Elysium Therapeutics Inc. aims to tackle the problem of opioid overdose with a longer-lasting rescue agent that gets around the not-much-publicized problem of fentanyl rebound, or re-narcotization, which happens when the standard reverser wears off and the culprit drug stays active in the body, potentially killing the patient.
In part one of this story on Elysium Therapeutics Inc., published Aug. 14, company officials explained the rationale and technology behind the plan to formulate a longer-lasting opioid-overdose rescue agent – one that remedies the problem of fentanyl rebound, or re-narcotization, which happens when the standard reverser wears off and the culprit drug stays active, potentially killing the patient.
Elysium Therapeutics Inc. aims to tackle the problem of opioid overdose with a longer-lasting rescue agent that gets around the not-much-publicized problem of fentanyl rebound, or re-narcotization, which happens when the standard reverser wears off and the culprit drug stays active in the body, potentially killing the patient.
Quince Therapeutics Inc.’s mid-July completion of enrollment in the pivotal phase III study in ataxia-telangiectasia (A-T) marked an important milestone for the South San Francisco-based firm, which is not the only contender in the space. The study called NEAT – a rough acronym for “Neurological Effects of eDSP on Subjects with A-T” – will evaluate Quince’s lead asset, eDSP, in the neurodegenerative illness.
Insmed Inc. CEO William Lewis said that offering two doses of Brinsupri (brensocatib) will complicate payer coverage “not at all, just the opposite. It’s going to give the flexibility to physicians to choose how they want to engage with their patients, wrestle with whatever issues may be in their minds related to safety [and] what have you.” The U.S. FDA approved Insmed’s first-in-class dipeptidyl peptidase 1 inhibitor, Brinsupri, given in 10-mg and 25-mg tablets as a once-daily treatment for noncystic fibrosis bronchiectasis in adults and children 12 and older.
IO Biotech ApS will discuss this fall with the U.S. FDA the data package related to Cylembio (imsapepimut and etimupepimut, adjuvanted) after the off-the-shelf therapeutic cancer vaccine prospect missed “by a hair” the primary endpoint in a pivotal phase III melanoma trial, said CEO Mai-Britt Zocca.
Among the strong points of Nektar Therapeutics Inc.’s atopic dermatitis (AD) prospect, rezpegaldesleukin (rezpeg), an IL-2 pathway agonist and regulatory T-cell proliferator, is the drug’s faster onset of action – a feature that experts say may help differentiate the compound from competitors in the OX40 space.
The fibroblast growth factor 21 (FGF21) analogue space took another turn as Novo Nordisk A/S said during its second-quarter financial update that work with zalfermin (NNC0194-0499) will be discontinued. A phase II study testing the compound in combination with glucagon-like peptide-1 therapy failed to hit the primary endpoint related to liver fibrosis in metabolic dysfunction-associated steatohepatitis (MASH), without MASH worsening.
Vertex Pharmaceuticals Inc.’s bad news from a phase II pain study and separately on the regulatory front caused shares (NASDAQ:VRTX) to close Aug. 5 at $393.83, down $78.44, or 16%. Vertex rolled out top-line results from the phase II dose-ranging study to test the safety and efficacy of its NaV1.8 pain signal inhibitor, VX-993, in tackling acute pain after bunionectomy.
Novartis AG’s financial update included good news about Scemblix (asciminib), the first and only U.S. FDA-approved allosteric inhibitor for chronic myeloid leukemia (CML), which gained clearance in October 2021. The drug introduced a new mechanism of action by specifically targeting the ABL myristoyl pocket.
