Moderna has announced a supply agreement with the Government of The Philippines for 13M doses of the COVID-19 Vaccine Moderna. Under the terms of this agreement, deliveries would begin in mid-2021. The COVID-19 Vaccine Moderna is not currently approved for use in the Philippines, and the company will work with regulators to pursue necessary approvals prior to distribution. A separate agreement with the Philippine Government and private sector for the supply of an additional 7M doses is also anticipated.

Gilead Sciences announced new, long-term data from open-label extensions of two Phase 3 studies of Biktarvy, demonstrating the sustained efficacy and safety profile and no treatment-emergent resistance with Biktarvy for the treatment of HIV-1 in treatment-naive adults. The data were presented at the 28th Conference on Retroviruses and Opportunistic Infections. In both studies, greater than 98% of participants who initiated treatment with Biktarvy and remained in the study achieved and maintained an undetectable viral load through four years of follow-up. The high efficacy and durable viral suppression were also observed in participants who switched to Biktarvy from a dolutegravir-containing triple therapy for the 48-week OLE periods. No treatment-emergent resistance to any components of Biktarvy occurred in participants treated with Biktarvy. Gilead presented additional Biktarvy data at virtual CROI 2021, including findings from a 144-week analysis of the same Phase 3 studies, which demonstrated that people living with HIV who received initial therapy with Biktarvy reached and maintained an undetectable viral load with no treatment-emergent resistance through 144 weeks. In a subgroup analysis of participants with transmitted-drug resistance based on retrospective sequencing of baseline samples, Biktarvy achieved comparably high levels of durable viral suppression through 144 weeks among participants with and without TDR.

Atea Pharmaceuticals presented results from the Phase 1 study of AT-527 in healthy volunteers at the 28th Annual Conference on Retroviruses and Opportunistic Infections in a Science Spotlight presentation. AT-527 is an orally administered, direct-acting antiviral developmental agent derived from Atea's purine nucleotide prodrug platform and is in Phase 2 clinical development for the treatment of COVID-19. AT-527 targets SARS-CoV-2 ribonucleic acid polymerase, a highly conserved gene which is responsible for both viral RNA replication and transcription. Given this preferential conserved target site, it is anticipated that the antiviral activity of AT-527 will continue even in the presence of naturally-evolving variants which are now emerging. In the Phase 1 study, 20 healthy volunteers were randomized 1:1 to receive oral AT-527 550 mg twice daily or matching placebo for 5 days. The purpose of this study was to assess the safety and pharmacokinetics of AT-527 in healthy volunteers and to predict human lung exposure of intracellular AT-9010, the active triphosphate metabolite of AT-527. Safety assessments included adverse events, vital signs, electrocardiograms, and standard safety laboratory tests. Intensive PK sampling, performed after the first and last two doses, provided information on plasma exposures of AT-511, the free base of AT-527, a hemisulfate salt, and its metabolites including AT-273, the guanosine nucleoside metabolite, a measurable surrogate for intracellular AT-9010. The study results showed AT-527 was well tolerated with a favorable safety profile. There were no discontinuations, serious AEs, clinically significant changes in vital signs, or ECGs observed. The data also demonstrated that AT-511 was rapidly absorbed, followed by fast and extensive stepwise metabolic activation ultimately to the intracellular TP metabolite AT-9010, reflected by plasma AT-273. AT-527 550 mg BID led to fast attainment of steady-state levels of AT-273 within two days of dosing. Plasma levels of AT-273 were further used to predict lung concentrations of AT-9010 using a scaling factor of 1.2X which was previously determined from in vivo tissue distribution of the triphosphate metabolite in cynomolgus monkeys. Beginning as early as three hours after the first dose, and maintained thereafter throughout the five days of dosing, predicted lung AT-9010 levels were consistently above the EC90 level of 0.5 microM for in vitro inhibition by the drug of SARS-CoV-2 replication. These results indicate the potential of AT-527 for the treatment of COVID-19 and are supportive of the dosing regimen of 550 mg BID.

Merck and Ridgeback Biotherapeutics announced preliminary results from Ridgeback's Phase 2a randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, and efficacy to eliminate SARS-CoV-2 viral RNA of molnupiravir, an investigational oral antiviral agent. The companies reported findings on one secondary objective from the Phase 2a study, showing a reduction in time to negativity of infectious virus isolation in nasopharyngeal swabs from participants with symptomatic SARS-CoV-2 infection, as determined by isolation in Vero cell line culture. Findings from the primary efficacy and safety endpoints and additional secondary objectives will be presented at an upcoming medical meeting. This multi-center U.S. Phase 2a study enrolled 202 non-hospitalized adults who had signs or symptoms of COVID-19 within 7 days and confirmed active SARS-CoV-2 infection. The primary efficacy objective was reduction in time to viral negativity measured by reverse transcriptase polymerase chain reaction analysis of nasopharyngeal swabs. Periodic samples were collected for virologic analysis. Of the 182 participants with an evaluable nasopharyngeal swab, 42% showed detectable levels of cultured virus at baseline. Other Phase 2 and Phase 2/3 studies are underway. Of 202 treated participants, no safety signals have been identified and of the 4 serious adverse events reported, none were considered to be study drug related.