Sorrento Completes Successfully the SAD Study and Initiates the MAD Phase 1 Study with STI-1558, An Oral M(pro) Inhibitor as a Standalone Treatment and Prevention of COVID-19 without the Ritonavir as Booster


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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Helixmith Announces Topline Results from Double-Blind Placebo Controlled Multicenter Study for TADIOS Involving 100 Subjects Infected with COVID-19


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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Enanta Pharmaceuticals Announces Positive Data from a Phase 1 Clinical Study of EDP-235, its Oral 3CL Protease Inhibitor Designed for the Treatment of COVID-19


– 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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Adamis Pharmaceuticals Provides Update on Clinical Study Assessing Tempol for the Treatment of COVID-19


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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Sorrento Therapeutics Announces the FDA IND Clearance of STI-1558, An Oral M(pro) and Cathepsin L Inhibitor to Treat COVID-19


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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Blue Lake Biotechnology Announces First Participant Dosed in a Phase 1 Clinical Trial of Its BLB-201 Intranasal RSV Vaccine


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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CHMP Adopts Positive Opinion Recommending Veklury® (Remdesivir) Receive Full Marketing Authorization for the Treatment of Patients With COVID-19


— 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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Health Canada Authorizes Moderna’s COVID-19 Vaccine in Young Children (6 Months-5 Years)


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…

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Immunome’s COVID-19 Cocktail Retains Neutralizing Activity Against the Most Prevalent Omicron Subvariants* in the US, BA.4/5 and BA.2.12.1


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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Vaxart Announces Agreement with hVIVO to Develop World’s First Human Omicron Challenge Model


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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