FDA fast-tracks antibody treatment targeting bacterial biofilms

News brief

Biofilm illustration — Artur Plawgo / iStock

Clarametyx Biosciences said this week that its investigational antibody treatment for cystic fibrosis patients plagued by chronic bacterial lung infections will receive priority review and development incentives from the US Food and Drug Administration (FDA).

The company said in a press release that the FDA had granted CMTX-101, a monoclonal antibody designed to rapidly collapse bacterial biofilms, Fast Track and Qualified Infectious Disease Product (QIDP) designations under the Gaining Antibiotic Incentives Now Act. The two designations mean Ohio-based Clarametyx will get more frequent interactions with the agency, an expedited review process and potentially accelerated approval, and an additional 5 years of market exclusivity if CMTX-101 is approved.

"The receipt of both Fast Track and QIDP designations from the FDA underscores CMTX-101’s potential as an innovative therapy for patients suffering from chronic respiratory conditions," said Clarametyx CEO David Richards. "We look forward to working even closer with FDA to expedite the approval of a new therapy for patients suffering from difficult-to-treat pulmonary conditions."

Promising findings from early clinical trial

Bacterial biofilms are complex communities of microorganisms that serve as a protective coating for bacterial pathogens and make them highly resistant to antibiotics. CMTX-101 destroys the structure of biofilms by targeting a region of binding proteins that stabilize and maintain their integrity.

The proteins are nearly identical across all pathogenic bacteria, but Clarametyx is currently focusing on Pseudomonas aeruginosa, one of the most common causes of cystic fibrosis-related lung infections. The hope is that CMTX-101 can help improve the effectiveness of antibiotic therapies in cystic fibrosis patients.

Clarametyx is currently enrolling cystic fibrosis patients with P aeruginosa infections in a phase 1b/2a study evaluating the safety, tolerability, pharmacokinetics, and ability of CMTX-101 to help reduce the pulmonary P aeruginosa burden. Interim results released in June indicated patients who received CMTX-101 as an adjunctive to standard-of-care antibiotics had reduced P aeruginosa burden based on prespecified criteria, and that the drug was well-tolerated.

US measles cases and outbreaks continue steady rise

News brief

Lisa Schnirring

In a weekly update today, the US Centers for Disease Control and Prevention (CDC) reported 23 more measles cases, bringing the national total for the year to 1,356 cases, the most since the United States achieved measles elimination in 2000.

measles rash — *CDC / Heinz F. Eichenwald, MD*

One more state reported cases, Wisconsin, lifting the number of affected states to 41. Three more outbreaks were reported, putting the nation’s total at 32 for the year. For comparison, the country had 16 outbreaks for all of 2024.

Of confirmed illnesses this year, 87% were part of outbreaks, compared with 69% for 2024. And of infected patients, 92% were unvaccinated or had unknown vaccination status. Though about 65% of cases occurred in children, 34% were recorded in adults ages 20 years and older.

Latest activity a mix of outbreaks and travel-linked cases

Earlier in the outbreak, cases in the West Texas outbreak drove most of the activity, but since then smaller outbreaks in other states have accounted for many of the cases, along with infections linked to international travel. Some have involved travelers from other US states. For example, the New Mexico Department of Health on August 1 announced that a child from another state visited New Mexico while infectious and may have exposed people at locations in Santa Fe, including an art exhibit and a hotel.

Elsewhere, the Idaho Department of Health and Welfare recently reported that CDC-contracted testing has detected measles in a July 29 wastewater sample collected from Coeur d’Alene, though no confirmed or suspected measles cases have been reported from the Panhandle Health District.

The CDC said outbreaks of three or more cases continue to be reported, especially in communities with low vaccination coverage. It announced an upcoming Clinician Outreach and Communication Activity (COCA) Call for clinicians on August 14 to update clinicians on the latest measles epidemiology and to field questions from health providers on preventing, identifying, and testing for measles.

Cambodia announces 15th human H5N1 infection of the year

News brief

Lisa Schnirring

The steady pace of human H5N1 avian flu infections in Cambodia continues this week, with the health ministry today announcing another new case, the country’s 15^th of the year.

In a Facebook post, the ministry said the patient is a 6-year-old girl from Takeo province, according to a translation from Avian Flu Diary, an infectious disease news blog. The girl is hospitalized with symptoms that include fever, cough, and breathing difficulty. Cambodia’s National Institute of Public Health confirmed the case yesterday.

Sick and dead chickens in girl’s village and home

Takeo province is on Cambodia’s southern border. Investigators found that there were nearly 1,000 sick or dead chickens in the girl’s village over the past month, including at the child’s home, where there were 30 sick and dead chickens. Her mother had brought the dead chickens to cook shortly before the girl became ill.

Erik Karlsson, PhD, with the National Influenza Center and Pasteur Institute in Cambodia, said on X today that 7 of the 15 cases from Cambodia this year have been fatal, resulting in a case-fatality rate (CFR) of 46.6%. He added that since 2005 Cambodia has reported 87 cases, which include 50 deaths for a CFR of 57.5%.

Nearly all of Cambodia’s recent cases have involved contact with sick or dead poultry, and many of affected patients have had severe or fatal infections. The latest human cases have involved a reassortant (2.3.2.1e) between an older H5N1 clade that has circulated in Cambodia since 2014 and the newer clade 2.3.4.4b virus that is circulating globally. The rise in human cases began at the end of 2023 and has accelerated this summer, with 12 reported over the past 2 months.