MoonLake Immunotherapeutics
signs development and
manufacturing agreement with
Vetter Pharma International
GmbH
ZUG, Switzerland, July 26, 2022
– MoonLake Immunotherapeutics AG (MoonLake; Nasdaq: MLTX), a
clinical-stage biotechnology company focused on creating next-level
therapies for inflammatory diseases, today announced that it has
signed a Master Development Services Agreement with Vetter Pharma
International GmbH (Vetter), a leading global contract development
and manufacturing organization for fill and finish services,
ranging from development support, including clinical manufacturing,
through to commercial supply.
Under the agreement Vetter will be responsible
for the aseptic filling of syringes with sonelokimab, and the
subsequent assembly into an autoinjector combination device and
packaging. Sonelokimab is MoonLake’s investigational Nanobody®
designed to treat inflammatory disease by inhibiting the naturally
occurring IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive
inflammation. In addition, sonelokimab is designed to directly
target sites of inflammation and penetrate difficult-to-reach
inflamed tissues.
Development studies associated with the
manufacturing of sub-cutaneous sonelokimab for clinical trials and
commercial volumes have been concluded, and technical engineering
batches started in Q2 2022. The first clinical Good Manufacturing
Practice batches are expected to be manufactured in Q4 2022 as a
complementary, second supply point alongside the current source of
drug product for clinical use.
Oliver Daltrop, Chief
Technical Officer
of MoonLake, said, “I am excited
to work with such a high quality and reliable partner. With
Vetter’s world-class support, we have further strengthened the
supply chain for sonelokimab from drug filling through to finished
product.”
Carsten Press, Senior Vice
President Key Account Management, Supply Chain
Management and Marketing at Vetter,
added, “As an experienced service
provider for the production of vital medications for patients in
need, we look forward to partnering with MoonLake to bring its
novel Nanobody sonelokimab from the development stage to commercial
launch.”
- ends
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About MoonLake
Immunotherapeutics
MoonLake Immunotherapeutics is a clinical-stage
biopharmaceutical company unlocking the potential of sonelokimab, a
novel investigational Nanobody® for the treatment of inflammatory
disease, to revolutionize outcomes for patients. Sonelokimab
inhibits IL-17A and IL-17F by inhibiting the naturally occurring
IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation.
The company’s focus is on inflammatory diseases with a major unmet
need, including hidradenitis suppurativa and psoriatic arthritis,
conditions affecting millions of people worldwide with a large need
for improved treatment options. MoonLake was founded in 2021 and is
headquartered in Zug, Switzerland. Further information is available
at www.moonlaketx.com.
About
Nanobodies®
Nanobodies® represent a new generation of
antibody-derived targeted therapies. They consist of one or more
domains based on the small antigen-binding variable regions of
heavy-chain-only antibodies (VHH). Nanobodies® have a number of
potential advantages over traditional antibodies, including their
small size, enhanced tissue penetration, resistance to temperature
changes, ease of manufacturing, and the ability to design
multivalent therapeutic molecules with bespoke target
combinations.
The terms Nanobody® and Nanobodies® are
trademarks of Ablynx, a Sanofi company.
About Sonelokimab
Sonelokimab (M1095) is an investigational ~40
kDa humanized Nanobody® consisting of three VHH domains covalently
linked by flexible glycine-serine spacers. With two domains,
sonelokimab selectively binds with high affinity to IL-17A and
IL-17F, thereby inhibiting the naturally occurring IL-17A/A,
IL-17A/F, and IL-17F/F dimers. A third central domain binds to
human albumin, facilitating further enrichment of sonelokimab at
sites of inflammatory edema.
Sonelokimab has been assessed in a randomized,
placebo-controlled Phase 2b trial in 313 patients with
moderate-to-severe plaque-type psoriasis. Sonelokimab demonstrated
a rapid and durable clinical response (Investigator’s Global
Assessment Score 0 or 1, Psoriasis Area and Severity Index 90/100)
in patients with moderate-to-severe plaque-type psoriasis.
Sonelokimab was generally well tolerated, with a safety profile
similar to the active control, secukinumab (Papp KA, et al. Lancet.
2021; 397:1564-1575).
In an earlier Phase 1 trial in patients with
moderate-to-severe plaque-type psoriasis, sonelokimab has been
shown to decrease (to normal skin levels) the cutaneous gene
expression of pro-inflammatory cytokines and chemokines (Svecova D.
J Am Acad Dermatol. 2019;81:196–203). Sonelokimab is not yet
approved for use in any indication.
Cautionary Statement Regarding Forward
Looking Statements
This press release contains certain
“forward-looking statements” within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995. Forward-looking
statements include, but are not limited to, statements regarding
MoonLake’s expectations, hopes, beliefs, intentions or strategies
regarding the future including, without limitation, statements
regarding: plans for clinical trials and research and development
programs; and the anticipated timing of the results from those
trials; and the anticipated markets for products, if approved. In
addition, any statements that refer to projections, forecasts, or
other characterizations of future events or circumstances,
including any underlying assumptions, are forward-looking
statements. The words “anticipate,” “believe,” “continue,” “could,”
“estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,”
“potential,” “predict,” “project,” “should,” “would” and similar
expressions may identify forward-looking statements, but the
absence of these words does not mean that statement is not forward
looking.
Forward-looking statements are based on current
expectations and assumptions that, while considered reasonable by
MoonLake and its management, as the case may be, are inherently
uncertain. New risks and uncertainties may emerge from time to
time, and it is not possible to predict all risks and
uncertainties. Actual results could differ materially from those
anticipated in such forward-looking statements as a result of
various risks and uncertainties, which include, without limitation,
risks and uncertainties associated with MoonLake’s business in
general and limited operating history, difficulty enrolling
patients in clinical trials, and reliance on third parties to
conduct and support its clinical trials, and the other risks
described in or incorporated by reference into MoonLake’s Current
Report on Form 8-K filed on April 11, 2022 and subsequent filings
with the Securities and Exchange Commission.
Nothing in this press release should be regarded
as a representation by any person that the forward-looking
statements set forth herein will be achieved or that any of the
contemplated results of such forward-looking statements will be
achieved. You should not place undue reliance on forward-looking
statements in this press release, which speak only as of the date
they are made and are qualified in their entirety by reference to
the cautionary statements herein. MoonLake does not undertake or
accept any duty to release publicly any updates or revisions to any
forward-looking statements to reflect any change in its
expectations or in the events, conditions or circumstances on which
any such statement is based.
MoonLake
Immunotherapeutics InvestorsMatthias Bodenstedt,
CFOinfo@moonlaketx.com
MoonLake Immunotherapeutics
MediaMatthew Cole, Mary-Jane ElliottConsilium Strategic
CommunicationsTel: +44 (0) 20 3709
5700media@moonlaketx.comMoonLake@consilium-comms.com
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