News Scan for Mar 25, 2020

New antibiotic collaboration
Brazil's dengue vaccine candidate
Low-path H7N3 avian flu in US turkeys

Forge, Hoffman-La Roche partner on antibiotic for lung infections

Forge Therapeutics announced today that it will partner with Hoffman-La Roche to develop and commercialize a novel antibiotic for treating serious lung infections caused by antibiotic-resistant gram-negative bacteria.

The antibiotic, developed by Forge through its Fg-LpxC LUNG program, targets and inhibits LpxC, a zinc metalloenzyme found in gram-negative bacteria, using a proprietary chemistry platform.

Forge, which received funding for the program from CARB-X (the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator) in 2019, says its LpxC inhibitors have been found safe and effective in animal models and are being optimized for lung infections, including those caused by Pseudomonas aeruginosa.

Under the terms of the agreement, Forge will retain control of the Fg-LpxC LUNG program until Hoffman-La Roche exercises its exclusive option to license the program. Forge is eligible to receive up to $190.5 million in total payments.

"We look forward to combining our novel approach and innovative chemistry with Roche’s proven drug development and commercialization expertise to provide a truly new class of antibiotic for people suffering from serious antibiotic-resistant infections," Forge CEO Zachary Zimmerman, PhD, said in a company press release.
Mar 25 Forge Therapeutics press release


Phase 2 trial of Brazil's dengue vaccine yields favorable results

The Butantan Institute's lyophilized (freeze-dried), tetravalent (four-strain), live-attenuated dengue vaccine is safe and produces a "robust, balanced" antibody response, according to the results of a randomized, controlled, phase 2 trial yesterday in The Lancet Infectious Diseases.

In the two-step, double-blind trial, researchers randomly assigned 300 healthy volunteers 18 to 59 years old to receive one of two vaccine regimens involving Butantan-DV at two sites in Sao Paulo, Brazil, from Nov 5, 2013, to Sep 21, 2015. Butantan is headquartered in Sao Paulo.

In the first step, 155 people (52% of the volunteers) who had never had dengue fever received two doses of Butantan-DV, Merck's TV003 (a comparable vaccine), or a placebo 6 months apart. In the second step, 145 participants (48%) who had had dengue received one dose of Butantan-DV or a placebo.

Of the 155 dengue-naive subjects, 97 (63%) received Butantan-DV, 17 (11%) received TV003, and 41 (27%) received a placebo. Of the 145 dengue-exposed subjects, 113 (78%) received Butantan-DV, 3 (2%) received TV003, and 29 (20%) received a placebo.

Both Butantan-DV and TV003 produced an immune response and caused no serious adverse reactions, according to the report. In the first group, rash was the most common adverse event, reported by 16 (84%) of 19 participants receiving Butantan-DV and 13 (76%) of 17 participants receiving TV003.

Of the 85 dengue-naive participants who received Butantan-DV and completed the protocol and were included in the analysis, 74 (87%) produced protective antibodies to dengue 1, 78 (92%) to dengue 2, 65 (76%) to dengue 3, and 76 (89%) to dengue 4.

Of the 101 dengue-exposed participants who received Butantan-DV and completed the protocol, 82 (81%) produced protective antibodies to dengue 1, 79 (78%) to dengue 2, 83 (82%) to dengue 3, and 78 (77%) to dengue 4. The effectiveness of Butantan-DV is now being tested in phase 3 trials.

TV003 also produced good results in the trial. The study was a result of a collaboration between Merck and the Butantan Institute announced in 2018.

Dengue, which is endemic in more than 100 countries, causes 50 million to 100 million cases and 9,000 to 20,000 deaths each year.
Mar 24 Lancet study

Mar 24 Lancet commentary


Low-path H7N3 avian flu strikes more turkey farms in the Carolinas

The US Department of Agriculture (USDA) has reported eight more low-pathogenic H7N3 avian influenza outbreaks at turkey farms in two states, according to a notification yesterday from the World Organization for Animal Health (OIE).

The report follows an initial report on Mar 16 of three outbreaks at turkey farms in Union County, North Carolina. Of the latest outbreaks, seven are in already affected Union County (6) and Anson County (1) in North Carolina and one is Chesterfield County in South Carolina, south of the other two counties. The outbreaks began between Mar 13 and Mar 19, and 188,829 turkeys were culled to control the spread of the virus.

The outbreaks were identified through enhanced surveillance. So far, the source of the virus isn't known.
Mar 24 OIE report
Mar 19 CIDRAP News scan "Avian flu outbreaks strike poultry in North Carolina, the Philippines"

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