MBX Biosciences gets green light from FDA
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MBX Biosciences, a Carmel startup that has raised an eye-popping $150 million in venture funding, has received clearance from federal regulators to move its second experimental drug into human testing.
The U.S. Food and Drug Administration gave the green light to MBX to test a drug for post-bariatric hypoglycemia, a rare disease and a serious complication of bariatric surgery, the company said Monday.
The disease is marked by repeated episodes of extremely low blood sugar, triggered by excessive insulin levels following a meal. Episodes can occur multiple times per day, with severe symptoms such as dizziness, confusion, loss of consciousness or seizures. As a result, many patients cannot live, work or drive alone.
The company said it plans to enroll patients in early-stage clinical trials in the third quarter of this year and report summary results in the second half of 2024.
CEO Kent Hawryluk called the FDA action a “significant milestone” for the four-year-old company. He said the experimental drug, called MBX 1416, could become a potential first-in-class treatment for the disease, which has no approved medical treatment by means of drugs.
MBX was founded in 2019 by Hawryluk and his longtime partner, Indiana University chemistry researcher and serial entrepreneur Richard DiMarchi.
DiMarchi and Hawryluk worked together on two previous Indiana startups, Marcadia Biotech and MB2, which developed technology for metabolic diseases such as diabetes and obesity.
Marcardia was later bought by Swiss pharmaceutical giant Roche. Denmark-based Novo Nordisk later bought MB2.
In scientific terms, MBX 1416 is an investigational, long-acting GLP-1 receptor antagonist, which means it is designed to block the action of a hormone that stimulates insulin secretion. MBX said the drug was designed using the company’s proprietary Precision Endocrine Peptide platform.
The company’s pipeline includes its lead product candidate, MBX 2109, currently in early-phase clinical trials for the treatment of hypoparathyroidism, a rare condition marked by a variety of symptoms, including muscle cramps and spasms in the hands and feet and numbness or tingling around the mouth and fingers and toes, as well as depression, confusion and loss of memory.
DiMarchi has set up at least five companies since retiring from Indianapolis-based Eli Lilly and Co. in 2003 as group vice president for biotechnology research and product development. He has more than 100 patents and has published more than 150 scientific papers.
His other startups include Ambryx, Assembly Biosciences and Calibrium. All of the startups were sold, reaping more than $500 million for founders and investors.
Major backers of MBX include Frazier Life Sciences, New England Associates, Norwest Venture Partners, OrbiMed, RA Capital Management and Wellington Management.