BiomX, APT merger to advance CF treatment BX004 into Phase 2 trial

Therapy aims to clear lung infections caused by P. aeruginosa bacteria

Margarida Maia, PhD avatar

by Margarida Maia, PhD |

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BiomX and Adaptive Phage Therapeutics (APT) are entering into a merger agreement with a goal of pooling resources to advance phage therapies such as BX004 — an experimental cystic fibrosis (CF) treatment that aims to clear up lung infections caused by Pseudomonas aeruginosa bacteria.

At the same time as the merger, BiomX is selling shares of a new type of stock called Series X Preferred Stock in a private placement to accredited investors. The private placement is expected to bring in gross revenue of $50 million for BiomX, according to a company press release.

The monies are expected to fund Phase 2b clinical testing of BX004, focused on how safe the potential CF treatment is and how well it works versus a placebo. A clinical trial involving as many as 60 people with CF is planned to start in the last three months of this year, with data readouts anticipated in the third quarter of 2025, the release stated.

“BX004 has the potential to improve lung function in patients with chronic and potentially deadly pulmonary [lung] infections,” said Jonathan Solomon, CEO and board member of BiomX.

“Investors who led this transaction” are confident “that phage technology holds significant potential to treat serious infections with significant unmet need and limited treatment options,” Solomon said.

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Jonathan Leff, partner and chairman of the Deerfield Institute at Deerfield Management, a leading investor in the transaction, called the expected data readout on the bacteria-targeting therapy “important” in BX004’s development program.

Overall, Leff said, “BiomX’s acquisition of APT will create a leading phage company with diverse technologies and an advanced clinical pipeline.”

In CF, thick mucus can trap harmful bacteria such as Pseudomonas aeruginosa, referred to as P. aeruginosa for short, in the airways and lead to serious infections that are often hard to treat. Phages are viruses that target bacteria, offering an alternative when bacteria have become resistant to antibiotics — a growing problem with treatment for CF as well as many other diseases.

People with CF who experience recurrent infections with P. aeruginosa show a steeper decline in lung function and a higher number of pulmonary exacerbations, or episodes of acute worsening of respiratory symptoms. They’re also more likely to be admitted to the hospital.

BX004, a phage cocktail inhaled into the lungs through a nebulizer, has been tested in a two-part Phase 1b/2a clinical trial (NCT05010577) that focused on its safety and tolerability. That study also showed that BX004 outperformed a placebo in improving lung function and reducing the number of P. aeruginosa bacteria, without any signs of resistance.

BiomX’s acquisition of APT will create a leading phage company with diverse technologies and an advanced clinical pipeline.

The planned Phase 2b clinical trial is designed to enroll about 60 CF patients with chronic lung infections caused by P. aeruginosa bacteria. The participants will be randomly assigned at a 2:1 ratio to either BX004 or the placebo twice daily for eight weeks, or about two months.

As well as continuing to monitor the safety and tolerability of BX004, researchers will test how well the phage cocktail reduces the number of P. aeruginosa bacteria and improves clinical parameters such as lung function and patient-reported outcomes. 

The U.S. Food and Drug Administration in January granted orphan drug status to BX004 as a CF treatment candidate. That designation offers incentives such as exemption from FDA application fees and seven years of market exclusivity if BX004 is approved.

The merger also plans to put efforts into advancing BX211, a phage therapy for diabetic foot osteomyelitis, or bone infection, caused by Staphylococcus aureus bacteria. BX211 is under Phase 2 clinical testing, and data readouts are expected in early 2025.

“With important data readouts for two programs expected in 2025, the funding from this transaction is designed to provide multiple opportunities to create stockholder value by reaching critical inflection points in each program’s clinical development,” Leff said.

Greg Merril, APT’s founder and board director, said the merger will benefit both therapy development programs.

“With the combined intellectual and financial resources coming from this acquisition, we now have a clear line of sight towards applying this ground-breaking technology to reach multiple data readouts in CF and [diabetic foot ulcers] over the next 12–24 months,” Merril said.

Following the deal, BiomX will continue to be led by its current management team, with Michael Billard from APT taking on the role of general manager for the U.S. Merril and Leff will serve on the board of directors.