A shortcut to patients when time was the scarcest resource
In October 2020, as the world searched urgently for tools to blunt the force of a pandemic, Brazil's health regulator opened a door for an American pharmaceutical company to test a promising antiviral on its own soil. Sorrento Therapeutics received Anvisa's approval to conduct phase 2 trials of Abivertinibe among 400 Brazilians in the early stages of COVID-19 infection — a moment that spoke to both the desperation of the era and the enduring human impulse to meet suffering with science. With vaccines still months away and effective treatments scarce, the trial represented a small but meaningful step in the long effort to give medicine something to offer before illness deepens.
- With Brazil among the world's hardest-hit nations and no widely available treatment in sight, the pressure to find early-stage interventions was acute.
- Anvisa's approval of a 7-day Abivertinibe protocol for 400 patients marked a regulatory breakthrough that cleared the path for large-scale human testing.
- Sorrento moved quickly to avoid the slow grind of building local infrastructure, partnering with Synova Health and its existing network of Brazilian medical centers.
- Rio de Janeiro emerged as a focal point for patient recruitment, with the local partnership expected to accelerate enrollment significantly.
- Sorrento signaled confidence beyond this single trial, with additional studies already under Anvisa review and the company framing Brazil as a cornerstone of its broader clinical strategy.
In October 2020, Brazil's health regulator Anvisa authorized American pharmaceutical company Sorrento Therapeutics to begin phase 2 clinical trials of Abivertinibe, an experimental COVID-19 treatment, on Brazilian soil. The trial would focus exclusively on patients in the early stages of infection, who would receive the drug over seven consecutive days. Sorrento aimed to enroll 400 volunteers across the country.
Rather than building its own local infrastructure from scratch, Sorrento partnered with Synova Health, a Brazilian clinical research organization with deep ties to the country's medical system. That network proved especially valuable in Rio de Janeiro, where the company expected to move quickly on patient recruitment.
The timing gave the moment particular weight. Effective COVID-19 treatments remained scarce in late 2020, and vaccines were still months from broad availability. A drug capable of intervening in the early window of disease — when outcomes are often most malleable — represented a genuine addition to the medical toolkit. Anvisa's approval signaled that preliminary evidence of safety and efficacy was sufficient to justify testing at scale. Sorrento, for its part, expressed confidence that the partnership would support not only this trial but additional studies already awaiting regulatory review.
In October 2020, as the world was still grappling with the COVID-19 pandemic, Brazil's health regulator gave the green light for a new experimental treatment to be tested on Brazilian patients. The Anvisa, Brazil's National Health Surveillance Agency, authorized Sorrento Therapeutics, an American pharmaceutical company, to move forward with phase 2 clinical trials of a drug called Abivertinibe.
The drug itself was designed to treat COVID-19 patients, though for this Brazilian trial, the scope would be narrower: only patients in the early stages of infection would receive it. Those who enrolled would take the medication for seven consecutive days. The trial design was straightforward in its ambition—Sorrento aimed to recruit 400 volunteers across the country.
To make that recruitment happen quickly, the company didn't go it alone. Sorrento partnered with Synova Health, a local clinical research organization with established relationships across Brazil's medical system. This connection proved strategic. Synova's existing network of medical centers meant the company could tap into patient populations without having to build those relationships from scratch. The partnership was particularly valuable in Rio de Janeiro, where Sorrento saw opportunity to accelerate enrollment.
The company's confidence was evident in its public statements. Sorrento framed the Brazilian trial as part of a broader clinical development strategy, emphasizing what it called a "broad strategic alignment" between itself and local medical systems. The company believed this infrastructure would allow it to not only launch the current trial quickly but also position itself for additional studies that were already under review by Anvisa.
What made this moment significant was the timing. In late 2020, effective COVID-19 treatments were still scarce. Vaccines were months away from widespread availability. Any drug that showed promise in early-stage disease—the window when interventions are often most effective—represented a genuine advance in the toolkit available to doctors and patients. Brazil, as one of the world's hardest-hit countries by the pandemic, was a logical place to test such a treatment. The regulatory approval from Anvisa signaled that the agency believed the drug had enough preliminary evidence of safety and efficacy to warrant human testing at scale.
Notable Quotes
A broad strategic alignment of clinical development between Sorrento and local medical systems, including Rio de Janeiro, will help accelerate the trial and access to potential patients for additional studies under Anvisa review— Sorrento Therapeutics
The Hearth Conversation Another angle on the story
Why did Sorrento choose Brazil specifically for this phase 2 trial?
Brazil was being devastated by COVID at that moment, and the country had the medical infrastructure to run a proper trial. But more practically, Sorrento needed patients fast, and Synova Health gave them access to hundreds of potential volunteers through existing medical networks.
Seven days seems like a short treatment window. What was the thinking there?
Early-stage disease is when antivirals tend to work best—before the virus has deeply entrenched itself. Seven days was probably designed to be both feasible for patients and long enough to measure whether the drug was actually doing something.
Did the partnership with Synova Health actually matter, or was it just logistics?
It mattered enormously. Without those existing relationships with medical centers, recruiting 400 volunteers in a reasonable timeframe would have been nearly impossible. Synova essentially gave Sorrento a shortcut to patients.
What happens if the trial works?
If Abivertinibe showed efficacy and safety in these 400 patients, Sorrento had already indicated it wanted to run additional studies. The Anvisa approvals were already in the pipeline.
And if it doesn't work?
Then it becomes one of thousands of compounds that didn't pan out. But in 2020, when treatments were scarce, the attempt itself was valuable.