RCS - Infex Therapeutics - Clinical candidate nominated for COV-X programme

PfizerAnnouncement

08/08/2023 08:15

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RNS Number : 5518I  Infex Therapeutics Holdings PLC  08 August 2023

 

Infex Therapeutics Holdings plc

("Infex" or the "Company")

 

Clinical candidate nominated for COV-X programme

COV-X is a novel first-in-class small molecule oral pan-coronavirus antiviral
candidate

 

·    COV-X outperforms Pfizer's approved antiviral in a pre-clinical mouse
SARS-CoV-2 efficacy trial

·    Unlike many competitors, COV-X blocks a unique key protein and has
potential for broad spectrum efficacy against new coronaviruses with pandemic
potential

·    Emerging resistance to M(PRO) inhibitors, such as Pfizer's antiviral,
is driving the urgent need for new therapeutic options to treat patients with
serious coronavirus infections

 

Alderley Park, Cheshire, U.K. Infex Therapeutics, a leading anti-infectives
specialist, announces the nomination of a clinical candidate for its in-house
developed COV-X programme. The candidate for COV-X, the Company's novel
first-in-class small molecule oral pan-coronavirus PL(PRO) inhibitor, was
selected following excellent in vivo efficacy data in a murine SARS-CoV-2
model that showed a near complete reduction in SARS-CoV-2 viral load in the
lungs and an outstanding safety profile when compared to Pfizer's approved
M(PRO) inhibitor nirmatrelvir.

 

The pre-clinical study aimed to assess the efficacy and safety profile of
COV-X against M(PRO) inhibitor nirmatrelvir and a control group (saline
vehicle only). Two dosing regimens were utilised; 100 mg/kg and 200 mg/kg.
Viral load was then measured by plaque assay and lung damage was monitored
using lung imaging. In five of the six samples dosed with COV-X at 200 mg/kg,
viral load in the lungs was below the limit of detection (Figure 1). Even at
doses five times lower than nirmatrelvir, COV-X provided protection from lung
damage (Figure 2), with treated groups showing a significant reduction in
inflammatory cytokines; IL-6 by 80% and CCL2 by 94%. COV-X also demonstrated a
superior DMPK profile to nirmatrelvir.

 

Unlike nirmatrelvir, COV-X targets the key coronavirus PL(PRO) enzyme.
PL(PRO ) is essential for viral replication and evasion of host immune
response, and is conserved across SARS-CoV-2, SARS-CoV-1, MERS and all related
coronavirus variants. As a result, COV-X has the potential for broad spectrum
efficacy against new coronaviruses or variants thereof with pandemic
potential.

 

Furthermore, development of new variants of SARS-CoV-2 that are resistant to
nirmatrelvir have been reported widely in recent weeks
(https://time.com/6301072/rising-covid-19-cases-booster-shot/) , with further
cross resistance to other drugs in the M(PRO) class. Infex's COV-X programme
offers an alternative for treatment of resistant strains, as a stand-alone
therapy, or in combination with M(PRO) drugs.

 

With a pre-clinical candidate nominated with back-up compounds, COV-X is
currently undergoing CTA/IND-enabling studies to provide a comprehensive
safety profile ahead of clinical stage development. Given the strong
pre-clinical data, Infex is accelerating its development towards partnerships
and commercialisation.

 

 

 

 

Dr Peter Jackson, CEO of Infex Therapeutics, commented: "With global
SARS-CoV-2 vaccines showing increasing weakness against new variants, it will
be essential to develop effective broad-spectrum antivirals that can
future-proof against new coronaviruses with pandemic potential. Following
encouraging pre-clinical data in comparison with Pfizer's M(PRO) inhibitor
nirmatrelvir, we have high hopes for our nominated candidate for our COV-X
programme. COV-X, our first-in-class small molecule oral pan-coronavirus
PL(PRO) inhibitor, demonstrated a superior efficacy and DMPK profile to
nirmatrelvir, Pfizer's approved blockbuster COVID prophylactic, and its
ability to reduce viral load in the lungs is key to minimising the chances of
long term viral conditions, such as long COVID. Given COV-X's outstanding
profile and potential value, we are now seeking a global pharmaceutical
partner to accelerate its development towards commercialisation."

 

 

For further information please contact:

 

 Infex Therapeutics Holdings plc              www.infextx.com (http://www.infextx.com)
 Dr Peter Jackson, CEO                        T: +44 (0)161 274 9440
 Carl Curran, Business Development Manager

 Walbrook PR Ltd (Media Relations for Infex)  infex@walbrookpr.com (mailto:infex@walbrookpr.com) or T: +44 (0)20 7933 8780
 Stephanie Cuthbert / Louis Ashe-Jepson       Mob: +44 (0)7796 794 663 / +44 (0)7747 515 393

 SP Angel Corporate Finance LLP (Financial Adviser to Infex)                           T: +44 (0)20 3470 0470
 Vadim Alexandre / David Hignell

 

About Infex (www.infextx.com (http://www.infextx.com) )

Infex Therapeutics Holdings plc is a leader in critical-priority infectious
diseases, with a broad and diverse pipeline of innovative best-in-class and
first-in-class drug candidates to address the urgent global shortage of novel
anti-infective treatments. The Company is building a differentiated pipeline
through in-house drug discovery, acquisition, co-development and in-licensing
of early stage/pre-clinical candidates, developing them to clinical proof of
concept before licensing to commercial pharma partners.

 

About COV-X programme

COV-X is a first-in-class small molecule oral pan-coronavirus therapy, which
targets a novel essential protease,  PL(PRO), conserved across SARS-CoV-2,
SARS-CoV-1, MERS and all related coronavirus variants and is different from
other novel protease targets currently in clinical development. The nominated
candidate for COV-X has demonstrated excellent pre-clinical data showing
superior DMPK and efficacy compared to M(PRO) inhibitor nirmatrelvir.

 

About nirmatrelvir

Nirmatrelvir, which was developed by Pfizer, is designed to block the activity
of M(PRO), an enzyme that the coronavirus needs to replicate. Nirmatrelvir is
designed to inhibit viral replication at a stage known as proteolysis, which
occurs before viral RNA replication. It is the active main protease inhibitor
utilised in Pfizer's antiviral pill PAXLOVID™, which is forecast to achieve
$30 billion in sales in 2023.

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