- This non-comparative1 pilot study, including patients with
Prosthetic Joint Infections (PJI), recruited 29 patients, 26 of
whom were evaluable for clinical activity, out of the 64 initially
planned, due to overly restrictive inclusion criteria
- Clinical data obtained in the “Phages” experimental arm
(n=19), from patients who received a single intra-articular
injection: 1) confirm the safety of PHAXIAM’s
anti-Staphylococcus aureus (S. aureus) phages, 2) demonstrate an
infection control rate of 74% (14/19) and are very consistent with
data observed in compassionate treatments.
- Clinical data from 2 of the 4 relapsed patients (3 in the
“Phages” arm, 1 in the placebo arm) who benefited from rescue
medication, demonstrated infection control at 12 weeks, after
receiving 3 intra-articular injections of phages
- The overall rate of infection control, combining initial
treatment and patients having a rescue medication after relapse,
with 1 or 3 administrations injections, is still increased to
80% (16/20)
- PHAXIAM is now focusing on the GLORIA Phase II study, which
will enroll 100 patients in Europe and the United States from Q1
2025 onwards, using expanded criteria compared with PhagoDAIR, and
which aims to provide robust proof-of-concept of the clinical
benefit of its anti-S. aureus phages in PJI after 3 injections of
phages
Regulatory News:
PHAXIAM Therapeutics (Euronext: PHXM - FR0011471135), a
biopharmaceutical company developing innovative treatments for
severe and resistant bacterial infections, today announced the
clinical results of the PhagoDAIR I pilot study, demonstrating an
excellent phage safety profile and a 74% infection control rate in
the Phages arm for patients who received a single intra-articular
injection, consistent with clinical data that observed in patients
treated on a compassionate basis. Given the small number of
patients in the placebo arm, and the unbalanced randomization of
patients between the two arms, analysis of the study's primary
objective remains difficult to interpret, notably in the placebo
arm.
Encouraging Clinical results of PhagoDAIR I pilot study and
very consistent with generated compassionate clinical data
The PhagoDAIR study is a randomized, multicenter,
non-comparative, double-blind pilot study in patients with
S. aureus infection of hip or knee prostheses (PJI) occurring more
than one month after prosthesis insertion, with an indication for
suppressive antibiotic therapy. The study initially planned to
include 64 patients, but due to overly restrictive selection
criteria, only 29 patients were randomized, 26 of whom were
evaluable for clinical activity.
The randomization of the 29 patients was unbalanced, with 20
patients in the “Phages” arm and only 9 in the placebo arm.
Stratification by center and prosthesis location, combined with
small numbers and many clinical centers having recruited only one
or two patients, explain this imbalance, making it difficult to
analyze the study's primary objective in the placebo arm.
All patients were treated with the standard of care (DAIR -
debridement, antibiotic therapy and prosthesis maintenance), and
randomized between the experimental “Phages” arm, treated with
phage therapy (n=19) and the control arm receiving a placebo (n=7).
Phage-treated patients received anti-S. aureus phages active on
their strain (1 intra-articular injection), selected using
PHAXIAM’s phagogram. The primary endpoint was the percentage of
patients in each treatment arm free of infectious relapse at 12
weeks (infection control rate). This infection control analysis was
combined with a safety analysis, assessing adverse events, in each
of the two treatment arms.
Tolerance analysis of the 29 randomized patients confirmed the
safety of phages, which had already been noted at the biannual Data
Safety Monitoring Board (DSMB) meetings, which recommended
continuation of the study.
Of the 26 evaluable patients (19 in the “Phages” arm and 7 in
the placebo arm), 14/19 (74%) had a positive infection control rate
in the “Phages” arm and 5/7 (71%) in the placebo arm, in which the
antibiotics were administered alone. In the “Phages” arm, the
infection control rate at 12 weeks remains very consistent and
equivalent to that recently observed in patients treated with
phages under compassionate status, estimated at around 75% for a
population of around 60 patients. PHAXIAM also plans to publish
updated real-life data from around 90 European patients treated
with PHAXIAM phages under compassionate status.
Among the 7 relapsed patients, 4 patients (3 in the “Phages”
arm, 1 in the placebo arm) benefited from a rescue medication,
consisting of a weekly administration of phages for 3 consecutive
weeks. Among these 4 patients, 2 did not relapse within 3 months of
phage administration.
The consolidated infection control rate, including patients for
whom phages were administered during DAIR or after a subsequent
relapse leading to a rescue medication, with 1 or 3
administrations, was 80% (16/20). These encouraging results
validate the decision to follow the same treatment regimen in the
GLORIA Phase II study and confirm the relevance of launching this
clinical trial.
Focus on the GLORIA Phase II study, the 1st global phage
therapy study
The GLORIA study is PHAXIAM's most strategic and priority asset.
It is the first global, multicenter, randomized, placebo-controlled
proof-of-concept phage therapy study in PJI, conducted in Europe
and the United States. The study plans to include 100 patients with
PJI (hip or knee prosthesis) with an indication for open surgical
debridement (DAIR), regardless of the time lapse between prosthesis
placement and the onset of S. aureus infection; patients will be
treated with PHAXIAM anti-S. aureus phages with three
intra-articular injections or placebo, in combination with 12-week
curative antibiotic therapy, without suppressive antibiotic
therapy.
This clinical study will thus benefit from all the preparatory
work carried out in PhagoDAIR study, including in particular
knowledge of the clinical environment and clinical data, maximizing
the probability of success of the proof-of-concept demonstration
and better controlling patient inclusion, because: (1) the
exclusion/inclusion criteria are different, making it possible to
target a population circa six to seven times larger, including
patients from all DAIR indications and without prior suppressive
antibiotic therapy, unlike the PhagoDAIR study; (2) defined
statistical methodology makes it possible to limit the complexities
of randomization. The PhagoDAIR pilot study has thus enabled
PHAXIAM to prepare and structure the GLORIA comparative clinical
study, which will be launched in Q1 2025.
Regarding the protocol of this study, PHAXIAM has received IND
approval from the US FDA in Q4 2024; the Company has also submitted
the clinical protocol to the main European health authorities2,
including the MHRA in the United Kingdom. Subject to these
approvals, the GLORIA study will be conducted from Q1 2025 in 7
European countries (France, Germany, United Kingdom, Spain, Italy,
Netherlands, Sweden) and in the United States, making it the most
robust phage therapy study in the world.
Pascal Birman, PHAXIAM's Chief Medical Officer, stated:
“We are pleased that this study confirms the good tolerance of
intra-articular administration of phages, and that the rate of
infection control in the “Phages” arm is very consistent with all
the clinical data generated in real life, and that, combining
initial treatment and patients having a rescue medication after
relapse, the overall rate of infection control reaches 80%. We are
convinced that the GLORIA study, which has obtained FDA approval
and is currently being reviewed in Europe, will enable us to avoid
the difficulty of inclusion and the complexity of patient
randomization, by targeting a much larger population and using a
more appropriate statistical methodology. On the strength of these
valuable insights, we are now accelerating our clinical development
strategy in this indication, through our GLORIA Phase II study,
which should start enrollment in Q1 2025, as planned.”
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), adds: “The clinical data from
PhagoDAIR I are encouraging and validate the clinical interest of
phages and the methodological choices made for GLORIA, both from
the “Phages” arm, whose clinical activity (~75%) is very consistent
with real-life data from compassionate treatments, and from the 4
relapsed patients who received rescue medication, 2 of whom did not
relapse again within 3 months of phage administration.”
About PhagoDAIR study
The PhagoDAIR I study is a pilot, randomized, multicenter,
non-comparative, double-blind study in patients with hip or knee
prosthesis infection due to Staphylococcus aureus (SA), occurring
more than one month after prosthesis insertion. All patients were
treated with DAIR (debridement, antibiotic therapy and prosthesis
retention). Curative antibiotic therapy for 12 weeks is followed by
prolonged suppressive antibiotic therapy. Patients were randomized
to receive, in addition to intra-articular DAIR, either one or both
anti-Staphylococcus aureus phages, depending on the phagogram
result, or placebo.
The primary endpoint at 12 weeks was the percentage of patients
in each treatment arm free of infectious relapse. Infectious
relapse is defined by the presence of clinical signs of active
infection and/or the presence of Staphylococcus aureus in joint
fluid. Patients in infectious relapse, regardless of their
treatment arm, may receive a rescue medication consisting of weekly
intra-articular administration, under ultrasound control, of one or
both anti-Staphylococcus aureus phages, depending on the phagogram,
for 3 consecutive weeks.
This analysis of infection control at 3 months is combined with
a safety analysis (evaluation of adverse events, routine biology
and inflammatory markers) in each of the 2 treatment arms.
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
Forecast 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.
1 no statistical comparison per protocol.
2 A CTA (Clinical Trial Approval) application has been filed to
conduct the study in the 5 main European countries (France,
Germany, Italy, Spain and the UK), as well as in Sweden and the
Netherlands.
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version on businesswire.com: https://www.businesswire.com/news/home/20241230568703/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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