Reneo Raises $95 Million to Advance Rare Mitochondrial Disease Pipeline

Rare Daily Staff

Reneo Pharmaceuticals said it raised $95 million in a series B financing to advance its clinical stage pipeline focused on therapies for genetic mitochondrial diseases.

Novo Ventures and Abingworth co-led the financing with support from existing investors New Enterprise Associates, RiverVest Venture Partners, Pappas Capital, and Lundbeckfonden Ventures, as well as new investors Rock Springs Capital, Aisling Capital, Amzak Health, and other investors.

Reneo’s lead product candidate REN001 is an oral, once-daily experimental drug known to control several genes involved in mitochondrial activity. Mitochondria are the powerhouses of the cell, where carbohydrates, fats, and proteins are used to generate the energy the body needs. Reneo is developing REN001 as a first-in-class treatment option to improve cellular energy metabolism by enhancing mitochondrial function and potentially increasing the number of mitochondria.

The new funding will be used to achieve several key clinical milestones, including completion of a global phase 2 study in primary mitochondrial myopathies (PMM), a group of rare, often life-threatening diseases, caused by mutations in mitochondrial or nuclear DNA. These mutations hamper the ability of affected cells to break down food and oxygen and produce energy. There are no approved drugs for the treatment of PMM. Reneo is planning to initiate a global phase 2 clinical trial in PMM in early 2021, with trial sites located in the U.S., Australia, and Europe.

Reneo is also testing REN001 as a treatment for fatty acid oxidation disorders (FAOD), a group of rare, potentially life-threatening genetic metabolic disorders that affect the body’s ability to use fats from food as a source for energy, and McArdle disease (also known as glycogen storage disease type 5), a rare genetic metabolic disorder that affects the body’s ability to use muscle glycogen (stored glucose) as a source of energy for skeletal muscles. Reneo is currently enrolling phase 1b clinical trials of REN001 in both indications, with trial sites located in the United States and Europe.

Reneo also announced the appointment of Gregory Flesher as president, CEO, and a member of the board of directors. Flesher has more than 25 years of biopharmaceutical industry experience, including senior leadership roles at Novus Therapeutics, Avanir Pharmaceuticals, Intermune, Amgen, and Eli Lilly and Company. Niall O’Donnell, the founding CEO of Reneo and a managing director at RiverVest Venture Partners, will remain as a member of the board of directors.

Photo: Gregory Flesher, Reneo Pharmaceuticals president, CEO, and member of the board