Evercore ISI assembled a dozen internal specialists for a webinar to talk about COVID-19 from a variety of perspectives, with opinions aplenty on transmission route, up-and-coming treatment prospects, and problems in how testing procedures are understood – or not. “The more I read about this, the more it is clear that [the virus] is spread by the aerosolized route,” analyst Josh Schimmer said. Because the transmission route “was not clearly communicated at the beginning and still is not fully appreciated,” COVID-19 continues to spiral in the U.S. and the world, he said.

In terms of contagiousness, the virus is pretty much the same as measles, Schimmer said, though he acknowledged that many believe COVID-19 is less able to spread. “Two differences are that the word ‘measles’ locks people indoors faster than COVID-19, and we have vaccines for measles today.” Quarantining will help, he said, but “the challenge is going to be how do we emerge from this quarantine and get back to business as usual.” He said he is “more confident than I was before that [vaccines are] going to work,” though he is “keeping a watch on the other countries to see if maybe eradication could be possible before we get to the vaccines. Right now it’s looking tough, but not impossible.”

Analyst Umer Raffat counted 270-plus COVID-19 prospects in development, although the situation is “not as complex as it sounds,” as the candidates can be divided into three types – antivirals, anti-inflammatory therapies and vaccines – with “the focus right now on a drug that can be taken after someone’s infected.” Not surprisingly, hydroxychloroquine came up first. Although potent in preclinical findings, study results emerging from China have been mixed. “Every other day, you’ll read one study that’s positive and one study that’s negative,” he said.

With hydroxychloroquine, starting with a hefty amount early in treatment may be the key, in Raffat’s view. “The dosage being used in these studies is grossly under-appreciated,” he said, noting that his firm recently analyzed them, prompting “a lot of scientific-community attention on the topic.” Because effects take a few days to appear, “you need to start with a big loading dose up front, something that’s not been done in trials, which is why simply asking, ‘Did the drug work?’ is not a fair question. You have to ask, ‘Did you get to the right dose level right away?’” He conceded that Evercore’s staff is not made up of scientists or doctors, but said the best initial dose might land between 800 mg and 1,200 mg. At least two trials in China are using the 1,200-mg loading dose.

Raffat also likes remdesivir, the antiviral from Foster City, Calif.-based Gilead Sciences Inc. that is undergoing a phase III trial in 450 severe COVID-19 patients, also in China, from which results are “due any day,” he said. “My understanding is that it’s already been submitted for publication.” Another Gilead watcher with high hopes from the compound is SVB Leerink analyst Geoffrey Porges, who called remdesivir “the best prospect for a change in confidence about the medical and economic hazards posed” by the virus.

FDA-cleared serology assays ‘useless’

Porges wrote in an April 6 report that Gilead’s most recent update on clinical and manufacturing considerations “amount[ed] to the most complete disclosure investors have ever had about any drug development program, much less one proceeding on such an accelerated and impactful basis. Gilead’s board, management and their legal advisors are to be applauded for maintaining such transparency,” in his view. “Should remdesivir produce a 20-30% reduction in the mortality from COVID-19, or improve other markers of clinical progression such as ventilator days or residual morbidity, then the community at large (worldwide) is likely to breathe a huge sigh of relief at the prospect of making this disease more manageable medically and economically.” Data from the China study “could be a major catalyst for a change in sentiment in equity markets should the drug be effective,” he added.

Raffat sounded somewhat more cautious. “The overall trial may underwhelm, but if you look at a subgroup of patients that take the drug early enough, I think we may see a signal there,” he said during the webinar. “It's not going to solve or cure [the virus] overnight, but could it help patients recover better and faster? Perhaps, as long as you take it early enough. We’ll see how that shakes out.”

Meanwhile, in the realm of testing, a lack of comprehension reigns. Evercore consulted San Diego-based Genalyte Inc., which is working on Mobile Stat Labs, on-site testing centers designed to get the job done in about 20 minutes. The company has a screening panel due to roll out in April. “There is an incredible amount of misunderstanding on the utility of polymerase chain reaction (PCR) and serology testing,” Schimmer wrote in an April 4 report, after a separate webinar with Genalyte CEO Cary Gunn. “They can be used either for acute/recent infections or to assess immunity and protection against future infections. Those are very different applications, but many seem to be confusing them.” As a result, some policymakers and clinicians “are headed toward decisions which could have extremely deleterious consequences for people.” Serology can be used with PCR to diagnose active COVID-19 infection, “a reasonable but fairly limited application and most people aren’t even being diagnosed.” Such an approach is completely unlike screening a population for immunity to the virus. “Almost all of the serology assays being approved by the FDA have such poor performance that they’re essentially useless,” Schimmer wrote.

No Comments