SAN DIEGO–(BUSINESS WIRE)–Selva Therapeutics, Inc. today announced that the Phase 1 clinical study met its primary objective of demonstrating safety and tolerability of SLV213, a potential oral treatment for COVID-19. The company plans to rapidly advance SLV213 into a Phase 2 study in non-hospitalized COVID-19 patients. SLV213 is a small molecule drug candidate that inhibits cathepsin L, a human cysteine protease found in lung and other cells, to block viral entry. SLV213 has been shown to have broad antiviral activity against coronaviruses (including SARS-CoV-2), Ebola viruses, and paramyxoviruses. Because SLV213 inhibits a host protein to block viral entry, it has the potential to retain effectiveness and avoid resistance against viral mutations and could be a highly potent therapy against a number of viruses, either as a single oral agent or in combination with direct acting antivirals.
The Phase 1 study was a randomized, placebo-controlled, double-blinded study conducted in healthy volunteers. No dose limiting toxicity was reported in all dose groups tested, suggesting that SLV213 is safe for further clinical development. Pharmacokinetic profiles indicate a dose-dependent increase in SLV213 plasma levels and compatibility with twice daily dosing.
“We successfully completed our Phase 1 study with no dose-limiting toxicity,” said Ken Krantz M.D., Ph.D., Chief Medical Officer of Selva Therapeutics. “This positive outcome, which is further supported by our in vitro and in vivo data that demonstrate the activity of SLV213 as a potent antiviral therapeutic, allows Selva to move forward with testing SLV213 in a Phase 2 study in early COVID-19 patients.”
In addition to demonstrating the safety of SLV213, Phase 1 data also demonstrate that SLV213, when administered orally, achieves plasma levels expected to be efficacious based on primate studies. In preclinical studies in nonhuman primates (NHPs) in both prophylactic and therapeutic settings, SLV213 was shown to protect against lung damage infected with SARS-CoV-2, compared to untreated controls. Lung weights of NHPs treated with SLV213 remained normal in both settings at approximately 0.5% of total body weight, whereas the lung weights of control animals increased up to two-fold. The increased lung weights indicate severe inflammation and edema, which was confirmed by histopathological analyses.
“As an oral small molecule drug with broad antiviral activity, SLV213 could be a valuable treatment that retains activity against SARS-CoV-2 mutations and can be easily administered in any setting,” said Felix Frueh, Ph.D., Selva’s Chief Scientific Officer. “Furthermore, additional preclinical data suggest SLV213 could be used as a prophylactic treatment.”
Selva’s CEO, Ted Daley added, “Completing Phase 1 is an important milestone for our program, and we’re excited to proceed into patient trials.”
SLV213 is a novel, orally available, small molecule antiviral drug candidate that inhibits human host cell cysteine proteases to block viral entry. 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. In addition, SLV213 potentially has broad antiviral activity against coronaviruses, Ebola viruses, and paramyxoviruses, including Nipah virus. It also has completed preclinical development as a potential therapy against Chagas disease, a parasitic disease endemic to South and Central America and spreading into the southern United States. SLV213 was developed based on research from UC San Diego and the university exclusively licensed it to Selva Therapeutics.
About Selva Therapeutics
Selva Therapeutics is a privately held biotechnology company dedicated to the development of therapeutics for infectious diseases. By rapidly developing SLV213 for COVID-19, Selva Therapeutics intends to bring a valuable treatment to the market that has the potential to fight multiple life-threatening infectious diseases. For more information, visit www.selvarx.com.
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