As mpox has now been found in the EU, the race for an effective vaccine has accelerated, with a study failure but increased vaccine production from Europe. The U.S. NIH just released top-line results from a preliminary analysis of a placebo-controlled study of Siga Technologies Inc.’s antiviral, tecovirimat, showing it missed the primary endpoint of statistically significant improvement within 28 days post-randomization in time to lesion resolution for patients in the Democratic Republic of the Congo.
In response to the continuing opioid epidemic, researchers at the Massachusetts Institute of Technology and Brigham and Women’s Hospital developed a small implantable device that monitors heart rate, respiration and other vital signs indicative of an overdose, then automatically releases a dose of naloxone.
Preliminary results from a phase II study of Verrica Pharmaceuticals Inc.’s oncolytic peptide for basal cell carcinoma showed half of the participants had lesions reach complete histologic clearance with no tumor cells left behind. Those who still had tumors saw them shrink 71%. Every participant that received the treatment had a tumor-size reduction of 86%.
With favorable data from the phase III trial testing izokibep, a small protein therapeutic designed to inhibit IL-17A, in hidradenitis suppurativa (HS), Acelyrin Inc. CEO Mina Kim said the firm will “look at all the options and do what’s best for the program.” The phase III trial hit its primary endpoint of Hidradenitis Suppurativa Clinical Response 75 at 12 weeks. At the same time, the Los Angeles-based firm made known a refocused pipeline strategy that prioritizes lonigutamab in thyroid eye disease (TED) and is projected to extend its cash runway.
In response to the continuing opioid epidemic, researchers at the Massachusetts Institute of Technology and Brigham and Women’s Hospital developed a small implantable device that monitors heart rate, respiration and other vital signs indicative of an overdose, then automatically releases a dose of naloxone.
Data from an interim analysis have convinced Syros Pharmaceuticals Inc. to stop enrollment in its phase II study of treating newly diagnosed acute myeloid leukemia (AML) and retinoid alpha receptor agonist gene overexpression. Analysts seemed unconcerned about the repercussions for Syros’ phase III study in myelodysplastic syndrome.
Visen Pharmaceuticals Co. Ltd.’s palopegteriparatide met both primary and secondary endpoints in the phase III Pathway trial conducted in China in adults with chronic hypoparathyroidism, according to top-line data. In the 26-week randomized, double-blind, placebo-controlled Pathway trial, 77.6% of patients treated with palopegteriparatide achieved the primary multicomponent endpoint compared to 0% for placebo.
Neuren Pharmaceuticals Ltd.’s NNZ-2591 met the primary endpoints in a phase II trial in children with Angelman syndrome, with improvements seen in clinically important aspects of the disease, including communication, behavior, cognition and motor abilities, Neuren CEO Jon Pilcher said during an Aug. 9 conference call.
China’s National Medical Products Administration has cleared Luye Pharma Group Ltd.’s new schizophrenia candidate LY-03020 to enter phase I trials in China. Independently developed by Shanghai-based Luye, the new chemical entity is a dual agonist that targets both the trace amine-associated receptor 1 and the 5-HT2C receptor and is intended to treat schizophrenia and Alzheimer’s disease psychosis.
An artificial intelligence algorithm developed at Sheba Medical Center in Israel can identify patients at high risk of pulmonary embolism as soon as they walk through the hospital doors, a study published in the Journal of Medical Internet Research found. Using only information available from the patient’s medical history, the machine learning tool flagged high-risk patients before the initial clinical checkup occurred.
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