Draft:Cardior Pharmaceuticals

Cardior Pharmaceuticals GmbH is a clinical-stage biopharmaceutical company based in Hanover Germany founded in 2016. The company is developing curative and preventive heart failure therapeutics based on non-coding RNAs (ncRNAs).

Scientific approach
Cardior’s approach is based on the latest research in non-coding RNAs biology and addresses the root causes of heart failure (HF) development. Non-coding RNAs (ncRNAs) are important regulators for many cellular processes, particularly in pathological condition or during disease. In heart disease or following cardiac stress such as myocardial infarction (MI), the human heart undergoes a process termed cardiac remodeling. This is initially an adaptive response, but it soon leads to pathological cardiac hypertrophy, fibrosis altering the biomechanical properties of the heart, and finally to impairment of contractility function so the heart is unable to effectively pump blood through the body and deliver enough oxygen and nutrients to the organs. Currently available therapeutic solutions deal with the consequences of heart failure, alleviate the symptoms but do not halt its development.

A certain non-coding RNA, MicroRNA-132 (miR-132), present in cytoplasm of cardiac muscle cells, was identified by Hannover Medical School (MHH) as an important indicator of cardiac stress and the main trigger of cardiac remodeling. An increase of miR-132 in cardiac tissue drives abnormal expression of genes that are crucially involved in cardiac function and derail cellular signaling leading to cardiac remodeling and heart failure.

CDR132L - Cardior’s lead candidate - is designed to address the root cause of pathological remodeling of the heart following MI and thereby halt and reverse the detrimental signaling cascade and restore normal function of the heart. CDR132L blocks abnormal levels of miR-132 thus triggering a concerted therapeutic effect against key hallmarks of heart disease by normalization of derailed gene expression signatures. These include expression of genes regulating cardiac hypertrophy, fibrosis, impaired contractility, and reduced vascularization.

Initially evaluated in mice with pressure-overload induced heart failure and in miR-132 transgenic HF mouse models, CDR132L treatment reduced functional miR-132 level and reversed cardiac dilatation along with an improvement of cardiac function. The safety and therapeutic efficacy of CDR132L was further assessed in numerous large animal models.

Clinical study
The first-in-human Phase 1b clinical study confirmed CDR132L to be safe and well-tolerated having demonstrated first beneficial cardiac signs in heart failure patients (NCT04045405) CDR132L is currently being investigated in the company’s Phase 2 HF-REVERT trial. HF-REVERT is a multicenter, randomized, parallel 3-arm, placebo-controlled study to assess the efficacy and safety of CDR132L in 280 patients with reduced LVEF after myocardial infarction. The study is being conducted at over 70 clinical study centers across Europe.

CardiorHealth miR-132 PCR kit
Cardior has developed a PCR kit to measure the levels of microRNA-132 (miR-132) circulating in the blood of the patients receiving the company’s lead candidate CDR132L, an oligonucleotide-based miR-132 inhibitor. The marking for CardiorHealth miR-132 PCR kit was received in September 2022. CE Marking is an acronym for the French “Conformité Européenne” certifying that a product has met EU health, safety, and environmental requirements, which ensure consumer safety.

Financing
BioMedPartners, Bristol Myers Squibb, Coparion, EQT, Fund+, Hadean Ventures, INKEF Capital, High-Tech Gründefunds, Sunstone.

Patents
Cardior holds an IP portfolio of over 150 patents and applications in 35 countries exclusively licensed to or owned by the Company.

Timeline

 * 2016 - Cardior Pharmaceuticals GmbH founded in Hanover, Germany
 * 2017 - Lead compound selection
 * 2020 - Phase 1b Clinical Study completed
 * 2022 - Start of HF-REVERT Phase 2 Study in heart failure patients