- Significant efficacy of CER-001 after a single intraocular
administration in a uveitis model with severe inflammation compared
with standard and best-in-class drugs
- Appointment of Mr Jérôme Martinez as Senior Advisor for
Ophthalmology
Regulatory News:
ABIONYX Pharma, (FR0012616852 - ABNX - PEA PME
eligible), a new generation biotech company dedicated to the
discovery and development of innovative therapies based on the
world's only recombinant human apoA-1, announces new positive
results in ophthalmology for the first class of CER-001-based
biomedicines for the treatment of ocular pathologies, and the
appointment of Mr. Jérôme Martinez as ABIONYX Pharma's Senior
Advisor in ophthalmology.
New positive long-term preclinical results evaluating the
efficacy of CER-001 after a single intraocular administration in a
uveitis model with severe inflammation
Following the beneficial clinical findings related to the
disappearance of visual blurring linked to corneal deposits in a
patient suffering from LCAT deficiency treated under a Temporary
Authorization for Use, and a marked improvement in the patient's
visual function (results published exclusively in the scientific
journal "Annals of Internal Medicine" in 2021), and still observed
after more than a year of follow-up, ABIONYX Pharma conducted new
preclinical studies in ophthalmology to qualify the efficacy
spectrum of recombinant apoA-I alone and in combination with a
corticosteroid, and to broaden its potential in new
indications.
After demonstrating the safety of CER-001, the recombinant
apoA-I was tested again to assess its action in reducing
inflammatory reactions and its tolerability after a single
intraocular administration (IVT) in a model of LPS-induced
uveitis.
Slit lamp examinations (cumulative
score)
74 animals participated in this study, divided into 8 groups.
Six hours after LPS injection, statistically significant reductions
in inflammation, measured by slit-lamp examination, were observed
for the groups treated with CER-001 alone or in combination with a
corticosteroid compared with the vehicle-treated group. CER-001
(cumulative score 3.1 ± 2.3, p= 0.0254) and best-in-class drug
(cumulative score 3.1 ± 1.5, p= 0.0228) were superior to vehicle.
No statistically significant differences were observed for the
other groups treated with standard therapies.
Twenty-four hours after induction, the significance observed at
six hours for the CER-001 and best-in-class drug-treated groups
versus the vehicle-treated group continued, demonstrating a
reduction in inflammation (cumulative score 3.9 ± 1.7 and 4.9 ±
1.2, respectively and p < 0.0001 and = 0.0018, respectively).
The downward trend observed at six hours compared with the
vehicle-treated group was confirmed by statistical significance for
CER-001 alone and CER-001 in combination (cumulative score 5.3 ±
1.3 and 4.6 ± 2.1, respectively and p = 0.0081 and = 0.0018,
respectively). No statistically significant differences were
observed for all other groups. Results for the CER-001 and CER-001
combination groups were comparable or better than those for the
best-in-class alone group.
Cell infiltration in aqueous
humor
Twenty-four hours after LPS injection, the highest level of
induced inflammation was reached in the vehicle-treated group, with
median values of 5920 cells/µL. A statistically significant
decrease in leukocyte infiltration was observed in the groups
treated with CER-001 alone and CER-001 in combination with a
corticosteroid, compared with the vehicle-treated group. For all
other groups, no significance was observed.
CER-001 alone or in combination with a corticosteroid, as tested
in this preclinical study, proved safe and well tolerated on the
ocular surface and inside the eye, when given by injection inside
the eye.
These new preclinical results reconfirm the major therapeutic
potential of the only recombinant apoA-I in ophthalmology. The
anti-inflammatory and/or reverse lipid transport-enhancing
properties of CER-001, and these new preclinical results in
uveitis, pave the way for clinical trials testing apoA-I in
patients with other severe inflammatory ocular diseases.
Appointment of Mr Jérôme Martinez as ABIONYX Pharma’s Senior
Advisor in ophthalmology
Jérôme Martinez has been appointed Senior Advisor to ABIONYX
Pharma for the development of CER-001 in ophthalmology. Jérôme has
over 30 years' experience in the management of pharmaceutical and
biotech companies in France and abroad. Before joining ABIONYX
Pharma, Jérôme Martinez was COO in France for the Japanese
pharmaceutical company SANTEN, specializing in ophthalmology and
rheumatology. From 2004 to 2011, he was Chairman of the Board of
Novagali Pharma, a laboratory specializing in ophthalmology, where
he oversaw Novagali Pharma's IPO and its sale to SANTEN in 2012.
With a background in pharmacology, Jérôme Martinez holds a Master
of Law in Health Administration from the Paris XI University, and
an MBA from HEC Paris / Keio University in Japan. He is also a
graduate of the JL Kellogg Graduate School of Management at
Northwestern University in Chicago and is certified in the
International Director Program at INSEAD.
Mr. Jérôme Martinez, ABIONYX Pharma's Senior Advisor in
ophthalmology, concludes: "After being profiled as a bioproduct
in ophthalmology, and tested in the reduction of inflammatory
reactions, recombinant apoA-I alone also proved to be effective in
a uveitis model with severe inflammation. More importantly, this
efficacy was compared with other market standards, notably the
best-in-class, and proved to be more than significant not only as a
stand-alone bioproduct, but also in combination with a
corticosteroid, after a single intraocular injection. This is very
promising for the development of the first class of biomedicines in
ophthalmology in the very broad field of severe indications
involving major vascular or lipid disorders such as AMD or
DME."
About uveitis
Acute anterior uveitis is a recurrent inflammatory disease of
the eye that occurs frequently and can have potentially blinding
sequelae. The pathogenesis of this disease is poorly understood.
Various circumstantial observations suggest that the innate immune
system plays a very important role in the development of
uveitis.
Patients suffering from acute anterior uveitis complain of
photophobia (sensitivity to light), often severe. Other symptoms
may include redness of the eye, tearing and decreased vision.
Characteristic examination findings include vessel congestion, the
presence of cells and proteins in the aqueous humor, and miosis. In
severe cases, hypopyon and/or fibrin may form.
Clinically, chronic progressive or recurrent forms of
non-infectious uveitis are treated with topical and/or systemic
corticosteroids.
However, long-term use of these drugs can lead to deleterious
ocular and systemic side effects such as glaucoma, cataracts,
osteoporosis, hypertension and diabetes. The use of alternative
steroid-sparing immunosuppressive agents has also shown clinical
benefits, but itself carries undesirable risks. Given these
limitations, there is a clear demand for the development of new
therapeutic strategies. Recent advances in our understanding of the
resolving mechanisms of inflammation, and the discovery of several
inflammatory mediators, have led to a whole new range of potential
therapeutic possibilities.
About ABIONYX Pharma
ABIONYX Pharma is a new generation biotech company that aims to
contribute to health through innovative therapies in indications
where there is no effective or existing treatment, even the rarest
ones. Thanks to its partners in research, medicine,
biopharmaceuticals and shareholding, the company innovates on a
daily basis to propose drugs for the treatment of renal and
ophthalmological diseases, or new apoA-I vectors used for targeted
drug delivery.
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version on businesswire.com: https://www.businesswire.com/news/home/20231120357018/en/
NewCap Investor relations Nicolas Fossiez Louis-Victor
Delouvrier abionyx@newcap.eu +33 (0)1 44 71 98 53
NewCap Media relations Arthur Rouillé abionyx@newcap.eu
+33 (0)1 44 71 00 15
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