Covicept Therapeutics Launches Phase 2 Clinical Study

Covicept Therapeutic initiates a Phase 2 clinical study with PJS-539, an oral small molecule for the treatment of COVID-19 patients (SARS-CoV-2)

  • Covicept has initiated a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical trial in 150 patients in Brazil
  • Study will assess the safety and efficacy of PJS-539 in reducing viral load in patients with COVID-19
  • PJS-539 is a powerful, once-daily oral pill that inhibits the attachment, infection and replication of SARS-CoV-2 and other RNA viruses
  • Covicept is a California-based biotechnology company funded and operationally supported by Forbion, one of Europe’s leading life science venture capital firms.

San Diego, United States, October 6e, 2021 – Covicept Therapeutics, an antiviral drug development company, today announced that a double-blind, placebo-controlled Phase 2 trial of PSJ-539 has been launched and has begun recruiting patients with COVID-19 light to moderate. PSJ-539 has the potential to become the best-in-class small molecule for treating COVID-19 patients and also has the potential as a broad-spectrum antiviral drug targeting RNA viruses.

This multicenter, randomized, double-blind, placebo-controlled phase 2 clinical trial is designed to evaluate the safety and efficacy of PJS-539 in patients newly diagnosed with COVID-19. The trial on up to 150 patients is being conducted in Brazil, led by Bruno M Tomazini, MD of Hospital do Coração São Paulo. PSJ-539 is administered once daily for ten days and the primary endpoint of the study will be the effect of two different doses of PSJ-539 on viral load compared to placebo. Secondary endpoints include frequency of hospitalization and need for mechanical ventilation. The results are expected by the end of the year (1). The unique mechanism of action of PSJ-539 can prevent or minimize the development of resistance to vaccines and antiviral drugs.

Covicept has discovered several new host-dependent mechanisms by which PSJ-539 inhibits viral infections, highlighting its potential as a broad-spectrum antiviral drug targeting RNA viruses (2). Additionally, PSJ-539 has potent anti-inflammatory and anti-fibrotic effects in preclinical models of SARS-CoV-2-induced pneumonia. PSJ-539 has already been tested in human clinical trials, but its antiviral potential is new and Covicept holds an exclusive worldwide license on the new patents.

Large-scale GMP manufacture of the PSJ-539 has been established.

Professor Tsimikas, co-founder, CEO of Covivsept, commented: “It is an important step for this program to enter clinical development in less than a year since the creation of Covicept. Our team, with operational and financial support from Forbion, is providing the synergy needed to bring this drug to SARS-CoV-2 infected patients as quickly as possible. “

Sander van Deventer, Member of the board of directors of Covicept and Operating partner To Forbion, added: “Covicept is a great example of how academic researchers, entrepreneurs and investors can join forces and in a very agile way bring new treatment options to patients. PSJ-539 has the potential as a prophylactic and to treat early, moderate and severe illnesses to reduce viral load, minimize transmission and infection, as well as reduce long-term effects. We are very excited about the progress the team has made over the past nine months and continue to support the company on its journey to develop successful antiviral drugs. “

RNA viruses such as SARS-CoV-1 (“COVID”), SARS-CoV-2 (“SARS”), MERS-CoV (“MERS”), Dengue, Chikungunya, Zika and Ebola, are considered to be the most probable causes of devastating global pandemics. Vaccination strategies can prevent the spread of these viruses and protect individuals, but they take a long time to be implemented and demonstrated to be effective. Therefore, a small molecule that can be stored and used to inhibit viral replication would be an integral part of the response to pandemics caused by RNA viruses.

Details of the Covicept PSJ-539 program and results to date will be presented later today by Dr van Deventer at Sachs 8e Annual Health Technology Investment Forum in Basel, Switzerland as part of the Spotlight Showcase at 12:20 p.m. local time.

The references

  1. Clinicaltrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT05008393?term=covicept&draw=2&rank=1
  2. Cellular paper: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7489987/

About Covicept Therapeutics, Inc.

Covicept Therapeutics, Inc. was founded in 2020 in San Diego, California, USA, based on the findings of Professor Sam Tsimikas, Professor Philip Gordts, and Professor Jeffrey Eskowith. He is focused on the development of drugs to treat diseases caused by a variety of RNA viruses, including SARS-CoV-2. It is backed by $ 2.3 million in seed funding and operational support from Europe’s leading venture capital firm Forbion.

Covicept is developing PSJ-539, a small molecule that inhibits the attachment, infection and replication of SARS-CoV-2 and other RNA viruses. PSJ-539 has shown good tolerance and high potency with excellent and high biodistribution in tissues, including lungs, in humans, allowing relatively low daily doses. PSJ-539 also inhibits fibrosis, a property that can be valuable for patients infected with SARS-CoV-2, both short and long term. The unique mechanism of action of PSJ-539 can prevent or minimize the development of resistance to vaccines and antiviral drugs.

About Forbion

Forbion is a dedicated life sciences venture capital firm with offices in the Netherlands, Germany and Singapore. Forbion invests in life science companies active in the
(bio-) pharmaceutical space. Forbion manages well over 1.7 billion euros through several fund strategies that cover all stages of (bio-) pharmaceutical drug development. The current Forbion team consists of 20 life science investment professionals who have amassed impressive performance since the late 90s with successful investments in more than 70 companies. The firm is a signatory of the United Nations Principles for Responsible Investment. In addition to financial goals, Forbion selects investments that will have a positive impact on the health and well-being of patients. Its investors include the EIF, through its European Recovery Program (ERP), LfA, Dutch Venture Initiative (DVI), the AMUF and EFSI facilities and KfW Capital through the “ERP – Venture Capital Fund” program. investments ”. Forbion operates a joint venture with BGV, the seed and start-up fund manager, particularly focused on the Benelux and Germany. For more information, please visit: www.forbion.com

Contacts

Covicept Therapeutics, Inc.
Professor Tsimikas, co-founder, CEO
Phone. : +1 (0) 858 699 3528
Sander van Deventer, director of the board of directors of Covicept and operational partner of Forbion
Phone: +31 (0) 6 5498 2592

Forbion
Laura Asbjornsen, Head of Communications
E-mail: [email protected]
Phone: +31 (0) 35 699 30 00

Strategic communication of the Consilium
Ashley Tapp, Sue Charles, Kris Lam
E-mail: [email protected]
Phone: +44 (0) 20 3709 5700


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Margie D. Carlisle

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