NextUp: The Radnor-Based Biopharma Company Developing a Hormone-Targeting Treatment for Hypertension

Mineralys Therapeutics just completed a $40 million Series A funding round, which will allow them to take their lead drug candidate MLS-101 into a Phase II proof-of-concept study.

Mineralys Therapeutics

BT Slingsby (left) and Jon Congleton. Photographs courtesy Mineralys Therapeutics

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Who: In early 2019, U.S.-born, Japan-based doctor and life sciences maven BT Slingsby founded Catalys Pacific, an independent venture capital firm that creates and invests in global bioventure companies seeking novel biotechnology and healthcare solutions. The following year, Catalys Pacific launched Mineralys Therapeutics, which is focused on hypertension and comorbidity disorders. Due to the pandemic, Slingsby put together a virtual team for Mineralys, naming Jon Congleton — a 30-year biopharmaceutical veteran — as CEO.

What: Based in Radnor, Mineralys Therapeutics is a private, clinical-stage biopharmaceutical company working to treat hypertension by targeting aldosterone, a hormone that, when the body produces too much of it, has been linked to increased blood pressure. Raised aldosterone levels can drive up blood volume and blood pressure and cause heart and kidney problems. Mineralys’s lead drug candidate, MLS-101, is a highly selective aldosterone synthase inhibitor designed to reduce elevated aldosterone levels.

When: Japan’s Mitsubishi Tanabe Pharma Corporation conducted a Phase I study on MLS-101 in healthy volunteers in 2017. The study validated that MLS-101 not only reduced aldosterone in participants, but demonstrated a safe, tolerable profile and did not impact other hormones like cortisol. After Mineralys obtained licensing of MLS-101 from Mitsubishi Tanabe last summer, the Philly-area company focused its attention on regulatory interaction and financing. Last month, Mineralys completed a $40 million Series A funding and had their Investigational New Drug (IND) application accepted by the FDA. Both achievements enable Mineralys to proceed with its Phase II proof-of-concept study of MLS-101.

Congleton says the goal of this study, which will be conducted over eight weeks, is to show the selectivity of MLS-101 in reducing aldosterone and having a robust effect on blood pressure. “This will be the first time MLS-101 is tested on hypertensive patients,” he says. “The patients we’re recruiting are those who are already taking background medications, but not achieving their goals. That means MLS-101 will be added to their pre-existing medication regimens, and studied for the minimally-effective and maximally-tolerated doses.”

Looking ahead, Congleton says Mineralys plans to read out data in 2022, anticipating a pivotal study launch beginning in 2023. The latter, he adds, would help progress getting MLS-101 to the market and available to patients.

What it means: Congleton says that while targeting aldosterone is not a new solution to treating hypertension, there has been a lack of selectivity in inhibiting only CYP11B2, an enzyme responsible for aldosterone synthesis. In the past, he mentions, other attempts have inhibited the cortisol pathway, which is problematic because a cortisol reduction often counters the blood pressure lowering effect of aldosterone reduction. Congleton believes MLS-101 has the potential to address the unmet need of hypertension in a way that is more selective and does not affect off-target hormones and enzymes.

Why it matters now: According to the World Health Organization, 1.13 billion people worldwide live with hypertension. The condition, they note, still remains a major, global cause of premature death. And yet, the CDC says that only about a quarter of hypertension patients achieve blood pressure control. Congleton says that well-controlled blood pressure is essential to mitigating the chances of life-threatening medical conditions, including stroke, atrial fibrillation, cardiac failure, and chronic kidney disease. Additionally, a recent study found that aldosteronism-driven hypertension is more common than previously thought. “Overall, unmanaged hypertension is really the tip of the iceberg of poor health outcomes,” Congleton says. “Treating the underlying cause of hypertension, especially in those with elevated aldosterone production, can help increase patients’ long-term health outcomes and overall quality of life.”