * David Young, PharmD,
Slide 3: Abstract
Abstract + INTRODUCTION: Gastroparesis is a chronic disorder characterized by delayed gastric emptying of solid food in the absence of a mechanical obstruction and is a condition with unmet needs due to the limited available treatment options for patients. This study investigated the effects of PCS1
Slide 4: Background
Background * PCS12852, a new 5-HT4 receptor agonist * Superior potency and efficacy in animals and humans * High selectivity for 5-HT4 receptors with no evidence of cardiac toxicity * Excellent safety and tolerability profile in nonclinical and Phase 1 studies * Currently being investigated for the
Slide 5: 2A: Proof of Concept Study Design
Phase 2A: Proof of Concept Study Design A Phase 2A, Placebo-controlled, Randomized, Dose Response Study of the Safety, Pharmacokinetics and Efficacy of PCS12852 on Gastric Emptying Rate Assessed by °C Spirulina GEBT in Patients with Moderate to Severe Gastroparesis J doubie-biind Treatment Period I
Slide 6: Patient and Disease Characteristics
Patient and Disease Characteristics Characte! PCS12852 0.1m (N=9) Age (Yrs :MeantSD) Sex (M:F) Height (cm: Mean+SD) Weight(kg: Mean+SD) BMI (kg/m?2:Mean+SD) Time Since Diagnosis (Yrs :Mean+SD) Type of Gastroparesis (IG:DG) @ Processa Pharmaceuticals 58.6£7.3 2:7 163.046.8 80.7414.1 30.545.8 5.042.8
Slide 7: 2A Study: GEBT Results
Phase 2A Study: GEBT Results 13C-Spirulina GEBT Data: Changes from Baseline to Day 28 Mean GEBT GP-01 Study Ed Parameter** (SD) [5cs398520.1 me | PCS128520. (n=9) 6) teo (minutes) -7.4#20.2 -31.9.450.57 -9.4+42.4 AUC 632.741881.5 597.142635.8 37.4#2022.8 thy (minutes) 2,444.7 -9.7413.7* -7.827.2" *
Slide 8: 2a Study: GEBT Results Mean GEBT (kPCD) vs Time
Phase 2a Study: GEBT Results 60 Mean GEBT (kPCD) vs Time 50 40 --@--0.1 mg Baseline © 0.1mg Day 28, 20 ~-#--0.5 mg Baseline a 0.5mg Day 28, 10 =-8--Placebo Baseline —@— Placebo Day 28 0 50 100 150 200 250 Time (minutes) @ Process Pharmaceuticals Confident! | January 2023s
Slide 9: GEBT Results: Mean Change from Baseline
nen cn ccc Phase 2a Study: GEBT Results Mean Change from Baseline for GEBT (kPCD) 15 10 0 50 100 150 200 250 Change from Baseline kPCD (%) ° Time (minutes) —-0.1mg —t-0.5mg -e-Placebo @ Process Pharmaceuticals Conon |runy 2003.
Slide 10: 2a Study: Efficacy Results — Change from Baseline for Total GCSI Score at Day 28
Phase 2a Study: Efficacy Results — Change from Baseline for Total GCSI Score at Day 28 Mean Change from Baseline for Total AMNS-GCSI-DD Score Day of Study —@-0.1 mg PCS12852 —e-0.5 mg PCS12852_ -®-Placebo @ Process Pharmaceuticals DOW May6,2023 10
Slide 11: 2a Study: Efficacy Results- Responders Assessment
Phase 2a Study: Efficacy Results- Responders Assessment Proportion of Patients with a Clinically Meaningful (>0.5) Reduction from Baseline to Day 28 in 120 ANMS-GCSI-DD Total Score m0.1mgPCS12852 mM Placebo 0.5 mg PCS12852 100.0 100 83.3 » 80 s 5 60 57.1 = 50.0 2 = 40 375 20 7 16.7 0 | | All patient
Slide 12: 2a Study: Efficacy Results - AMNS-GCSI-DD Subscores
Phase 2a Study: Efficacy Results - AMNS-GCSI-DD Subscores Mean Change from Baseline for AMNS-GCSI-DD * For the 0.5 mg PCS12852 group Vomiting frequen oy compared to placebo, greater improvements were noted in 4 of the 5 subscores — vomiting, nausea, abdominal pain and feeling excessively full. equen
Slide 13: 2a Study: Safety Results
Phase 2a Study: Safety Results ¢ A total of 12 Treatment Emergent Adverse Events (TEAEs) occurred in 6 subjects, all in the 0.5 mg PCS12852 group ¢ All TEAEs were either mild or moderate, with no severe cases, and resolved without sequelae * AEs were the following: * Diarrhea (5) * GERD (1) Abdomina
Slide 14: 2A: Pharmacokinetic Results
Phase 2A: Pharmacokinetic Results Mean (+SD) PCS12852 0.1 mg PCS12852 0.5 mg Pharmacokinetic Parameters Day 1 Day 28 Day 1 Day 28 Cmax (ng/ml) 0.12+0.04 0.11+0.69 0.59+0.33 0.4840.26 Tmax (h) 2.58+0.95 3.3242.07 2.104144 3.3542.06 AUC(0-last) (h*ng/mL) 0.6340.28 1.1041.23 3,0641.59 7.A247.11 t% (h)
Slide 15: 2a: Summary
Phase 2a: Summary * GEBT results demonstrated a significant improvement in gastric emptying in patients receiving 0.5 mg of PCS12852 * PCS12852 0.5 mg administered daily over 28 days in gastroparesis patients successfully improved gastroparesis symptoms in a clinically meaningful way as defined by >
Slide 16: Questions?
QUESTIONS?