Contribution: Industrial Research Assistance Program – Contributions to Firms
PEARKO Therapeutics Inc.
$140,000.00
Preclinical Development of Apelin Analog and Completion of Regulatory Procedures
FY 2019-20 · 2020-01-01
Summary
PEARKO Therapeutics’s apelin analog will be synthesized by Bachem, a Good Manufacturing Practices (GMP)-certified producer of peptides for clinical use. We will use study findings to optimize intravenous and subcutaneous formulations of our biologic, and scale-up production. Over the same period, regulatory filings will be completed for Health Canada, the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to augment the clinical trial process and international market entry. Completion of these steps will allow PEARKO Therapeutics to proceed through the final stages of preclinical development and complete the Investigational New Drug application, mandated by the FDA, in anticipation of Phase I clinical trials in 2022.
Department
Program
Industrial Research Assistance Program – Contributions to FirmsIndustrial Research Assistance Program-Contributions to Firms (linked with high confidence)
Recipient
Location
Edmonton|Edmonton, Alberta, Canada
Recipient Type
For-profit organization
Business Number
824764641
Type
Contribution
Source
Proactive Disclosure - Grants and Contributions
As published
Additional Information
This agreement has been amended 1 time(s). The total amended value is 140,000 dollars.
Additional Information (French)
Cet accord a été modifié 1 fois La valeur totale des modifications est de 140 000 dollars.
Agreement End Date
2021-03-31
Agreement Number
939480
Agreement Start Date
2020-01-01
Agreement Title
Preclinical Development of Apelin Analog and Completion of Regulatory Procedures
Agreement Title (French)
Développement préclinique d'un analogue de l'apeline et achèvement des procédures réglementaires
Agreement Type
Contribution
Agreement Value
$140,000.00
Amendment Date
2020-02-28
Amendment Number
1
Coverage
IRAP Contributions to Firms projects stimulate wealth creation for Canada through technological innovation. | Les projets des Contributions aux entreprises stimulent la création de richesse au Canada grâce à l’innovation technologique.
Description
PEARKO Therapeutics’s apelin analog will be synthesized by Bachem, a Good Manufacturing Practices (GMP)-certified producer of peptides for clinical use. We will use study findings to optimize intravenous and subcutaneous formulations of our biologic, and scale-up production. Over the same period, regulatory filings will be completed for Health Canada, the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to augment the clinical trial process and international market entry. Completion of these steps will allow PEARKO Therapeutics to proceed through the final stages of preclinical development and complete the Investigational New Drug application, mandated by the FDA, in anticipation of Phase I clinical trials in 2022.
Description (French)
L'analogue de l'apeline de PEARKO Therapeutics sera synthétisé par Bachem, un producteur de peptides à usage clinique certifié BPF (Bonne pratiques de fabrication). Nous utiliserons les résultats de l'étude pour optimiser les formules intraveineuses et sous-cutanées de notre production biologique et à grande échelle. Au cours de la même période, Santé Canada, la Food and Drug Administration (FDA) et l'Agence européenne des médicaments (AEM) effectueront des dépôts réglementaires afin d'accroître le processus d'essais cliniques et la mise en marché internationale. L'achèvement de ces étapes permettra à PEARKO Therapeutics de franchir les dernières étapes du développement préclinique et de finaliser la demande de drogue nouvelle de recherche, mandatée par la FDA, en prévision des essais cliniques de phase I en 2022.
Expected Results
The purpose of IRAP Contributions to Firms is to support research, development, adoption and/or adaptation of innovative or technology-driven new or improved products, services or processes in Canada up to their commercialization
Expected Results (French)
Le PARI, par le biais des Contributions aux entreprises, vise à appuyer la recherche, le développement, l’adaptation et/ou l’adoption au Canada de produits, de services ou de processus novateurs ou axés sur des technologies nouvelles ou améliorées, et ce jusqu’à leur commercialisation
Federal Riding
Edmonton Riverbend
Federal Riding (French)
Edmonton Riverbend
Federal Riding Number
48018
NAICS Code
541710
Organization Code
nrc-cnrc
Organization
National Research Council Canada | Conseil national de recherches Canada
Program Name
Industrial Research Assistance Program – Contributions to Firms
Program Name (French)
Programme d’aide à la recherche industrielle – Contributions aux entreprises
Program Purpose
The purpose of IRAP Contributions to Firms is to support research, development, adoption and/or adaptation of innovative or technology-driven new or improved products, services or processes in Canada up to their commercialization
Program Purpose (French)
Le PARI, par le biais des Contributions aux entreprises, vise à appuyer la recherche, le développement, l’adaptation et/ou l’adoption au Canada de produits, de services ou de processus novateurs ou axés sur des technologies nouvelles ou améliorées, et ce jusqu’à leur commercialisation
Recipient Business Number
824764641
Recipient City
Edmonton|Edmonton
Recipient Country
CA
Recipient Legal Name
PEARKO Therapeutics Inc.
Recipient Postal Code
T6R 3A5
Recipient Province or Territory
AB
Recipient Type
F
Reference Number
172-2019-2020-Q4-939480
