MoonLake Immunotherapeutics to host a
Capital Markets Updateon Wednesday, September
11
ZUG, Switzerland, September 9,
2024 – MoonLake Immunotherapeutics AG (“MoonLake”; Nasdaq: MLTX), a
clinical-stage biotechnology company focused on creating next-level
therapies for inflammatory diseases, will host a Capital Markets
Update for investors and analysts live from New York on Wednesday,
September 11 from 2024, from 9:00 – 10:30 EST/06:00 – 08:30
PST/14:00 – 16:30 CETThe event will provide business
updates from MoonLake’s CEO Jorge Santos da Silva, CSO Kristian
Reich and CFO Matthias Bodenstedt and include details on the Phase
3 programs for our investigational Nanobody® sonelokimab (SLK) in
hidradenitis suppurativa (HS) and psoriatic arthritis (PsA).
In addition, MoonLake will provide pipeline
updates and details on additional catalysts for the 2024-2026
period, including for trials in new indications such as the Phase 2
trials of SLK in palmo-plantar pustulosis (PPP).
The Company will share views on the market
opportunities featuring insights from recent data analyses,
competitor performance and strategic imperatives for the Company. A
presentation on our financials will also be included.
A Q&A session involving all speakers will
follow the presentations.
Please register for the webcast online
here:https://edge.media-server.com/mmc/p/ncvrwcf8
Further details will be available on the Events
& Presentations section of the Company’s website.
-Ends-
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 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 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 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 is being assessed in two lead
indications, hidradenitis suppurativa (HS) and psoriatic arthritis
(PSA), and the Company is pursuing other indications in dermatology
and rheumatology.
For HS, sonelokimab is being assessed in two
Phase 3 trials, VELA-1 and VELA-2 following the successful outcome
of MoonLake’s end-of-Phase 2 interactions with the FDA and as well
as positive feedback from its interactions with the EMA announced
in February 2024. In October 2023, the full dataset from the Phase
2 MIRA trial at 24 weeks (NCT05322473) showed that maintenance
treatment with sonelokimab led to further improvements in
Hidradenitis Suppurativa ClinicalResponse (HiSCR)75 which is a
higher measure of clinical response versus the HiSCR50 measure used
in other clinical trials, setting a landmark milestone and other
clinically relevant outcomes. Prior to this, in June 2023, topline
results of the MIRA trial at 12 weeks showed that the trial met its
primary endpoint, HiSCR75.
For PsA, Phase 3 initiation is anticipated in Q4
2024 following the announcement in March 2024 of the full dataset
from the global Phase 2 ARGO trial evaluating the efficacy and
safety of the Nanobody® sonelokimab over 24 weeks in patients with
active PsA. Significant improvements were observed across all key
outcomes, including approximately 60% of patients treated with
sonelokimab achieving an ACR50 response at week 24. This followed
the positive top-line results in November 2023, where the trial met
its primary endpoint with a statistically significant greater
proportion of patients treated with either sonelokimab 60mg or
120mg (with induction) achieving an American College of
Rheumatology (ACR) 50 response compared to those on placebo at week
12. All key secondary endpoints in the trial were met for the 60mg
and 120mg doses with induction.
A Phase 2 trial is expected to be initiated in
palmo-plantar pustulosis (PPP), a debilitating disease affecting a
significant number of patients. In addition, a Phase 3 trial is
expected to initiate in adolescent HS, a disease that typically
begins at this early stage of a patient’s life, and also the period
in which irreversible damage and inflammatory remission is most
critical.
Sonelokimab will also be assessed for
seronegative spondyloarthritis with a Phase 2 trial in radiographic
and non-radiographic axial spondyloarthritis (axSpA) expected to
start in 2024. The trials will feature an innovative design
complementing traditional clinical outcomes with modern imaging
techniques.
Sonelokimab has also been assessed in a
randomized, placebo-controlled Phase 2b trial (NCT03384745) in 313
patients with moderate-to-severe plaque-type psoriasis. High
threshold clinical responses (Investigator’s Global Assessment
Score 0 or 1, and Psoriasis Area and Severity Index 90/100) were
observed 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).
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 their ability to be designed
into multivalent therapeutic molecules with bespoke target
combinations.
The terms Nanobody® and Nanobodies® are
trademarks of Ablynx, a Sanofi company.
CONTACT
MoonLake Immunotherapeutics
InvestorsCarla Bretes, Director IR & BDMatthias
Bodenstedt, CFOir@moonlaketx.com
MoonLake Immunotherapeutics
MediaPatricia Sousa, Director Corporate
Affairsmedia@moonlaketx.com
ICR Consilium Mary-Jane
Elliott, Ashley Tapp, Namrata TaakTel: +44 (0) 20 3709
5700MoonLake@consilium-comms.com
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