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

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

·         Covicept has initiated a Phase 2 multi-center, randomized, double-blind, placebo-controlled 150 patient clinical trial in Brazil

·         The study will evaluate safety and efficacy of PJS-539 in reducing viral load in patients with COVID-19

·         PJS-539 is a potent, once daily, oral pill that inhibits attachment, infection and replication of SARS-CoV-2 and other RNA viruses

·         Covicept is a California-based biotech company funded and operationally supported by Forbion, a leading European life sciences venture capital firm

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

This multi-center, randomized, double-blind, placebo-controlled Phase 2 clinical trial is designed to evaluate safety and efficacy of PJS-539 in patients recently diagnosed with COVID-19. The trial in up to 150 patients is being conducted in Brazil, led by Bruno M Tomazini, MD of the Hospital do Coração São Paulo . PSJ-539 is administered once a day over 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 the frequency of hospitalization and need for mechanical ventilation. Results are anticipated by the end of the year (1). The unique mechanism of action of PSJ-539 may prevent or minimize the development of resistance to vaccines and anti-viral medications.

Covicept has discovered several new host-dependent mechanisms by which PSJ-539 inhibits viral infections underscoring its potential as a broad-spectrum antiviral drug targeting RNA viruses (2). In addition, PSJ-539 has strong anti-inflammatory and anti-fibrotic effects in preclinical models of SARS-CoV-2-induced pneumonia. PSJ-539 has previously been tested in human clinical trials, however its anti-viral potential is novel and Covicept holds an exclusive world-wide license to the new patents.

Large scale GMP manufacturing of PSJ-539 has been established.

Professor Tsimikas, Co-Founder, Chairman and Chief Executive Officer of Covicept, commented: “It is a significant milestone for this program to move into clinical development in less than a year since Covicept was founded. Our team, together with Forbion’s operational and financial support, provides the necessary synergy to bring this medicine to patients infected with SARS-CoV-2 as quickly as possible.”

Sander van Deventer, Covicept Board member and  Operating Partner at 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 therapeutic options to patients. PSJ-539 has potential as a prophylactic and to treat early, moderate and severe disease to reduce viral load, to minimize transmission and infection, as well as to reduce the long-term effects. We are very  excited by the progress the team has made in the past nine months and continue to support the company on its way to develop potential blockbuster anti-viral 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 likely causes of devastating global pandemics. Vaccination strategies can prevent the spread of these viruses and protect individuals, but they require a significant lead time before implementation and demonstration of efficacy. Hence, a small molecule that can be stockpiled and used to inhibit viral replication would be an integral component 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 the Sachs 8^th Annual Healthtech Investment Forum in Basel, Switzerland in the Spotlight Showcase at 12.20pm local time.

References

1.     Clinicaltrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT05008393?term=covicept&draw=2&rank=1

2.     Cell 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 discoveries by Professor Sam Tsimikas, Professor Philip Gordts and Professor Jeffrey Eskowith. It 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 leading European VC firm Forbion.

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

About Forbion

Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands, Germany and Singapore. Forbion invests in life sciences companies that are active in the
(bio-) pharmaceutical space. Forbion manages well over EUR 1.7 billion across multiple fund strategies that cover all stages of (bio-) pharmaceutical drug development. Forbion’s current team consists of 20 life sciences investment professionals that have built an impressive performance track record since the late nineties with successful investments in over 70 companies. The firm is a signatory to the United Nations Principles for Responsible Investment. Besides financial objectives, Forbion selects investments that will positively affect the health and well-being of patients. Its investors include the EIF, through its European Recovery Programme (ERP), LfA, Dutch Venture Initiative (DVI), AMUF and EFSI facilities and KfW Capital through the Programme, “ERP – Venture Capital Fonds investments”. Forbion operates a joint venture with BGV, the manager of seed and early-stage funds, especially focused on Benelux and Germany. For more information, please visit: www.forbion.com

Contacts

Covicept Therapeutics, Inc.
Professor Tsimikas, Co-Founder, Chairman and Chief Executive Officer

Tel: +1 (0) 858 699 3528

Sander van Deventer, Covicept Board director and Forbion Operating Partner
Tel: +31 (0) 6 5498 2592