Covicept Therapeutics Inc., a young San Diego-based company focused on developing a small molecule to inhibit the replication and spread of SARS-CoV-2 and other RNA viruses, has launched with $2.3 million in seed funding from European VC firm Forbion. The company, spun out of research at the University of California, San Diego (UCSD), aims to initiate its first clinical study in the middle of 2021.
Company co-founder and CEO Sam Tsimikas told BioWorld that Covicept got its start in July 2020 following the discovery, with his co-founders Philip Gordts and Jeffrey Esko, of a small molecule long ago found to have anti-infectious properties. Though they've not yet disclosed its name, when Gordts and Esko led lab work to test it against SARS-CoV-2 in cell culture and a preclinical animal model they found it incredibly potent, he said.
The compound was originally part of a cardiovascular-focused grant intended to illuminate macrophage epigenetics in the context of inflammation. But, "like a lot of things in life, there's always a little bit of serendipity involved," something helped by having a mind prepared for new things, said Tsimikas, who like his co-founders, is also a UCSD professor. In addition to being chair of Covicept’s board, Tsimikas also works part time at Ionis Pharmaceuticals Inc.
Since a toxicology package and phase I trial of the molecule were already completed in a prior indication, "we feel we can go right to phase II to study COVID-19," he said. Already designed, that trial will measure the SARS-CoV-2 viral titers of participants as soon as they're enrolled, then look at how fast those titers decline compared to a control group. Establishing proof of concept for speeding clearance of the virus would pave the path to a phase III efficacy trial.
In addition to planning its own study, Covicept has also applied to make its molecule be part of the National Institute of Allergy and Infectious Diseases' ACTIV-2 trial, a study for outpatients with COVID-19.
What the mystery molecule is not, is an antiviral in the sense of the Gilead Sciences Inc. products Tamiflu (oseltamivir) or Veklury (remdesivir), each of which work directly on a virus. Instead, Covicept's molecule works on host cells that viruses infect, shutting down the machinery of those cells for making more copies of the virus, especially RNA viruses.
"In effect, it prevents the virus from replicating, allowing the immune system to deal with it in a much smaller viral load and, theoretically, at that level reducing a patient's chance of getting sick," he said. Such a mechanism might support both broad applicability, such as in other RNA viruses, and may also avoid the resistance risk antibody therapies now face in COVID-19.
Highlighting the drug's potential utility in COVID-19 is its tendency to accumulate in the lungs due to its chemical properties. The idea is that when a patient gets sick, they'll take the medicine as a pill, like with Tamiflu, causing viral replication to shut down over five to 10 days.
Forbion's investment in Covicept brings forward-thinking expertise in and support for the startup’s current work in manufacturing, formulation and trial work. It also points to the possible next directions for the company’s molecule, should it succeed. Sander van Deventer, an operating partner at Forbion, said RNA viruses such as SARS-CoV-2, SARS-CoV-1, MERS-CoV, Ebola, Dengue, Chikungunya and Zika are the most likely cause of future pandemics. "A small molecule like Covicept’s, that can be stockpiled to be immediately available and that could be used in multiple viruses, is of enormous benefit to global health,” he said.