Priavoid A life without dementia Company Presentation, BIO, June, - - PowerPoint PPT Presentation

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Feb 14, 2024 536 likes •703 views

Priavoid A life without dementia Company Presentation, BIO, June, 2017 Prof. Dr. Dieter Willbold (co-founder and future Chairman of the Supervisory Board) The Company At a glance Established: probably in July 2017 Location: Jlich, Germany

SLIDE 1

Company Presentation, BIO, June, 2017

Priavoid

A life without dementia

Prof. Dr. Dieter Willbold

(co-founder and future Chairman of the Supervisory Board)

SLIDE 2

The Company

At a glance

Established: probably in July 2017 Location: Jülich, Germany (60 km from Düsseldorf) Parent Organizations: Research Center Jülich (FZJ) and Heinrich Heine University Düsseldorf (HHU) Pre-seed Funding Sources: FZJ, Helmholtz Association, HHU, Volkswagen Foundation

SLIDE 3

Our Vision

A life without dementia

➔ We want to stop Alzheimer’s disease using a new treatment strategy that employs a new class of orally available compounds. ➔ In parallel, this new strategy is also applied to

ther neurodegenerative diseases.

SLIDE 4

Alzheimer’s Disease

Registered drugs address only symptoms and have severe side effects

Generic Name Brand Name Approved Side Effects

Donepezil Aricept

All stages Nausea, vomiting, loss of appetite and increased frequency of bowel movements

Galantamine Razadyne

Mild to moderate AD Nausea, vomiting, loss of appetite and increased frequency of bowel movements

Memantine Namenda

Moderate to severe AD Headache, constipation, confusion and dizziness

Rivastigmine Exelon

Mild to moderate AD Nausea, vomiting, loss of appetite and increased frequency of bowel movements

Memantine + Donepezil Namzaric

Moderate to severe AD Headache, diarrhea, dizziness, loss of appetite, vomiting, nausea, and bruising

SLIDE 5

Intervention Strategies

Up to now, no disease modifying drug has been approved Monoclonal an(bodies binding to Aβ Aβ oligomer (toxic) Aβ fibril Aβ monomer APP beta and gamma secretase inhibitors

SLIDE 6

Intervention Strategies

Our strategy is to directly eliminate cytotoxic Aβ oligomers

PRI-002

(all-D-enan(omeric pep(de) Aβ oligomer (toxic) Aβ fibril Aβ monomer APP

SLIDE 7

Primary Pharmacodynamics - in vitro

QIAD: Quantitative determination of interference with Aβ aggregate size distribution PRI-002 eliminates toxic Aβ oligomers

Aβ

ligomer

(toxic) QIAD assay ( QIAD assay (Brener Brener et al., Scienti et al., Scientifj fjc Reports, 2015) c Reports, 2015)

SLIDE 8

Primary Pharmacodynamics

Most important results

Eliminates oligomers (QIAD)

Improves spatial learning and cognition after oral treatment (Morris water maze test, two mouse models)

Deceleration of neurodegenerative progression (SHIRPA test, third mouse model)

SLIDE 9

Pharmacokinetics and Toxicology

Overview of studies

Study type Test system / administration Pharmacokinetic studies In rodents in vivo, rats, i.v., p.o. In non-rodents in vivo, cynomolgus, i.v., p.o. Immunogenicity ADA studies in rodents surface plasmon resonance ADA studies in non-rodents surface plasmon resonance T cells in vitro Routine parameters rats Routine parameters cynomolgus Metabolization Free fraction blood, human cells Stability in plasma, SGF, SIF and microsomes in vitro Toxicology 10-day repeated-dose toxicity study in vivo, rat, p.o. Dose-range-finding study in vivo, cynomolgus, p.o. 4-week repeated dose toxicity in rodents, GLP in vivo, rat, p.o. 4-week repeated dose toxicity in non-rodents, GLP in vivo, cynomolgus, p.o. Genotoxicity AMES, GLP in vitro, salmonella typhimurium reverse mutation assay Micronucleus in vitro, CHO-K1

SLIDE 10

Development Plan

Phase II Clinical Trial of PRI-002

Step Activity 2015 2016 2017 2018 2019 2020 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 1 Bionalytical method development and validation (GLP) 2 API manufacture development (supply for tox/safety) 3 GLP tox studies in rat & cynomolgus (4 weeks) 4 PK in rat & cynomolgus 5 Safety pharmacology (GLP) 6 API manufacture phase I (GMP, kg-scale) 7 Clinical trial application phase I (SAD) 8 SAD clinical phase I trial 9 MAD clinical phase I trial 10 API manufacture for 6/9-months tox rat & cyno (GMP) 11 6/9-months tox in 2 species supporting phase II approval 12 Formulation development for phase II 13 API manufacture phase II 14 IMP manufacture for clinical supply phase II 15 Clinical phase II trial accomplished

ngoing

planned

SLIDE 11

Intellectual Property Rights

Ten patent families fjled in EU, US, JP, CN. The most important ones have been fjled in 2013. Most of them are either granted or about to be granted by the respective agencies.

Polymers containing multivalent amyloid-beta-binding D-peptides and their use

Publication number: WO 2013150127 A2

Filed: April 5, 2013

DE, EP, CN, JP, US Method for treating blood, blood products and organs

Publication number: WO 2013150126 A3

Filed: April 5, 2013

DE, EP, CN, JP, US Novel D-enantiomeric peptides derived from D3 and use thereof

Publication number: WO 2014041115 A2

Filed: September 13, 2013

DE, EP, CN, JP, US

SLIDE 12

Unique Selling Propositions

➔ New mechanism of action § Specifjc elimination of toxic Aβ oligomers ➔ New drug substance class § Synthetic all-D-peptide ➔ Oral drug administration § Protease-resistant

SLIDE 13

All-D-Peptides

Our platform for the generation of CNS drugs All-D- Pep(des

Mirror- Image Phage Display Microarray Chemical Modifica;on Ra;onal Design

Pre-clinical studies and Clinical Trials

➔ All-D-peptides combine the stability of small molecules with the selectivity of proteins and antibodies.

SLIDE 14

Indica(on Target Compound Screening/ Design POC Animal IND Package* Phase I Clinical Trial Phase II Clinical Trial

Alzheimer´s Aβ PRI-002 ALS Inflamma;on PRI-003 ALS SOD1 in progress Tauopathies Tau in progress Hun(ngton´s PolyQ in progress Parkinson´s α-Synuclein in progress

The Drug Pipeline

All-D-Peptide compounds and development status

*Toxicology | Safety | Pharmacokinetics

SLIDE 15

The Founders

Expertise in Life Science, Health Care, and Corporate Development

Knut Adermann

Director CMC

Dagmar Jürgens

Director Clinical Development

Dieter Willbold

Chairman of the Supervisory Board

Antje Willuweit

Director Preclinical Research

Ralph Zahn

Managing Director

Gunther Kauselmann

Director of Quality Management and Regulatory Compliance

SLIDE 16

Company Presentation, BIO, June, 2017

Priavoid

A life without dementia

(co-founder and future Chairman of the Supervisory Board)

The Company

At a glance

Our Vision

A life without dementia

➔ We want to stop Alzheimer’s disease using a new treatment strategy that employs a new class of orally available compounds. ➔ In parallel, this new strategy is also applied to

Alzheimer’s Disease

Registered drugs address only symptoms and have severe side effects

Intervention Strategies

Up to now, no disease modifying drug has been approved Monoclonal an(bodies binding to Aβ Aβ oligomer (toxic) Aβ fibril Aβ monomer APP beta and gamma secretase inhibitors

Intervention Strategies

Our strategy is to directly eliminate cytotoxic Aβ oligomers

PRI-002

(all-D-enan(omeric pep(de) Aβ oligomer (toxic) Aβ fibril Aβ monomer APP

Primary Pharmacodynamics - in vitro

QIAD: Quantitative determination of interference with Aβ aggregate size distribution PRI-002 eliminates toxic Aβ oligomers

Primary Pharmacodynamics

Most important results

Eliminates oligomers (QIAD)

Improves spatial learning and cognition after oral treatment (Morris water maze test, two mouse models)

Deceleration of neurodegenerative progression (SHIRPA test, third mouse model)

Pharmacokinetics and Toxicology

Overview of studies

Development Plan

Phase II Clinical Trial of PRI-002

Intellectual Property Rights

Ten patent families fjled in EU, US, JP, CN. The most important ones have been fjled in 2013. Most of them are either granted or about to be granted by the respective agencies.

Unique Selling Propositions

➔ New mechanism of action § Specifjc elimination of toxic Aβ oligomers ➔ New drug substance class § Synthetic all-D-peptide ➔ Oral drug administration § Protease-resistant

All-D-Peptides

Our platform for the generation of CNS drugs All-D- Pep(des

Mirror- Image Phage Display Microarray Chemical Modifica;on Ra;onal Design

Pre-clinical studies and Clinical Trials

➔ All-D-peptides combine the stability of small molecules with the selectivity of proteins and antibodies.

The Drug Pipeline

All-D-Peptide compounds and development status

The Founders

Expertise in Life Science, Health Care, and Corporate Development

A life without dementia

Thank you for your attention!

We are here to fjnd investors and/or partners to carry out a Clinical Phase II study