Anthem Conference: AN2 Therapeutics Teases Phase II Data Across 3 Programs

AN2 Therapeutics outlined plans for multiple Phase II programs during a presentation at the Jefferies Global Healthcare Conference, with Chief Executive Eric Easom emphasizing the company’s boron chemistry platform and a pipeline focused on infectious disease, hematology and oncology.

Easom said AN2 has three clinical-stage assets now in Phase II proof-of-concept studies or moving into them, including programs in polycythemia vera, Mycobacterium abscessus lung disease and Chagas disease. He said two of the targeted indications have no FDA-approved therapies.

“Near term, we’re going to have data on all three of these programs,” Easom said, adding that updates are expected beginning in the fourth quarter and continuing through next year.

Polycythemia Vera Program to Start Phase II in Third Quarter

Easom described polycythemia vera, or PV, as the company’s latest pipeline addition and said AN2 plans to begin a Phase II study of oral epetraborole in the third quarter. PV is a blood disorder characterized by excess red blood cells, which can increase the risk of thrombotic events such as stroke.

According to Easom, epetraborole is designed to target red blood cells specifically, potentially avoiding broader effects on other blood cell lines that can occur with cytoreductive therapies. Current approaches include phlebotomy, low-dose aspirin and drugs such as hydroxyurea.

The planned Phase II study will begin with a 10-patient sentinel group receiving a low dose of 250 mg every other day to evaluate safety and pharmacokinetics in PV patients. A subsequent dose-titration portion will begin at 250 mg once daily, with the potential to increase to 500 mg or 750 mg once daily based on patient needs.

Easom said the trial will enroll phlebotomy-dependent patients who have required at least three phlebotomies over the prior 24 weeks. Patients may also be receiving cytoreductive therapy, with epetraborole added on top.

AN2 expects data from the initial sentinel group later this year, though Easom cautioned that efficacy may be limited at the low starting dose. He said more meaningful open-label dose-titration data are expected from early 2027 into midyear.

Mycobacterium Abscessus Study Underway

AN2 is also studying epetraborole in Mycobacterium abscessus, a nontuberculous mycobacterial lung infection. Easom said the disease is chronic, can significantly impair lung function and has no FDA-approved therapy.

He said the condition affects about 15,000 patients in the United States and roughly 50,000 in major markets. Existing treatment often relies on older antibiotics, including daily IV infusions in multidrug regimens.

“The idea of having an oral therapy as kind of backbone to this regimen, and ultimately an all-oral regimen, would be a huge advancement to patients and their quality of life,” Easom said.

The company has initiated an 84-patient Phase II investigator-initiated trial led by Kevin Winthrop of Oregon Health & Science University, whom Easom described as a world expert in the field. The study includes microbiological and patient-reported outcome endpoints, with data expected late next year.

Easom said preclinical testing showed epetraborole was potent against more than 100 clinical isolates from patient lungs. He also cited animal data comparing the oral drug with imipenem, an IV antibiotic he called a gold-standard therapy, and omadacycline, another oral drug in development.

Chagas Disease Data Support Phase II Plans

AN2 also highlighted its Chagas disease program, which targets a parasitic infection that can affect heart muscle and lead to heart failure or other serious outcomes in about 30% of patients, according to Easom.

The company said in a press release earlier in the day that Phase I data for its oral candidate AN2-502998 showed a pharmacokinetic and safety profile supporting Phase II studies. Easom also pointed to non-human primate data, which he said demonstrated parasite cure in naturally infected monkeys.

“This is about as close to proof of concept as you could get,” Easom said.

He said there are about 10 million Chagas patients globally and an estimated 300,000 or more in the United States, though he noted the disease is not well measured domestically. He also said there is no FDA-approved treatment for chronic Chagas disease.

AN2 plans to initiate a Phase II study later this year and expects top-line data around the third quarter of next year.

Oncology Programs Remain Earlier Stage

Beyond its three clinical programs, Easom briefly discussed research-stage oncology efforts enabled by the company’s boron chemistry platform. He said AN2 is working on a PI3 kinase program and an ENPP1 program, though he spent less time on those assets during the presentation.

Easom concluded by emphasizing that AN2 expects several clinical readouts across its lead programs, which he said could create value while addressing serious diseases with limited treatment options.

About Anthem (NASDAQ:ANTX)

Anthem, Inc, through its subsidiaries, operates as a health benefits company in the United States. It operates through three segments: Commercial & Specialty Business, Government Business, and Other. The company offers a spectrum of network-based managed care health benefit plans to large and small group, individual, Medicaid, and Medicare markets. Its managed care plans include preferred provider organizations; health maintenance organizations; point-of-service plans; traditional indemnity plans and other hybrid plans, such as consumer-driven health plans; and hospital only and limited benefit products.