About a year ago, when Seres Therapeutics Inc. won U.S. FDA approval of oral microbiome therapy Vowst (live fecal microbiota spores), the drug – meant to prevent recurrent Clostridioides difficile infection – was hailed as first in the space, and launch plans sounded ambitious. In July 2021, Seres inked a deal with Nestlé Health Science SA, of Lutry, Switzerland, to jointly commercialize Vowst in the U.S. and potentially Canada. But shares of Cambridge, Mass.-based Seres (NASDAQ:MCRB) closed May 8 at 75 cents, down 36 cents, or 32%, after the firm provided an update on sales, roughly flat quarter over quarter.
Sepsis occurs when there is a dysregulated host response to infection, resulting in organ dysfunction. According to the Global Burden of Disease study, about 50 million people annually worldwide develop severe sepsis or septic shock, and 11 million of them die. Growing evidence suggests that changes to the vascular endothelium, which becomes more permeable to fluid, protein and inflammatory cells, are behind the pathogenesis of sepsis and septic shock.
Memo Therapeutics AG has added a further CHF20 million (US$22 million) to its series C, bringing the total for the round to CHF45 million and enabling the company to expand the phase II trial of its lead program, AntiBKV, in neutralizing BK virus infection in immune compromised kidney transplant recipients.
Researchers from the University of Pittsburgh have developed a device designed to collect exhaled respiratory aerosols from mechanically ventilated patients. Their device is designed to be non-invasive, highly efficient and can be readily placed in the exhalation line of ventilators without interfering in the functions of the ventilator.
Despite what University of Pennsylvania (Penn) immunotherapy pioneer Carl June referred to as a “cold slap last November” – a launched investigation by the U.S. FDA into a possible link between CAR T-cell immunotherapies and secondary cancers – new unpublished studies by Penn and Stanford University highlight the rarity of such cases.
Less than a week ago, executives at Lyra Therapeutics Inc. were looking ahead to “imminent” data from its first phase III study in chronic rhinosinusitis (CRS), testing drug-device candidate LYR-210, a drug-device candidate largely expected to fill a much-needed gap in CRS treatment. On Monday, May 6, they were announcing plans to preserve cash in the wake of the failed Enlighten 1 study, which raised doubts as to the feasibility of the company’s CRS programs, which also include the similarly designed candidate LYR-220.
There is a compelling need to produce new antibiotics that hamper severe opportunistic infections, especially in immunocompromised individuals, such as those caused by gram-negative Pseudomonas aeruginosa.
Amicetin-inspired inhibitors of the P-site (AIIPS), also known as CZ-02s, are a series of molecules that target and inhibit a unique site of the bacterial ribosome.
Cytovale Inc. has posted a feverish run of wins lately. The company gained U.S. FDA clearance for its Intellisep rapid test for sepsis in January 2023, raised $84 million in a series C in November and just published results showing the test has negative predictive value of 97.5%.
Lyme disease, caused by the bacterium Borrelia burgdorferi, is the leading tick-borne infection. Between 10% and 35% of patients show post-antibiotic treatment Lyme disease syndrome, with symptoms including fatigue, cognitive issues, memory loss, neuropathy, joint pain, musculoskeletal pain, sleep issues, depression and others.
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