32 Biosciences — pronounced “three-squared biosciences” — is a biotech company led by former executives at Johnson & Johnson and Abbott.
Its focus is on diagnosing and correcting Dysbiosis, a term for when the body’s microbiomes are imbalanced. Perhaps surprisingly, this imbalance is a central, but under-appreciated, driver of disease.
Dysbiosis contributes to diseases that carry more than one-and-a-half trillion dollars in U.S. economic burden. Yet there are no FDA-approved diagnostic tools that can accurately diagnose this condition. There are also no FDA-approved drugs that modulate microbiomes in the gut to prevent disease.
32 Biosciences is paving the way for these types of tools, starting with a mass spectroscopy panel it refers to as GB-0001.
Essentially, GB-0001 is a test that can quantitatively and precisely assess the functional health of the interaction between the human body and its gut microbiomes. This is the key to assessing and hopefully treating multiple under-recognized diseases.
The lead indication for GB-0001 will be Irritable Bowel Syndrome (IBS, for short). IBS is a diagnosis of exclusion and there are no FDA-approved tests for the diagnosis or management of this condition — one that impacts ten percent of Americans.
This condition alone represents a ten-billion-dollar total-available market (TAM) in the U.S., where roughly half of IBS patients seek medical care for their symptoms.
To complete the treatment process, 32 Biosciences is creating CS-0003, a non-antibiotic anti-infective drug that prevents bacterial infection by inhibiting the expression of potentially harmful genes.
This drug was invented after Dr. John Alverdy, 32 Biosciences’ Scientific Founder, discovered that many surgical site infections (SSIs) that occur today originate from within a patient’s own gut microbiome, rather than from external contamination.
CS-0003 has been shown to be effective against a variety of different strains of antibiotic-resistant bacteria in highly-clinically-relevant animal models.
32 Biosciences plans for the lead indication of CS-0003 to be SSI prophylaxis. SSIs represent an economic burden of billions of dollars in the U.S. And together, 32 Biosciences’ creations have the potential to transform medicine.
32 Biosciences is collaborating with leading academic institutions and business partners, including Johns Hopkins Medicine, the Cleveland Clinic, and the University of Chicago.
Its GB-0001 diagnostic tool is set to undergo clinical trials in 2025 with an expected launch date for 2026. Its CS-0003 therapeutic will begin Phase 1 clinical trials in 2025 and Phase 2 trials in 2026. A Commercial launch is slated for 2028.
To-date, 32 Biosciences’ scientific founders have received more than ninety million dollars in funding from the National Institutes of Health (NIH). And GB-0001 is projected to reach peak annual sales in the U.S. of more than two billion dollars by 2040. CS-0003 is expected to reach peak sales of $4.6 billion by 2037.