Less than two years after launching its new venture with $50 million in the bank, Reneo Pharmaceuticals follows up in a $95M Series B to further its mission to treat diseases of the mitochondria.
The company also tapped Gregory Flesher, as its new CEO. Flesher brings more than 25 years of biopharmaceutical industry experience, including senior leadership roles at Novus Therapeutics, Avanir Pharmaceuticals, Intermune, and Amgen, among others.
The funding will help support the company’s research into genetic mitochondrial diseases. It also provides the company a three-year runway, taking them through the completion of three early-to mid-stage trials for their lead program, REN001.
“The Series B includes well known investors in the industry that will fund the company for the next three years as well as help us through the completion of three clinical studies,” said Flesher. “One will be in primary mitochondrial myopathies (PMMs), which we hope will be a pivotal study for the company.”
The Series B financing was co-led by Novo Ventures and Abingworth, with participation from New Enterprise Associates, RiverVest Venture Partners, Pappas Capital and Lundbeckfonden Ventures. New investors included Rock Springs Capital, Aisling Capital, Amzak Health and others.
Reneo was founded by local biotech executives Niall O’Donnell and Mike Grey, who previously worked together at San Diego’s Lumena Pharmaceuticals.
That rare disease company was acquired in 2014 for $260 million up front by Shire, which is now part of Takeda Pharmaceutical. The duo would later join forces to launch Reneo in 2018.
Focused on Mitochondria
REN001 is a PPAR-delta agonist being studied in primary mitochondrial myopathies, fatty acid oxidation disorders and McArdle disease. All three conditions are related to different parts of mitochondrial function, as patients struggle with metabolizing different parts of food.
Given that mitochondria produce the energy needed for cells to thrive, the end result is fatigue and having trouble doing any sort of physical activity for longer than a few minutes.
REN001, a once-daily pill, has the ability to help cells express certain genes within the mitochondria that increase a patient’s metabolism.
The drug has potential to help both kinds of diseases, said Flesher.
The drug is not a gene therapy, and the ultimate goal is to both increase the amount of mitochondria that are replenished once the old ones die off, in addition to boosting enzyme production within the energy centers.
Clinical Trials in 2021
Despite the coronavirus stopping their Phase Ib trial early, the company still showed that their drug candidate REN001 was safe in PMM patients, paving the way to a large trial slated to begin in early 2021.
Reneo plans to start a double-blinded, placebo-controlled Phase II in PMM with the goal of enrolling about 200 patients.
The primary endpoint will involve some sort of walk test, measuring how far and how long patients can travel by foot, which has a direct correlation with daily quality of life.
The FDA also gave REN001 Orphan Drug Designation for PMM back in June 2020.
No FDA-approved therapies exist for PMM, as of now. Some patients take combinations of vitamins and supplements in an effort to ameliorate the symptoms. The reduced muscle function that characterizes the diseases can make it harder to go about daily functions and reduce life expectancy.
Reneo’s team of about 26 people is split between the UK and San Diego. The group in the UK, handles its clinical operations. Reneo plans to add to its headcount to handle the responsibilities of a large global trial, adding up to 10 additional staffers. O’Donnell, will remain as a member of the board of directors.
“Our goal is to commercialize the product ourselves. To do that, we’ll have to access more capital. We will explore the public markets in 2021,” said Flesher. “We’re one of many companies attempting to improve the lives of patients. We have a lot of milestones over the next two years. And we believe we’re doing work that’s a little different than the standard in our industry.”