The IPO window is looking wide open these days, with yet another biotech planning its Nasdaq debut. This time, it’s Applied Therapeutics, which is aiming to raise $86 million to bankroll a trio of assets through the clinic.
The New York-based biotech will advance three drugs that target aldose reductase, an enzyme that converts glucose into sorbitol, a sugar alcohol involved in multiple diseases including complications of diabetes. Previous efforts to block aldose reductase have had limited success as they have not been selective or specific enough, Applied Therapeutics said in an SEC filing on Friday. The company has designed its drugs to overcome these challenges.
Specifically, Applied Therapeutics will fund a pivotal phase 2/3 study for its lead program, AT-001, in diabetic cardiomyopathy, as well as a phase 1 study of a second drug, AT-007, in galactosemia, a rare genetic disorder that affects how the body processes galactose, a simple sugar. Galactose is produced in the body at low levels and, along with glucose, makes up lactose, found in milk and dairy products. There are a few types of galactosemia, which differ in severity and symptoms. But Type 1, the most severe kind, can be fatal if not caught early in life. Both trials are slated to start this year.
The company will also use the funds to start a phase 1 study testing AT-003 in patients with diabetic retinopathy in 2020. Caused by damage to nerves in the retina, diabetic retinopathy is the leading cause of vision loss in people with diabetes. Early-stage disease may not need treatment; a doctor may instead monitor changes in the eye or work with the patient on controlling their blood sugar to ward off any worsening of the disease. Advanced patients can be treated with surgery and/or injecting anti-VEGF drugs into the eye.
In addition to its aldose reductase programs, Applied Therapeutics is also working on a PI3K (phosphatidylinositol 3-kinase) inhibitor for blood cancers. It is developing the drug, AT-104, for peripheral T-cell lymphoma, cutaneous T-cell lymphoma and T-cell acute lymphoblastic leukemia and aims to bring it into the clinic in 2020.
Applied Therapeutics recently snagged itself a new chief medical officer. Last September, Dr. Riccardo Perfetti joined the company from Sanofi, where he had served as vice president and senior medical officer.