Herantis Pharma Plc · OMXHEX:HRTIS
Herantis Pharma — Treat ER webinar (November 2020)
23 slides from Herantis Pharma's conference presentation, Nov 18, 2020
Slide 1: Renishaw Drug Delivery System (RDDS)
Renishaw Drug Delivery System (RDDS) Jim Baker Renishaw Neuro Solutions 18 November 2020 19/11/2020 1
Slide 2: Surgery and infusions
Surgery and infusions 19/11/2020 2
Slide 3: Content
Content • Primary Endpoints • • Secondary Endpoints • Exploratory Endpoint • Learning from trial and future steps 19/11/2020 3
Slide 4: Objectives of Drug Delivery Device
Objectives of Drug Delivery Device Primary objectives of this study were; • The safety of the drug delivery system • The accuracy of the drug delivery system Secondary objectives of this study were; • Port stability • Patency (did it remain ‘open’, lack of obstruction) Exploratory objective was • Ex
Slide 5: Primary endpoint - Safety
Primary endpoint - Safety • Adverse Device Events (ADE) An Adverse Device Event (ADE) is an Adverse Event related to the drug delivery device A Serious Adverse Device Event (SADE) is a • Serious Adverse Device Events (SADE) Serious Adverse Event related to the drug delivery device 19/11/2020 5
Slide 6: Primary endpoint - Safety
Primary endpoint - Safety Observed Adverse Events* profile 3% 3% 2% 3% 3% 3% 39 % 31 % 13 % Cardiac disorders General disorders and administration site conditions Injury, poisoning and procedural complications Central Nervous system disorders Psychiatric disorders Vascular disorders Eye disorders In
Slide 7: Primary endpoint - Safety
Primary endpoint - Safety 3% 3% 3% 3%3% 2% Central Nervous System Disorders (12) 39 % 31 % 13 % Small air bubble in brain, no symptoms, transient Suspected Epilepsy Blurred vision Headache 19/11/2020 7
Slide 8: Primary endpoint - Safety
Primary endpoint - Safety 3% 3% 3% 3%3% 2% General disorders and administration 39 % site conditions (15) 31 % 13 % Implant site reaction Impaired healing 19/11/2020 8
Slide 9: Primary endpoint - Safety
Primary endpoint - Safety 3% Injury, poisoning and procedural complications (5) 3%3% 3%2% 3% 39 % 31 % 13 % Small bleed in brain Fall 19/11/2020 9
Slide 10: Primary endpoint - Safety
Primary endpoint - Safety SADEs (whole trial) 17 % 16 % 17 % 33 % 17 % Confusion Infection around port Skin tissue decay (necrosis) around the port Brain abscess Wrist fracture after a fall on wet floor 19/11/2020 10
Slide 11: Primary Endpoint - Safety All SADEs recovered
Primary Endpoint - Safety Surgery First IMP dosing Extension study start Healing period 3 SADEs 1 SADE 2 SADEs 0 SADEs Wrist fracture after 0 SADEs Brain abscess fall on wet floor Confusion and Brain abscess Infection Both patients explanted Skin breakdown All SADEs recovered 19/11/2020 11
Slide 12: Primary endpoint - Accuracy
Primary endpoint - Accuracy Anatomical accuracy 100% catheters in Putamen Positional accuracy 64 out of 68 catheter tips within 3mm of planned target (94.1%) Average 1.5 mm 19/11/2020 12
Slide 13: Secondary Endpoints
Secondary Endpoints Patency (openness, lack of obstruction) 99.8% of catheters remained patent throughout the trial The stability of the transcutaneous port 100% of ports were stable throughout the trial 19/11/2020 13
Slide 14: Exploratory Endpoint - Distribution
Exploratory Endpoint - Distribution 04-Dec-2017 20-Dec-2017 19/11/2020 14 CONFIDENTIAL
Slide 15: Primary Endpoints and results; Learnings and future steps
Primary Endpoints and results Learnings and future steps 19/11/2020 15
Slide 16: Learnings and future steps
Learnings and future steps Holgers Grades (added up) vs. days since surgery Estimate of healing period for the port site 11 weeks • Holger grade of 0 to 4 at each visit • 0 = no skin reaction, 4 = worst reaction Healing time (Days) Average 11 weeks 19/11/2020 16
Slide 17: Learnings and future steps: Priming Aid
Learnings and future steps Priming Aid • Air bubbles • Improving priming (removal of air in lines) and usability 17 19/11/2020
Slide 18: Learnings and future steps: Port drape
Learnings and future steps Port drape • Help to keep hair out of the way during connection of the giving set • Help in keeping the port area generally cleaner during infusions 19/11/2020 18
Slide 19: Learnings and future steps
Learnings and future steps Process Guidance Software (PGS) Surgical Instrumentation improvements 19/11/2020 19
Slide 20: Learnings and future steps: Training Manual
Learnings and future steps Training Manual Includes • Port care chapter • Case studies • Better planning of port location • Importance of a ‘Clinical Microbiologist’ 19/11/2020 20
Slide 21: Learnings and future steps: Instructions For Use
Learnings and future steps Instructions For Use • Consideration on what to do if the skin is swollen during infusion • Cleaning regime of port before an infusion clarified and made more robust • Time between surgery and first infusion increased by one week • Port cap wearing updated to 12 hours on /
Slide 22: Conclusion
Conclusion • Trial proved the device is safe • Catheters hit the target • Learnings from trial implemented either within the trial or for future trials 19/11/2020 22
Slide 23: Thank you
Thank you 19/11/2020 ER AMMEN ounce bythe Hrizon 2020 programme RENISHAW.& - EEE tre European Union apply innovation