Scinai Immunotherapeutics Announces Positive Regulatory
Feedback from the Paul Erlich Institute (the PEI) for its drug
development program towards Phase 1/2a clinical trial of its
anti-IL-17A/F nanoAb (SCN-1) in Plaque Psoriasis
- Clarified preclinical toxicology and clinical program for
Plaque Psoriasis First-in-human with intralesional injections for
the treatment of patients with mild to moderate Plaque
Psoriasis
- The PEI had requested to see data of efficacy in blocking
IL-17F; this data became available as per the Company's
announcement last week describing the positive in vivo proof of
concept results.
- The PEI accepted the Company's position that toxicology studies
can be conducted in pigs rather than in Non-Human Primates.
- The PEI accepted the Company's position to compare the SCN-1 to
placebo directly in patients with mild to moderate plaque psoriasis
while skipping the need for testing in healthy volunteers,
resulting in a phase 1/2a clinical trial, which will assess both
safety and efficacy in the same trial.
- The PEI agreed to compare SCN-1 to placebo on the same human
subject, a strategy that could significantly reduce the number of
patients required for the clinical trial
- The PEI commented that the manufacturing process looks well
developed and that controls and specifications presented are
acceptable
- The Phase 1/2a study is expected to include approximately 24
plaque psoriasis patients and is expected to commence in the second
half of 2025 with readout in 2026.
JERUSALEM, July 23,
2024 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) (the "Company"), a
biotechnology company focused on developing inflammation and
immunology (I&I) biological products and on providing CDMO
services through its Scinai Bioservices business unit, today
announced the receipt of minutes of meeting from a recent
Scientific Advice ("SA") with the Paul Erlich Institute, Federal
Institute for Vaccines and Biomedicines (the "PEI"), which is
considered acceptable guidance for IMPD filing with the European
Medicines Agency (EMA) and is also considered the European
comparable to a pre-IND meeting with the FDA in the U.S. The
Company believes that the minutes of meeting reflect positive
regulatory feedback, which can be translated into significant time
and cost savings in its IL-17 nanoAb drug development
plans.
![Scinai_Immunotherapeutics_Logo Scinai_Immunotherapeutics_Logo](https://mma.prnewswire.com/media/2310190/Scinai_Immunotherapeutics_Logo.jpg)
On June 4, 2024, Scinai's
scientific team met, over a video conference, with representatives
of the PEI for a pre-scheduled, official, Scientific Advisory
meeting during which Scinai presented its drug development plan of
its novel anti-IL-17A/F nanoAb for the treatment of mild to
moderate plaque psoriasis and asked the PEI for guidance and advice
on various aspects.
The Meeting
In the meeting, Scinai presented its Chemistry Manufacturing and
Controls package, its results from non-clinical ex-vivo and in-vivo
studies and its plans for toxicology and first-in-human clinical
trial. In addition, Scinai presented the advantages in developing
an anti-IL-17 nanoAb for local administration into the psoriatic
lesions and the unmet medical need for the intended indication of
patients with mild to moderate psoriasis. Scinai indicated that
localized treatments to date, including corticosteroid-based
creams/ointments and phototherapy require far more intense
treatment regimens. These treatments require either more frequent
applications (corticosteroids twice a day and biologics once a
month) or more frequent visits to the clinic (phototherapy). It is
expected that the biological activity of Scinai's nanoAb will last
well after the treatment which would potentially result in a far
less demanding treatment regimen. Moreover, as a considerable
proportion of patients with mild-moderate psoriasis do not respond
well to treatments that are intended for mild to moderate psoriasis
(corticosteroids, phototherapy) and are treated with biological
(mAbs), the unmet need appears well established.
Taken together, it was agreed by the PEI that the results of the
non-clinical Proof of Concept (PoC) study (results which were
announced on July 15th,
2024) and clinical explorations will shed further light on the
suitability of intended localized treatment setting and regimen for
Scinai's nanoAb.
Overall, the PEI commented that the manufacturing process looks
well developed, that the in-process controls and the Drug Substance
(DS) and Drug Product (DP) specifications are all acceptable. The
PEI accepted the Company's approach that for local treatment,
conducting toxicology studies in pigs rather than in Non-Human
Primates is acceptable. This would translate to a significant time
and cost saving for the Company. Additionally, the PEI was in
agreement with the proposed design for the clinical trial and its
definition as phase 1/2a trial, as it will evaluate both safety and
efficacy. They supported the recruitment of mild to moderate plaque
psoriasis patients (skipping the evaluation of the NanoAb in
healthy volunteers) and comparing the NanoAb to placebo. Again,
this will speed up the recruitment stage and lessen the cost. For
correct intra-patient comparison, the PEI recommended ensuring a
similar lesion size in the experimental and control groups.
Upon receiving the above guidance from the PEI, the Company
expects to commence preparations for a pre-clinical toxicology
study before commencing a first-in-human clinical trial of its
anti-IL 17 NanoAbs for the treatment of plaque psoriasis in
2025.
The unmet market need
Today, there are about 13 million patients diagnosed with plaque
psoriasis in the 7 major markets (US, EU5 and Japan). 50% of all psoriasis patients suffer
from mild disease and about 28% suffer from moderate
psoriasis1. Patients diagnosed with mild to moderate
plaque psoriasis often suffer from considerable and visible lesions
which may be uncomfortable, painful, and have a negative impact on
their social and mental well-being, especially when the lesions are
located on the face, genitals, scalp, palms of hands, and bottom of
feet. The therapeutics for mild to moderate plaque psoriasis
include mostly corticosteroids, applied topically, and
phototherapy. These treatments require very frequent use, have
risks for local adverse effects such as skin atrophy and
development of tolerance, and suffer from low patient adherence to
treatment schedule. The current therapeutics for moderate to severe
disease include mostly biologics and JAK inhibitors. While highly
efficacious, these treatments are administered systemically, are
highly expensive and require chronic use, which carries long term
health risks and considerable economic burden to the patients and
the health care system. Therefore, treatment of mild to moderate
plaque psoriasis is suboptimal and can be improved.
Scinai's product candidate is designed to address the major
shortcomings of currently available treatments. It is a biologic,
intended to be delivered locally, intradermally, into the
psoriatic lesions using a very short and almost painless needle.
Scinai's product is designed to allow patients with mild to
moderate psoriasis to benefit from a low frequency treatment that
comes with the high specificity and potency saved for biologics but
with significantly reduced risk of local side effects associated
with corticosteroids or systemic side effects associated with
systemic administration of biologics.
Dr. Tamar Ben-Yedidia, Scinai's
Chief Scientist, noted, "It is encouraging to receive such a
supportive regulatory summary for our plans. The PEI agreed with
the unmet need of the patients with mild-to-moderate psoriasis for
a better therapy and accepted our pre-clinical and clinical plans
that will allow faster development of this product."
"I'd like to thank the PEI for their collaboration and
guidance," continued Ben-Yedidia.
Scinai next intends to further fine tune dosing and drug
half-life and conduct a longer duration follow on in-vivo animal
study in late 2024, again, in collaboration with Prof. Gilhar of
the Technion Israel Institute of Technology, complemented by a
pre-clinical toxicology study before commencing a first-in-human
clinical trial in late 2025.
1 Global Data Plaque
Psoriasis: Global Drug Forecast and Market Analysis to 2030,
November 2021
About Scinai Immunotherapeutics
Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) is a
biopharmaceutical company with two complementary business units,
one focused on in-house development of inflammation and immunology
(I&I) biological therapeutic products beginning with an
innovative, de-risked pipeline of nanosized VHH antibodies
(NanoAbs) targeting diseases with large unmet medical needs, and
the other a boutique CDMO providing biological drug development,
analytical methods development, clinical cGMP manufacturing, and
pre-clinical and clinical trial design and execution services to
early stage biotech drug development programs.
Company Contacts
Investor Relations | +972 8 930 2529 | ir@scinai.com
Business Development | +972 8 930 2529 | bd@scinai.com
Website: www.scinai.com
Forward-Looking Statements
This press release contains forward-looking statements
within the meaning of the Private Litigation Reform Act of 1995.
Words such as "expect," "believe," "intend," "plan," "continue,"
"may," "will," "anticipate," and similar expressions are intended
to identify forward-looking statements. All statements, other than
statements of historical facts, are forward-looking statements.
Examples of such statements include, but are not limited to, the
timing of pre-clinical and clinical trials. These forward-looking
statements reflect management's current views with respect to
certain current and future events and are subject to various risks,
uncertainties and assumptions that could cause the results to
differ materially from those expected by the management of Scinai
Immunotherapeutics Ltd. Risks and uncertainties include, but are
not limited to, the risk that Scinai will not conduct a follow on
in-vivo animal study in late 2024, complemented by a pre-clinical
toxicology study, will not conduct an in-human clinical trial, or
that such studies and trial will be delayed; that; the risk of
delay in, Scinai's inability to conduct, or the unsuccessful
results of, its research and development activities, including the
contemplated in-vivo studies and a clinical trial; the risk that
Scinai will not be successful in expanding its CDMO business or
in-license other NanoAbs; the risk that Scinai may not be able to
secure additional capital on attractive terms, if at all; the risk
that the therapeutic and commercial potential of NanoAbs will not
be met or that Scinai will not be successful in bringing the
NanoAbs towards commercialization; the risk of a delay in the
preclinical and clinical trials data for NanoAbs, if any; the risk
that our business strategy may not be successful; the risk that the
European Investment Bank (EIB) may accelerate the financial
facility under its finance contract with Scinai; the risk that the
Company will not execute a definitive agreement with the EIB
providing for revised terms of the Finance Contract with EIB; the
risk that execution of such a definitive agreement will not resolve
the deficiency notice of Nasdaq with respect to the Company's
shareholders' equity; the risk that the Company will otherwise be
unable to regain compliance and remain compliant with the continued
listing requirements of Nasdaq irrespective of any such agreement
with the EIB; Scinai's ability to acquire rights to additional
product opportunities; Scinai's ability to enter into
collaborations on terms acceptable to Scinai or at all; timing of
receipt of regulatory approval of Scinai's manufacturing facility
in Jerusalem, if at all or when
required; the risk that the manufacturing facility will not be able
to be used for a wide variety of applications and other vaccine and
treatment technologies; and the risk that drug development involves
a lengthy and expensive process with uncertain outcomes. More
detailed information about the risks and uncertainties affecting
the Company is contained under the heading "Risk Factors" in the
Company's Annual Report on Form 20-F filed with the Securities and
Exchange Commission ("SEC") on May 15,
2024, and the Company's subsequent filings with the SEC.
Scinai undertakes no obligation to revise or update any
forward-looking statement for any reason.
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