A: Yes! Three happy pieces of news this week:
(1) The launch of an early-stage clinical trial for what’s believed to be the world’s first antibody treatment against COVID-19;
(2) A Stat News interview with Dr. Fauci showcasing his cautious optimism about vaccine development;
(3) New data on the anti-viral Remdesivir indicating the treatment’s effectiveness for moderately sick patients.
More context:
FIRST COVID-SPECIFIC ANTIBODY TREATMENT LAUNCHED INTO CLINICAL TRIALS
Eli Lilly announced yesterday (6/1) that it’s launched a Phase I (aka: very early) trial to test the safety and tolerability of a brand-new potential treatment against COVID-19 (see link below for more info). It’s believed to be the world’s first antibody treatment developed specifically to fight COVID-19. A quick refresher: antibodies are protective proteins produced by the body’s immune system to fight off “invaders.” To date, we’ve heard lots about antibody TESTING – which assesses the presence of a past infection – now we can get ready to hear more about antibody TREATMENTS. Lilly’s experimental treatment is the first of what’s likely to be many candidate antibody treatments; Regeneron, for example, is launching a trial of a “cocktail” (aka combo) of antibody treatments later this month. It’s important to note that these are very early phase studies, and will NOT be able to speak to the drug’s effectiveness, only its safety and tolerability. So why the optimism? The launch of these trials signals that INNOVATION is happening at warp speed! And even though we don’t want to be overly Pollyana-ish about any given potential treatment, it’s perfectly reasonable to be heartened by the broader collective of potential treatments currently in the hopper. (For more info on antibody treatments, please seek HuffPo link below).
FAUCI’S OPTIMISM ON THE VACCINE FRONT
In an in-depth and insightful interview with Stat News’ amazing, tour-de-force infectious disease journalist Helen Branswell, Dr. Anthony Fauci shares his perspective on vaccine development (link at bottom). TL;DR: He’s (cautiously) optimistic, suggesting that if all goes well a “significant number of doses” could be available by the beginning of 2021. He is transparent about two potential rate-limiters: (1) If everything does not indeed go well (to state the obvious :)); (2) efficacy of the vaccine in protecting against COVID-19 remains an open question and his greatest concern.
NEW DATA ON REMDESIVIR INDICATES BENEFIT IN HOSPITALIZED PATIENTS
Yesterday, Gilead released new data from a randomized clinical trial of almost 600 hospitalized patients with moderate COVID-19 symptoms – demonstrating that patients randomized to receive the anti-viral Remdesivir + standard of care experienced better clinical outcomes than patients randomized to receive standard-of-care alone (link to Gilead press release below). No evidence of serious treatment side effects was found in the study sample. Why are these data powerful? RANDOMIZATION, RANDOMIZATION, RANDOMIZATION! By randomizing treatment status we can say with some confidence that the only differences in outcomes can be linked to the treatment itself. Additionally, the study has a sufficient SAMPLE SIZE to suggest that the findings are indeed “signal” and not merely artifacts of “statistical noise” inherent in small samples. So what’s needed next? More data about CONTEXT – do these findings generalize outside of the clinical settings in the study? Do they generalize to patients with varying severities of disease? We’ll all stay tuned for final study assessment once the data are published in a peer-reviewed journal article, which Gilead has committed to submitting in the coming weeks.
IN CONCLUSION
On the treatment/vaccine development front: Stay tuned, stay hopeful. We’ll continue to keep you updated as the science proceeds.
Links to articles:
Eli Lilly antibody drug in trials
HuffPo overview on antibody “cocktails”
Helen Branswell of Stat News interviews Dr. Fauci
RCT data indicate Remdesivir’s effectiveness in moderately ill patients
