Selva Therapeutics, a preclinical biotechnology company dedicated to protecting global public health, announced today that the company has raised $3 million in a Series A financing round from private investors. The proceeds of the financing will be used to rapidly advance its investigational product, SLV213, into clinical trials as a leading oral drug candidate for the treatment of COVID-19, the disease caused by SARS-CoV-2 infection. In addition to COVID-19, SLV213 has the potential to be a treatment for multiple infectious diseases caused by other coronaviruses such as SARS, but also Ebola viruses and Nipah virus, as well as Chagas disease, a parasitic disease endemic to South and Central America and spreading into the southern United States. TrialSite was able to catch up with President and CEO Ted Daley.
Pandemic Rages & Urgent Need for New Therapies
The world has an urgent need for potent, effective, and safe treatments for COVID-19. In the United States, with only Remdesivir approved by the U.S. Food and Drug Administration (FDA), it has its place, but is limited to hospital scenarios involving an intravenous administration. Moreover, to date, it is proven only that the antiviral can reduce the time of illness by a few days. The National Institutes of Health (NIH) is placing Dexamethasone on the clinical guidelines but this is only for severe to critical cases when the patient also has the need for ventilation.
Although TrialSite continues to track a number of investigational and off-label approaches around the world, new entrants into the race for therapies, such as SLV213, are urgently needed to offer safe and effective treatments, to help ease the burden imposed by this pandemic. And that toll is high; as of this writing, over 3.93 million reported cases in the U.S., as well as 144.5 thousand deaths, make the country the epicenter of the pandemic and a prime market for orally administered, new, and effective treatment options.
Selva Therapeutics Background
Founded in 2017, the company’s intellectual property is based on research activities at the University of California, San Diego (UCSD), and is exclusively licensed to Selva Therapeutics. Foundation research established the broad and potent antiviral activity of SLV213 against a range of viruses by inhibiting host cell cysteine proteases. Selva’s CEO Daley informed the TrialSite that he has generated additional data that shows SLV213 is also highly potent against SARS-CoV-2 in vitro. Furthermore, the company has completed preclinical IND-enabling safety studies and a pre-IND meeting with the FDA to ready SLV213 for clinical development.
“Based on compelling preclinical safety profile and efficacy data, indicating high potency against SARS-CoV-2, we are focused on accelerating the clinical development of SLV213 as an oral treatment for COVID-19,” said Ted Daley, President and CEO, Selva Therapeutics. “The rapid development of SLV213 for COVID-19 can bring a valuable treatment to the market to meet the urgent need for COVID-19, as well as advance a pandemic preparedness drug with the potential to fight multiple life-threatening infectious diseases and protect global health.”
Novel Broad Spectrum Antiviral
Viruses work by infecting host cells and hijacking the cell’s replication machinery. A (spike) protein present on the viral envelope must bind to a receptor on the surface of the host cell and be activated in order to enter the cell. This activation is mediated by a host cysteine protease, cathepsin L. SLV213 is designed to block cathepsin L, thereby preventing the activation of the viral spike protein and blocking viral entry into host cells.
“Antivirals that specifically target the virus can be highly effective but can become ineffective if the virus mutates and cannot be used broadly to treat other viral infections,” said James McKerrow, Ph.D., M.D., Distinguished Professor and Dean, Skaggs School of Pharmacy and Pharmaceutical Sciences at University of California San Diego and scientific advisor, Selva Therapeutics. “Because SLV213 acts on the host cell to block viral entry, which is a conserved mechanism across many types of viruses, it has the potential to retain effectiveness against viral mutations and avoid resistance. It may also be a highly potent therapy against a number of viruses, either as a single oral agent or in combination with direct acting antivirals.”
While SLV213 can be dosed orally or intravenously, Selva is first advancing it as an oral drug candidate for COVID-19. There are many advantages to an oral therapeutic, including the ability to treat patients in an outpatient setting, a preferred treatment for mild to moderate and asymptomatic patients and for use as a prophylactic. As mentioned previously, such an approved treatment doesn’t exist yet in the United States; could SLV213 be the answer?
Use of Funds
“The Series A investment supports the rapid entry of SVL213 into the clinic for COVID-19 treatment in Q3 2020,” said Series A investor and Selva Board of Directors member, Kenneth Kelley. “With the potential for non-dilutive grant funding as well as additional equity capital, the company could accelerate the speed of clinical development to advance a much-needed new antiviral therapy in the fight against COVID-19.” Ted Daley informed TrialSite that if all goes according to plan, the company should be ready to proceed to Phase 1 clinical trial this year.
Call to Action: The TrialSite Network should keep an eye on Selva Therapeutics should they achieve forthcoming milestones of A) successful IND submission with the FDA, and B) execution of a Phase 1 trial that demonstrates safety and promising efficacy potential then the value of this venture gets richer.