Mineralys hauls in $118M series B to advance hypertension med through phase 2 trial

Mineralys Therapeutics has raked in $118 million in series B funds to continue advancing its hypertension med through the clinic, first and foremost by sprinting through the finish line of an ongoing phase 2 trial. 

The haul, announced Wednesday, is nearly triple the $40 million series A round closed in April 2021, indicative of the budding investor interest as the company’s sole asset, MLS-101, continues clinical development. While the therapy is currently progressing through a phase 2 proof-of-concept study, subsequent trials have yet to be determined, CEO Jon Congleton said in an interview. The ambiguity is due to the company waiting on looming trial results to determine whether there are future biomarkers that are worth further interrogating and testing for. 

“That’ll be a part of what the future development will be around, continuing to validate the efficacy and the safety of MLS-101 but concurrently try and develop tools that really help identify those patients that would do best with this treatment,” he said. The company expects to have top-line results of the phase 2 trial later this year. 

The asset at play was initially licensed by Mineralys from Mitsubishi Tanabe in July 2020 before launching into phase 1 early last year. By targeting the CYP11B2 pathway, the drug seeks to inhibit aldosterone, a steroid hormone that when elevated, can cause hypertension or high blood pressure. The condition is often a trigger for more severe kidney or heart diseases. 

As the company furthers its development program, adequately recruiting a diverse patient population will be paramount. Hypertension impacts Black people more than any other racial demographic, with one analysis from the American Heart Association finding that the age-adjusted prevalence of hypertension was 16 percentage points higher among Black women than their white counterparts. Congleton said an interim analysis of the phase 2 trial demographic showed that there was a 60-40 split of white patients to Black. The company was “mindful” of having adequate representation so that the trial could effectively inform future development, he added.

As for Mineralys' future development plans, Congleton says the company will likely look at first expanding the indications of MLS-101, given that aldosterone plays a role in a number of cardio-metabolic disorders. “Aldosterone, unfortunately, has kind of a fingerprint on a lot of different pathologies,” the CEO said. “The good news is, if in fact our drug yields the kind of profile that we think it does, it could have utility in more than just hypertension.”