Full Press Release Details
Pharma's COVID-19 Oral and Intranasal/Pulmonary Protease Inhibitors Exhibit Powerful In Vitro Potency Against the SARS-CoV-2 Omicron
activity now confirmed against SARS-CoV-2 and all variants of concern
Omicron, Delta, Alpha, Beta and Gamma
Wash. (December 22, 2021) - Cocrystal Pharma, Inc. (Nasdaq: COCP) ("Cocrystal" or the "Company") announces
that in vitro studies demonstrate its oral and intranasal/pulmonary SARS-CoV-2 main protease inhibitors exhibit antiviral potency against
the Omicron variant. The Company earlier confirmed that its protease inhibitors demonstrated broad-spectrum antiviral activity against
SARS-CoV-2 and all major previously identified variants including Delta, Alpha, Beta and Gamma. Cocrystal expects to initiate Phase 1
clinical studies with its COVID-19 intranasal/pulmonary protease inhibitor CDI-45205 and an oral COVID-19 protease inhibitor as rapidly
confirm the antiviral activity of its protease inhibitors against SARS-CoV-2 Omicron variant, Cocrystal conducted an analysis of SARS-CoV-2
lineages covering all reported Omicron variant sequences including those from South Africa, Europe, Asia and North America, and identified
one prevalent mutation in the SARS-CoV-2 main protease. Using its proprietary platform technology and assays, the Company further confirmed
in vitro antiviral activity of its protease inhibitors against the Omicron variant.
ability to develop highly sensitive in vitro assays and X-ray crystals within a month is particularly important to evaluate the broad-spectrum
activity of our SARS-CoV-2 main protease inhibitors against a heavily mutated Omicron variant," said Sam Lee, Ph.D., Cocrystal's
President and interim co-CEO. "Our protease inhibitors bind to a highly conserved region of the active site of the protease that
is required for SARS-CoV-2 viral replication. We believe that, due to their novel mechanism of action, our protease inhibitors will be
effective against newly emerging SARS-CoV-2 variants. We are also highly encouraged by promising safety profiles of our SARS-CoV-2 oral
protease inhibitors from 7-day mouse oral dosing toxicity studies. Our goal is to rapidly advance two protease inhibitors into first-in-human
studies as rapidly as possible."
has been identified as a variant of concern by both the U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization
(WHO), and is spreading rapidly. Since being identified in the U.S. just three weeks ago, Omicron is now the dominant strain in the U.S.
according to the CDC," said James Martin, CFO and interim co-CEO. "Our protease inhibitors are being developed to show broad-spectrum
activity against SARS-CoV-2 infections regardless of the variant, with the added feature of high barriers to viral resistance."
is one of three COVID-19 programs underway at Cocrystal. In the second COVID-19 program, the Company plans to begin a Phase 1 study also
as rapidly as possible with an orally administered protease inhibitor. In the third COVID-19 program, Cocrystal is using its unique structure-based
technology platform to discover replication inhibitors for oral administration.
is among a group of protease inhibitors obtained by Cocrystal under an exclusive license agreement with Kansas State University Research
Foundation (KSURF) in 2020. CDI-45205 and several analogs showed potent in vitro activity against the SARS-CoV-2 Delta (India/B.1.617.2),
Gamma (Brazil/P.1), Alpha (United Kingdom/B.1.1.7) and Beta (South African/B.1.351) variants, surpassing the activity observed with the
original Wuhan strain. CDI-45205 has also shown good bioavailability in mouse and rat pharmacokinetic studies via intraperitoneal injection,
and no cytotoxicity against a variety of human cell lines. Preclinical research demonstrated a strong synergistic effect with the FDA-approved
COVID-19 medicine remdesivir. Additionally, a proof-of-concept animal study demonstrated that daily injection of CDI-45205 exhibited
favorable in vivo efficacy in mice infected with MERS-CoV-2.
Cocrystal Pharma, Inc.
Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication
process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based
technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal,
please visit www.cocrystalpharma.com.
Note Regarding Forward-Looking Statements
press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including
statements regarding our goals of initiating Phase 1 clinical studies as rapidly as possible, our attempts to discover replication inhibitors
for oral administration, and the potential efficacy of antiviral inhibitors against existing and new variants of COVID-19. The words
"believe," "may," "estimate," "continue," "anticipate," "intend,"
"should," "plan," "could," "target," "potential," "is likely,"
"will," "expect" and similar expressions, as they relate to us, are intended to identify forward-looking statements.
We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of
the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ
from those in the forward-looking statements include, but are not limited to, the risks arising from supply chain disruptions on our
ability to obtain products including raw materials and test animals as well as similar problems with our vendors and our current contract
research organizations (CROs) and future CROs and contract manufacturing organizations , the ability of our CROs to recruit volunteers
for, and to proceed with, clinical trials, the impact of the COVID-19 pandemic including new variants on the national and global economy,
the duration of presently discovered COVID-19 variants and our ability to treat new variants, the cooperation of the FDA in accelerating
development in our COVID-19 program, our collaboration partners' technology and software performing as expected, the results of
future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes,
and development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government.
Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year
ended December 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events
that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We
undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments
or otherwise, except as may be required by law.