- Promising clinical results observed in the first 88 patients
evaluated so far, confirming the safety and an important clinical
benefit for patients
- Control of the infection at 3 months for 79% of 52 evaluated
patients having Prosthetic Joint Infections (PJI), either due to
Staphylococcus aureus or Pseudomonas aeruginosa
- Very consistent clinical data with recently disclosed
PhagoDAIR clinical results, reaching a consolidated infection
control rate at 3 months of 80% for 20 patients with PJI due to
Staphylococcus aureus
- Seven indications treated, with a majority of PJI cases and
several routes of administration tested
Regulatory News:
PHAXIAM Therapeutics (Euronext: PHXM - FR0011471135), a
biopharmaceutical company developing innovative treatments for
severe and resistant bacterial infections, today announces an
update on its clinical data from patients treated with the
Company’s phages under the compassionate status.
Since 2017, PHAXIAM has treated more than 120 patients under
Compassionate status, mostly suffering from hip or knee Prosthetic
Joint Infections (PJI). The vast majority was treated in France but
more and more compassionate patients are receiving PHAXIAM’s phage
therapy in other European countries.
Data from the first 88 patients evaluated so far show promising
results, consistent with previous evaluation, i.e. an infection
control at 3 months (clinical endpoint) reaching 75%. The latter is
considered as a high rate and represents a significant improvement
over the standard of care (SoC) in this “hard-to-treat” patient
population with severe relapsing infection, often associated with
antimicrobial resistance.
Among the patients evaluated, 52 suffered from PJI, either due
to Staphylococcus aureus (S. aureus PJI, n=40) or Pseudomonas
aeruginosa (P. aeruginosa PJI; n=12), with an overall control rate
of 79% at 3 months observed in this population. 77% control rate
was achieved in the S. aureus PJI sub-group and 83% control rate in
the P. aeruginosa PJI sub-group. At 12 months, the data are not
comprehensive so far, but the infection control rate is situated
between 64% and 67%, which remains very high for this
“hard-to-treat” population of patients with severe infections.
These clinical data are very consistent with those, recently
presented, and stemming from the PhagoDAIR pilot study, according
to which the consolidated infection control rate was 80% (16/20),
including patients for whom phages were administered during DAIR or
after a subsequent relapse leading to a rescue medication, with 1
or 3 administrations.
All these encouraging results confirm the relevance of launching
the GLORIA Phase II POC trial.
In addition to PJI, several other clinical indications were
targeted, such as osteomyelitis, vascular infections (including
endocarditis, cardiac implants and bacteremia) and lung infections
(including cystic fibrosis and ventilation-acquired pneumonia).
Different administration routes, including local, intravenous and
nebulisation were tested as well and were well tolerated.
More than half of the patients who were treated with PHAXIAM
phages were treated within the “PHAGEinLYON Clinic” program that is
supported by the “Fondation Hospices Civils de Lyon” set up at the
Lyon University Hospitals (HCL – Hospices Civils de Lyon).
Within the framework of the compassionate treatments, several
patients were treated under the AAC status (Autorisation d’Accès
Compassionnel – compassionate access program) obtained by the
Company in 2022 for its anti-S. aureus phages. Early 2025, PHAXIAM
is planning to file for another AAC to treat patients with
resistant P. aeruginosa infections. The objective is to expand as
soon as possible the eligible population to PHAXIAM’s phages under
a compassionate status.
Pascal Birman, MD, Chief Medical Officer of PHAXIAM,
stated: "The data we share today are consistent with those obtained
previously, and confirm the relevance of our clinical strategy
focused on high-value indications, such as PJI, for which patients
can take advantage of real clinical benefits. I would like to take
this opportunity to thank the HCL clinical team led by Pr. Ferry,
who performed more than half of the real-life compassionate
treatments. Leveraging on these robust results, together with the
clinical data from “PhagoDAIR” pilot study, we are more than ever
focused on the acceleration of our PJI clinical development,
through our lead global Phase II study (GLORIA).
Pr. Tristan Ferry, Coordinator of the Referral Center for the
Management of Complex Bone and Joint Infection (CRIOAC) at Hôpital
de la Croix-Rousse (HCL, Lyon), added: “These results show once
again that phage therapy is particularly relevant when it comes to
complex infections resistant to conventional treatments, such as
PJI. We are glad to receive the ability from the French health
ministry to centralize the requests at the national level, and to
be able to select during multidisciplinary meetings which patients
are the best candidate. We are treating a growing number of
patients under the compassionate status and look forward to
providing further clinical evidence to make phage therapy clearly
recognized as a reference treatment.”
About CRIOAC Lyon
The Centre de Référence des Infections Ostéo-articulaires
Complexes (CRIOAC - Reference Center for Complex Osteoarticular
Infections) provides the multi-disciplinary care required to offer
appropriate medical and surgical treatment, with a high level of
expertise and competence.
For more information, please visit
https://www.crioac-lyon.fr/en
About PHAXIAM Therapeutics
PHAXIAM is a biopharmaceutical company developing innovative
treatments for resistant bacterial infections, which are
responsible for many serious infections. The company is building on
an innovative approach based on the use of phages, natural
bacterial-killing viruses. PHAXIAM is developing a portfolio of
phages targeting 3 of the most resistant and dangerous bacteria,
which together account for more than two-thirds of resistant
hospital-acquired infections: Staphylococcus aureus, Escherichia
coli and Pseudomonas aeruginosa.
PHAXIAM is listed on the Euronext regulated market in Paris
(ISIN code: FR0011471135, ticker: PHXM). PHAXIAM is part of the CAC
Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All
Tradable, EnterNext PEA-PME 150 and Next Biotech indexes.
For more information, please visit www.phaxiam.com
Forward-looking information
This press release contains forward-looking statements,
forecasts and estimates with respect to the clinical programs,
development plans, business and regulatory strategy and anticipated
future performance of PHAXIAM and of the market in which it
operates. Certain of these statements, forecasts and estimates can
be recognized by the use of words such as, without limitation,
“believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”,
“estimates”, “may”, “will” and “continue” and similar expressions.
All statements contained in this press release other than
statements of historical facts are forward-looking statements. Such
statements, forecasts and estimates are based on various
assumptions and assessments of known and unknown risks,
uncertainties and other factors, which were deemed reasonable when
made but may or may not prove to be correct. Actual events are
difficult to predict and may depend upon factors that are beyond
PHAXIAM's control. Therefore, actual results may turn out to be
materially different from the anticipated future results,
performance or achievements expressed or implied by such
statements, forecasts and estimates. Investor should carefully read
the risk factors section of the Company which can be found in the
Company’s regulatory filings with the French Autorité des Marchés
Financiers (AMF), including in the Company’s 2023 Universal
Registration Document (Document d’Enregistrement Universel) filed
with the AMF on April 5, 2024 and future filings and reports by the
Company. Given these uncertainties, no representations are made as
to the accuracy or fairness of such forward-looking statements,
forecasts and estimates. Furthermore, forward-looking statements,
forecasts and estimates only speak as of the date of this press
release. PHAXIAM disclaims any obligation to update any such
forward-looking statement, forecast or estimates to reflect any
change in PHAXIAM’s expectations with regard thereto, or any change
in events, conditions or circumstances on which any such statement,
forecast or estimate is based, except to the extent required by
law.
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version on businesswire.com: https://www.businesswire.com/news/home/20250107151842/en/
PHAXIAM Thibaut du Fayet CEO +33 4 78 74 44 38
investors@phaxiam.com
NewCap Mathilde Bohin / Dušan Orešanský Investor
Relations Arthur Rouillé Media Relations +33 1 44 71 94 94
phaxiam@newcap.eu
PHAXIAM Therapeutics (EU:PHXM)
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