Enrollment completed for phase 3 trial of new gonorrhea antibiotic

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Gonorrhea bacteria

The Global Antibiotic Research & Development Partnership (GARDP) and Innoviva Specialty Therapeutics announced yesterday that they have completed enrollment for a phase 3 trial of an investigational antibiotic for uncomplicated gonorrhea infections.

The trial is evaluating the efficacy of oral zoliflodacin against Neisseria gonorrhoeae infections in comparison with the standard regimen of ceftriaxone plus azithromycin. A total of 958 patients have been recruited from 16 sites in five countries (Belgium, the Netherlands, South Africa, Thailand, and the United States) since November 2019. GARDP says it's the largest clinical trial ever for a new gonorrhea treatment.

It brings us one step closer to developing a new treatment for gonorrhoea.

Gonorrhea is one of the three most common sexually transmitted infections in the world, with an estimated 82 million infections each year. Although the current antibiotic regimen remains largely effective, it is the last remaining treatment option for N gonorrhoeae, a bacterium that develops resistance quickly and has burned through several antibiotics.

Zoliflodacin is a first-in-class antibiotic with a different mechanism of action against N gonorrhoeae than currently available therapies. In a small phase 2 trial, it was found to be highly effective in treating patients with urogenital and rectal gonorrhea infections and was well-tolerated.

Agreement with Entasis Therapeutics

In 2019, GARDP signed an agreement with drug developer Entasis Therapeutics (now a subsidiary of Innoviva) to sponsor the phase 3 trial and in return receive the rights to register and commercialize zoliflodacin, upon approval, in all low- and middle-income countries. Innoviva retains the commercial rights in the major markets in North America, Europe, Asia-Pacific, and Latin America.

"Completing the recruitment for the zoliflodacin phase 3 trial marks a significant milestone for us as it is the first antibiotic trial fully funded and sponsored by a non-profit like the Global Antibiotic Research & Development Partnership," GARDP  Executive Director Manica Balasegaram, MRCP, MSc, said in a press release. "It brings us one step closer to developing a new treatment for gonorrhoea, which is rapidly becoming resistant to existing antibiotics."

Topline results from the trial are expected later this year.

Excess deaths decreased in second pandemic year, likely tied to vaccination

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COVID memorial Washington monumentA new analysis of US national data reveals that excess deaths declined from 655,735 during the first pandemic year to 586,505 in the second. The study is published in the American Journal of Epidemiology.

Excess deaths were calculated from national and state-level data from 2009 to 2022. Between March 2020 and February 2021, 655,735 (95% confidence interval [CI], 619,028 to 691,980) excess deaths were estimated. Between March 2021 and February 2022. 586,505 (95% CI, 532,823 to 639,205) excess deaths were seen.

The authors of the study then analyzed excess deaths in states with low, medium, and high COVID-19 vaccination rates, defined as those in which less than 60%, 60% to 70%, and 70% or more of the population had received two doses of an mRNA vaccine or the single-dose Johnson & Johnson vaccine by April 2022.

Excess deaths were 22%, 22%, and 25% above baseline in low-, medium-, and high-vaccination states in the first year of the pandemic, but 23%, 22%, and 16%, respectively, in the second. There were 55,000 more excess deaths in high- than in low-vaccination states in year 1, but 35,000 fewer in year 2, wrote the author, economist Christopher Ruhm, PhD, of the University of Virginia.

The decline in excess deaths for seniors was almost certainly related to their rapid uptake of vaccinations.

Reductions in excess deaths in year 2 were also seen among Hispanics, Blacks, and Asian Americans. The authors explained this was likely because minorities were initially much more susceptible to COVID-related deaths in the beginning of the pandemic.

Those over the age of 65 also saw a dramatic reduction in excess deaths in year 2.

"The decline in excess deaths for seniors was almost certainly related to their rapid uptake of vaccinations," Ruhm wrote. "With particularly sharp fatality reductions among nursing home residents when vaccines became available."

Cookie dough-linked Salmonella outbreak sickens people in 6 states

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Papa Murphy's cookie dough

The Centers for Disease Control and Prevention (CDC) yesterday said federal and state health officials are investigating a Salmonella Enteritidis outbreak linked to cookie dough sold at Papa Murphy's pizza outlets that has so far sickened at least 18 people in six states.

Two people were hospitalized, and no deaths have been reported. States reporting cases are Washington (6), Idaho (4), Oregon (4), Utah (2), California (1), and Missouri (1). The earliest illness-onset date is February 27, and the most recent patient's illness began on May 2.

The true number of sick people is likely much higher, given that many people recover without medical care and aren't tested. Whole-genome sequencing on samples from the CDC's PulseNet system found that bacteria from the sick patients are closely related, suggesting that they were sickened by the same food.

Of 14 people who were interviewed about their food exposures, 12 said they ate food from Papa Murphy's, including 9 who ate raw cookie dough and 1 who had baked chocolate chip cookies made with the dough. The CDC said at least 2 of the sick people did not eat at Papa Murphy's, and investigators are working to identify the contaminated ingredient in the raw cookie dough.

Papa Murphy's has not recalled the cookie dough but has temporarily stopped selling their raw chocolate cookie dough and raw s'mores bars dough.

Several foodborne illness outbreaks in the past have been linked to eating raw cookie dough. The CDC said most raw dough is made with unpasteurized eggs and raw flour that can harbor Salmonella or Escherichia coli. The agency added, however, that some companies make edible dough with heat-treated flour, pasteurized eggs, or no eggs. "Read the label carefully to make sure the dough is meant to be eaten without baking or cooking," the CDC said.

World Health Assembly considers global preparedness, WHO's role in emergencies

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Delegates meeting at the World Health Assembly (WHA) in Geneva this week are discussing several topics related to infectious diseases and outbreaks, including the critical role the World Health Organization (WHO) plays in emergency response. The event, attended by health ministers from 194 member states, began on May 21 and runs through May 27.

Earlier this week, the group approved a draft proposal spelling out the WHO's work plan over the next 2 years and agreed on a $6.83 billion budget that includes a record 20% rise in contributions assessed to countries—part of an effort to make funding more sustainable. In addition to its main priorities, which includes health emergencies activities, the budget includes money targeting polio eradication, special programs, and emergency operations and appeals.

Yesterday the group received a report from the independent group that reviews the actions of the WHO's health emergencies committee, which found that the work was excellent, but that the program is underfunded and overstretched.

Today delegates are considering a resolution to increase access to medical oxygen in the wake of severe shortages that cost lives during the worst pandemic months. At a high-level meeting today health officials from health groups and nongovernmental organizations launched the new Global Oxygen Alliance, an outgrowth of the WHO taskforce that is designed to speed global and country efforts to improve oxygen access. The efforts will center around local oxygen production for use during emergencies.

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