- Very promising preclinical results of the apoA-I biovector
in an acute inflammation model
- Development of safe corticoids to limit traditional
corticoid-related side effects when used in AMD or DME
- Project to separate the ophthalmology activities and change
the name of IRIS Pharma Holding to APOGEYE Pharma
Regulatory News:
ABIONYX Pharma, (FR0012616852 - ABNX - PEA PME eligible)
(Paris:ABNX), a new generation biotech company dedicated to
the discovery and development of innovative therapies for patients,
today announced today announced its strategy in ophthalmology and
new positive preclinical results in two innovative technological
platforms: apotherapy and biovectorisation.
Cyrille TUPIN, Chief Executive Officer of ABIONYX Pharma, said:
"The acquisition of IRIS Pharma, one of the world leaders in
Contract Research in ophthalmology, a little over a year ago, has
borne fruit and has enabled us to structure a value-creating
strategy based on our flagship asset, the only natural recombinant
apoA-I lipoprotein in the world and one of the most advanced
biomedicines. Indeed, studies with IRIS Pharma have determined the
deployment of a strategy based on two technological platforms:
apotherapy that means an innovative therapy based on our natural
recombinant apoA-I alone, and biovectorization meaning
incorporation of various active ingredients into our proprietary
apoA-I complex used as a vector. The preclinical results of our
biovector in ophthalmology are very promising, especially for
corticoids, in order to optimise their efficacy while limiting
their side effects, which are one of the major concerns in
ophthalmology today worldwide."
Two innovative technological platforms: apotherapy and
biovectorization
ABIONYX Pharma is developing two innovative technological
platforms: apotherapy only based on the apoA-I and biovectorization
using apoA-I complexes as a vector to deliver several active
ingredients. These two platforms have multiple possible
applications in ophthalmology. ABIONYX Pharma has chosen to focus
its apotherapy approach initially on the ultra-rare LCAT disease,
known as Norum's disease, and on uveitis. ABIONYX Pharma's drug
candidates for LCAT and uveitis, CER-001 and ABNX-100,
respectively, are intended to be administered as systemic
intravenous injections to target patients with corneal opacity or
ocular inflammation in the setting of uveitis to achieve
significant functional visual improvement. ABIONYX Pharma's most
advanced drug candidate in ophthalmology, CER-001, targeting
Fish-Eye Diseas in LCAT Deficiency, is currently being used under
compassionate approval in Europe. As a reminder, CER-001 has been
granted Orphan Drug status in Europe by the EMA and in the United
States by the FDA. ABNX-100 in uveitis will enter the clinical
phase as soon as the company has received regulatory approval for
the advancement of sepsis, as its systemic treatment is very
similar to the targeted treatment in uveitis in apotherapy.
Uveitis is a disease characterized by inflammation of the tunica
vascularis of the eye called the uvea, which is relatively common
in industrialized countries with an estimated incidence of more
than 100 cases per 100,000 population in Europe and the United
States. Uveitis can cause reduced vision and, if not diagnosed
early and managed appropriately, ultimately lead to blindness.
Since ABIONYX's recombinant natural apoA-I complexes have been
shown to be effective in resolving systemic inflammation as
demonstrated in the Phase 2 RACERS study, in addition to offering a
reparative action on epithelial cells, it is a drug candidate of
choice for uveitis for which current treatments have limited
effects.
As far as biovectorization is concerned, uveitis can also be
treated, but two other major ophthalmology indications are
targeted, namely Age-related Macular Degeneration (AMD) and
Diabetic Macular Edema (DME) through two other drug candidates,
ABNX-1010 and ABNX-3010.
Very promising results of biovectorization
ABIONYX Pharma has been pursuing the development of new apoA-I
lipoprotein vectors for targeted drug delivery since 2018. Several
preclinical studies have already validated the concept, showing
that apoA-I complexes can be used as a specific drug delivery
platform targeting tumor cells or immune cells. Results from a
TARGET study validating this delivery method had been reported in
December 2018.
For ophthalmology, an apoA-I complex encapsulating a corticoid
was developed by ABIONYX Pharma and tested at IRIS Pharma. Many
active ingredients used in ophthalmology are hydrophobic, and the
main quality of the apoA-I complex, which contains lipids, is its
ability, thanks to its structure and size, to solubilize and
transport this type of active ingredient. Given the use of
corticoids in ophthalmology and their side effects (cortico-induced
cataract, glaucoma, etc.), the development of an apoA-I complex
carrying a corticoid appears to be of great value to increase the
benefits of treatment for patients, by enabling intraocular
injection. ABNX-3010 was therefore tested to validate a proof of
concept in a recognized and validated preclinical model of uveitis.
Groups treated with ABNX-3010 via the vitreous route showed
statistically a near-total reduction in the signs of uveitis, as
measured by protein concentration and cell infiltration in the
aqueous humor.
The safety profile of apoA-I complex encapsulating a corticoid,
as well as ABIONYX apoA-I complexes alone, allow for preclinical
and clinical development at the ocular surface and inside the eye,
targeting all corneal or retinal indications. These preclinical
results for the biovectorization of apoA-I validate a new
therapeutic approach based on lipid mechanisms in ocular
pathologies, and foreshadow a major therapeutic potential in
ophthalmology.
Phase 1/2 clinical trials for ABNX-1010 and ABNX-3010 could
begin during 2024, subject to regulatory approval. The biovector
technology platform for ophthalmology was developed with IRIS
Pharma's teams. This biovector platform, like the ophthalmology
apotherapy platform, is protected by new patents for 20 years.
The anti-inflammatory properties of apoA-I, observed in
ophthalmologic disease in different IRIS Pharma models, may
contribute to improved vision in patients suffering from uveitis,
and more generally in other indications with an inflammatory
component. apoA-I as structured phospholipid complexes allowing the
encapsulation of active ingredients, notably the most hydrophobic
ones such as corticoids, opens the field to new types of treatments
in ophthalmology and a new generation of biomedicines of which the
"safe corticoid" is the first candidate in ophthalmology.
Project to separate the ophthalmology activities and change
the name of IRIS Pharma Holding to APOGEYE Pharma
Given the strong development dynamics of the ophthalmology
activities, ABIONYX Pharma has decided to separate these specific
biotech activities, and plans to transfer its ophthalmology biotech
activities to IRIS Pharma Holding (IPH), with in particular the
implementation of a license agreement on biovectorization dedicated
to ophthalmology.
In order to identify the activities specific to this subsidiary,
IRIS Pharma Holding will be renamed APOGEYE Pharma, and thus more
clearly valorize apotherapy and biovectorization activities in
ophthalmology. The separation of the ophthalmic activities also
provides ABIONYX Pharma with strategic flexibility for future
partnerships.
New pipeline of ophthalmologic indications
Based on this new strategy, ABIONYX Pharma communicates a new
and more precise pipeline of indications.
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 HDL vectors used for targeted
drug delivery.
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version on businesswire.com: https://www.businesswire.com/news/home/20230331005391/en/
NewCap Investor relations Louis-Victor Delouvrier Nicolas
Fossiez abionyx@newcap.eu +33 (0)1 44 71 98 53
NewCap Media relations Arthur Rouillé abionyx@newcap.eu
+33 (0)1 44 71 94 98
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