Corteria: a new strategy and approach to treating heart failure

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Corteria Pharmaceuticals is developing transformative therapies for heart failure subpopulations most likely to benefit from the company’s novel cardiorenal treatments. The company was founded in 2021 by Sanofi’s former head of cardiovascular research, Philip Janiak, and Marie-Laure Ozoux, former cardiovascular project leader at Sanofi.

Our heart is one of the most resilient organs in our body. But despite this extraordinary fortitude, heart failure is on the rise, currently affecting more than 60 million patients worldwide. It is in fact the only category of cardiovascular disease which continues to grow, in spite of the best efforts to address the problem.

Corteria Pharmaceuticals is tackling specific forms of heart failure using a unique strategy and approach. The French company in-licensed from two Sanofi cardiovascular programs.

“At Corteria, we are developing drugs to address heart failure subpopulations,” Janiak explains. “We have three programs in development: the first is focusing on worsening heart failure; the second on acute heart failure with hyponatremia; and the third on right heart failure. For each of these indications, there are no treatments currently approved, despite the high unmet medical need and growing number of patients.”

A strategy of stratification

The cardiovascular field – and particularly heart failure – has developed a poor reputation in the pharmaceutical industry, with the failure of many complex and large Phase III clinical trials. Corteria is however using a novel strategy to improve its chances of success.

“We know that heterogeneity in heart failure populations and lack of understanding of human disease biology have been contributing factors to failures in past trials,” says Janiak. “Instead of targeting broad chronic heart failure populations, we are attempting to stratify the patient population – identifying and defining the specific subgroups that are most likely to benefit from our treatments. This is possible thanks in part to our Phase 0 observational study that was just completed in worsening heart failure.”

“Instead of targeting broad chronic heart failure populations, we are attempting to stratify the patient population – identifying and defining the specific subgroups that are most likely to benefit from our treatments.” – Philip Janiak

The company’s lead program is a long-acting peptide drug for worsening heart failure, a condition characterized by shortness of breath, fatigue, swelling, and rapid heartbeat. As the heart becomes too weak to pump blood properly, together with kidney dysfunction, fluid builds up in the patient’s organs including lungs and legs. The condition is currently managed by administering a loop diuretic via IV to reduce this congestive build-up of fluid.

“Worsening heart failure is a life-threatening condition, and the current standard of care doesn’t address the root cause of the problem. One third of patients treated with diuretics will be readmitted to hospital with recurrent congestion within six months. This patient group is the subpopulation we are hoping to serve.”

The company is conducting a Phase 0 observational study to improve the probability of success of its Phase II study, which is aimed to initiate in 2025. “We are performing a deep phenotyping of this patient population to identify the residual congestion signatures that will be used to select the trial participants, including a range of parameters such as biomarkers, echocardiography data, and quality of the life evaluations,” Janiak explains. “It’s quite a new approach in the field, and it would provide effective treatments to the patients.”

A whole-body approach

Corteria’s second drug candidate is another long-acting peptide, under preclinical investigation for the treatment of right heart failure, as well as chronic diseases such as obesity and sarcopenia. Unlike these first two candidates, the company’s third program is a monoclonal antibody, used to treat acute heart failure with hyponatremia. Hyponatremia is a condition where the sodium level in the blood is too low, caused by elevation of the hormone vasopressin.

Patients with hyponatremia have a very poor prognosis, but they are extremely difficult to treat because the standard heart failure drugs – diuretics – may aggravate the hyponatremia. Doctors are forced to limit the patient’s water intake to deal with the issue. By neutralizing vasopressin, Corteria’s drug will normalize sodium levels while also reducing congestion. It is a unique approach: a first-in-class disease modifier.”

“The beauty of our products, and what sets them apart, is that they induce multi-organ benefits, acting on the kidneys, the vessels, and the heart.” – Philip Janiak

What unites these three different programs is that they are all employing multi-organ, broad approaches to tackling heart failure. The issue with many current heart failure drugs is that they are often quite organ selective. They are either cardiac-, renal-, or vascular-centric, and therefore fail to address complex conditions like worsening heart failure, which is a multiorgan failure syndrome. The probability of successfully treating such a cardiovascular situation will be low if you don’t target all of the organs affected by the disease. “The beauty of our products, and what sets them apart,” Janiak states, “is that they induce multi-organ benefits, acting on the kidneys, the vessels, and the heart.”

Funding for the future

When Corteria was founded in 2021, it raised a seed round of €15 million, complemented by a further €2 million in non-dilutive funding. The company is now in the process of raising a Series A, explains CFO Stéphane Durant des Aulnois:

“Our aim is to continue developing our three main programs, to bring our lead asset to the completion of Phase II, and our other two assets to the completion of Phase I, all by the end of 2025. Investor interest has been high, and we’ve also been receiving very positive feedback from both KOLs and regulators, who recognize the need for novel drugs in these specific indications.”

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“It’s good to have this external validation from both the clinical and regulatory standpoint,” Janiak confirms. “It reinforces our confidence that our strategy and approach will make a life-changing difference to the many heart failure patients whose needs are currently unmet by standard treatments.”