In the fight against Covid-19, new antiviral medications that can be delivered orally as pills, such as Pfizer’s Paxlovid or Merck’s Molnupiravir, have the potential to transform a deadly pandemic into a manageable disease.
Now, an Israeli medical diagnostics startup is throwing its pharmaceutical hat into the antiviral ring.
Tollovir from Todos Medical just completed a double-blind, randomized placebo-controlled Phase 2 clinical study, which closed early after initial data showed positive efficacy among 31 hospitalized Covid-19 patients. Results showed clinical improvement 2.7 days faster than the placebo group. The drug was tested on the Alpha, Beta and Delta variants of Covid, but not on Omicron.
There were no Covid-related deaths in the Tollovir group vs. 22% Covid-related deaths in the placebo group. One Tollovir patient required mechanical ventilation.
At least one Israeli medical center, Shaare Zedek in Jerusalem, is now permitting Tollovir on a “compassionate use” basis.
The next step will be a Phase 2/3 clinical trial to support emergency use authorizations in the United States and Europe.
“We have already begun preparing manufacturing for commercial quantities of Tollovir so that we will be able to deliver shipments in jurisdictions where we expect to be granted accelerated emergency use authorization,” said Todos CEO Gerald Commissiong.
Tollovir is a 3CL protease inhibitor with strong anti-cytokine activity. Cytokine storms and cytokine release syndrome are life-threatening systemic inflammatory syndromes, often triggered by a virus such as Covid-19.
Discovered by Technion chemist Dorit Arad in 2004, 3CL protease inhibitors are enzymes that play an essential role in the replication of viruses such as SARS-CoV-2.
Todos was founded in Rehovot and has an office in New York City. The company entered a joint venture with NLC Pharma to develop both 3CL protease inhibitors and diagnostic tests that target the specific enzyme. Arad founded NLC Pharma in 2006 and currently serves at its CTO.
“The recent emergence of the Omicron variant has been pushing healthcare systems to the brink of collapse,” Arad said. “Tollovir could be an incredibly powerful tool to reduce death and stabilize patients faster, thereby reducing their recovery time from this debilitating disease. Tollovir will help flatten the curve by freeing up hospital capacity to see more patients and perform other more routine non-COVID related hospital treatments.”