Novo and Abingworth back a $95M Series B for Reneo Pharmaceuticals, which aims to treat diseases of the mitochondria
Less than two years after its coming-out party with a $50 million launch round, Reneo Pharmaceuticals returned to the venture well and reeled in some high-profile backers.
The San Diego-based biotech announced the closing of its $95 million Series B on Wednesday morning, co-led by Novo Ventures and Abingworth, to support its research into genetic mitochondrial diseases. Wednesday’s cash will give the company a three-year runway, taking them through the completion of three early- to mid-stage trials for their lead program, REN001.
Gregory Flesher, the former CEO of Novus Therapeutics, is also joining Reneo to steer the ship.
Returning investors included New Enterprise Associates, RiverVest Venture Partners, Pappas Capital and Lundbeckfonden Ventures. Investing for the first time are Rock Springs Capital, Aisling Capital, Amzak Health and others.
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.
Sometimes, the energy levels are so low that the stress placed on the musculoskeletal system and vital organs can lead to other diseases.
Flesher tells Endpoints News that REN001, a once-daily pill, has the ability to help cells express certain genes within the mitochondria that increase a patient’s metabolism. He emphasized that 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.
Though the mitochondria are smart and can adapt to some shortcomings initially, like using different starting points if a certain area is deficient, ATP production ends up tapering off after those first few minutes because there’s not enough building blocks. In FAOD, the patients can’t process fat into fatty acids and then ATP, for example, and in McArdle disease, they can’t process glycogen into glucose, Flesher said.
“Any drug product or therapeutic approach that can ramp up one or more of the inbound paths to creating ATP can be really helpful for these patients, and that’s why we’re exploring multiple subgroups of patients that cannot produce ATP,” Flesher said.
Reneo is planning on starting a double-blinded, placebo-controlled Phase II in PMM early next year 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. Data will likely read out toward the end of the Series B runway, Flesher said.
The company is also running two Phase Ib trials in FAOD and McArdle disease, which will come out with data sometime in late 2021 or early 2022.
“To have a strong investor syndicate … it really is, I’d probably not say stamp of approval, but more a recognition that the therapeutic approach, the modality and the patient population is important, and people would like to see a product approved,” Flesher said.