COVID-19
Single ascending dose (SAD) Phase 1 Study completed in Australia with a maximum dose of 2,000 mg. Pharmacokinetics (PK) were dose proportional and PK modeling and preclinical data support a 600 mg twice daily dose. There were no serious AEs (SAEs) or severe TEAEs and the maximum tolerated dose (MTD) was not reached. Initiation of…
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KEY POINTS TADIOS was determined to be safe and well tolerated Serum levels of IL-1RA changed significantly, a biomarker that has a correlation with severity and mortality during COVID-19 infections Improvement in fatigue observed Excerpt from the Press Release: LA JOLLA, Calif., Aug. 3, 2022 Helixmith announced topline results today from the double-blind placebo controlled…
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– 200mg and 400mg Once-Daily Doses Achieved Strong Exposure Multiples Over EC90 and Were Generally Safe and Well-Tolerated – Plan to Initiate Phase 2 Study in 4Q 2022 Excerpt from the Press Release: WATERTOWN, Mass.–(BUSINESS WIRE)–Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating novel, small molecule drugs for viral infections and liver…
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Interim DSMB review expected in late September Excerpt from the Press Release: SAN DIEGO, July 29, 2022 (GLOBE NEWSWIRE) — Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today provided an update on the Company’s ongoing U.S. Phase 2/3 clinical trial to evaluate the safety and efficacy of Tempol as a treatment for COVID-19. The next Data Safety Monitoring Board…
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STI-1558, an oral SARS-CoV-2 main protease inhibitor which can block viral replication, is specifically designed as a standalone treatment of COVID-19. Studies to date indicate that STI-1558 does not require the co-administration of ritonavir as a booster for CYP3A4 inhibition. STI-1558 is also a Cathepsin L inhibitor, which can block effective viral entry into host…
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Excerpt from the Press Release: ATHENS, Ga. and LOS GATOS, Calif., July 21, 2022 /PRNewswire/ — Blue Lake Biotechnology, Inc., a clinical-stage biotechnology company developing vaccines using a proprietary transformational parainfluenza virus 5 (PIV5)-based vector, today announced the enrollment of the first participant in a Phase 1 clinical trial of their intranasal BLB-201 vaccine for RSV (respiratory syncytial virus)…
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— If Granted by the European Commission, Veklury will Become the Only Direct-Acting Antiviral with Full Marketing Authorization in the EU — Excerpt from the Press Release: FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Commission (EC) adopted a positive…
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Two-dose series takes one month to complete, with similar vaccine efficacy estimates against Omicron to those seen in adults Excerpt from the Press Release: CAMBRIDGE, MA / ACCESSWIRE / July 14, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Health Canada has approved the use of…
Read More IMM-BCP-01 neutralized BA.4/.5 and BA.2.12.1 subvariants in pseudovirus testing IMM-BCP-01 currently in Phase 1b clinical testing with topline data expected in 2H 2022 Excerpt from the Press Release: EXTON, Pa.–(BUSINESS WIRE)–Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, today announced that…
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Model will be used in Vaxart’s Phase II Omicron Challenge Trial Open Orphan subsidiary hVIVO to manufacture challenge virus and conduct characterization study Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., June 30, 2022 (GLOBE NEWSWIRE) — Vaxart, Inc. (Nasdaq: VXRT) today announced an agreement with hVIVO Services Limited, a subsidiary of Open Orphan…
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