MC2 Therapeutics Receives Positive Feedback from FDA pre-IND Meeting and Updates
on Indication Expansion Strategy
* On track to file IND in mid-2025 for a Phase 2b clinical trial in
Hidradenitis Suppurativa ("HS") with MC2-32, a first-in-class, oral drug
candidate targeting pathways involved in numerous Immunology and
Inflammation indications ("I&I")
* Comprehensive pre-clinical studies show that MC2-32 is highly relevant for
neutrophilic dermatoses as well as other I&I diseases outside of the skin
(I&I pipeline in a product)
* MC2 Therapeutics expects to start a Phase 2 trial in rare disease Pyoderma
Gangrenosum in 2025
Copenhagen, May 13(th), 2024 - MC2 Therapeutics ("the Company"), a commercial
stage biotech company focused on developing novel treatment paradigms for
immunology and inflammatory diseases, today confirms it has received positive
feedback from a pre-Investigational New Drug ("IND") meeting with the US Food
and Drug Administration ("FDA") with respect to its first-in-class, oral drug
candidate MC2-32 for the treatment of Hidradenitis Suppurativa ("HS").
MC2-32 is a first-in-class, oral HSP90 inhibitor with a unique and highly
specific pharmacological profile that elicits a full spectrum effect of HSP90
inhibition, without the class side effects. Alongside its pro-inflammatory
action, MC2-32 has a specific targeted tissue distribution, supporting good
clinical response profile and tolerability, as demonstrated in a Phase 2a trial
published in JAMA Dermatology in December 2023
(https://jamanetwork.com/journals/jamadermatology/fullarticle/2812209). Based on
initial positive feedback from the FDA and subject to the completion of already
initiated pre-clinical studies, MC2 Therapeutics expects to file an IND for MC2-
32 in HS in mid-2025.
MC2-32's unique mode of action positions it well to address a multitude of other
neutrophilic dermatoses as well as other I&I diseases. Consequently, MC2
Therapeutics is planning to explore MC2-32 in a Phase 2 trial in Pyoderma
Gangrenosum ("PG"), a rare skin condition causing painful ulcers, for which
there is a significant unmet patient need and no approved treatments. It is
estimated that >50,000 people suffer from PG in the US and Europe alone,
representing a very large commercial opportunity.
The potential of MC2-32 will also be investigated in additional diseases in the
skin and other organs.
Jesper J. Lange, CEO of MC2 Therapeutics, commented: "Encouraging feedback from
the FDA marks an important milestone in the continued clinical development
progress of our oral drug candidate MC2-32 and is a testament to the high
quality of work by our team. Proceeding to the initiation of our Phase 2b trial
for HS will be the first step to exploit the full potential of MC2-32 in several
I&I indications where patients are currently left with no or limited treatment
options. We look forward to working closely with the FDA, our investigators and
stakeholders to advance the next phase of development."
Prof. Lars Iversen, CMO of MC2 Therapeutics, commented: "MC2-32's novel mode of
action, targeting multiple pro-inflammatory pathways and with specific tissue
targeting properties, highlights the potential to address a broader range of
neutrophilic dermatoses as well as other I&I diseases beyond the skin. We are
excited to explore this potential in PG, where no approved treatments exist, as
well as other I&I diseases."
MC2 Therapeutics also continues to progress the development of its MC2-25 iso-
cyanate scavenger for the treatment of Vulvar Lichen Sclerosus ("VLS"). The
Company's Phase 2a proof of concept trial for this indication remains on track,
with topline results expected in Q4.
About MC2 Therapeutics
MC2 Therapeutics is a commercial stage biotech company focused on developing
novel treatment paradigms for neutrophilic diseases.
Its pioneering approach in immunology is anchored in a deep understanding of
skin biology, clinical expertise and cross-silo thinking.
Its pipeline includes two first-in-class drug candidates both in Phase 2
clinical development, with novel modes of action and blockbuster potential in
multiple indications ("I&I pipeline in a product"):
* MC2-32: an oral HSP90 inhibitor with unique tissue specific targeting and a
new MOA that modulates multiple pro-inflammatory pathways and relevant
immune responses.
* MC2-25: an iso-cyanate scavenger addressing carbamylation of proteins and
amino acids in the skin by iso-cyanate, a dissociation product of urea.
For additional information on MC2 Therapeutics Group, please visit
www.mc2therapeutics.com (http://www.mc2therapeutics.com)
About MC2-32
MC2-32 (previously RGRN-305) is a new chemical entity small molecule, Heat Shock
Protein 90 (HSP90) inhibitor, with a proven capability to clinically attenuate
inflammation through a novel mode of action. MC2-32 modulates multiple
inflammatory pathways relevant for HS, while the exceptional pharmacological
properties of MC2-32 (specific tissue targeting) provide a remarkably favorable
safety profile. MC2-32 has been tested successfully in a Phase 2a2a double-
blinded, placebo-controlled, proof-of-concept trial in Hidradenitis Suppurativa
and a small clinical trial in Plaque Psoriasis.
HSP90 is a group of chaperone molecules involved in several cellular processes,
including cellular signaling and recent evidence has demonstrated that HSP90
inhibition has strong anti-inflammatory properties. MC2-32 selectively inhibits
the two HSP90 isoforms, HSP90? and HSP90? and causes inhibition of several pro-
inflammatory pathways involved in the pathogenesis of Hidradenitis Suppurativa.
MC2 Therapeutics acquired global (ex-greater China region) option rights to
exclusively license MC2-32 (formerly RGRN-305) for all human indications from
Regranion in September 2023.
About Hidradenitis Suppurativa (HS)
HS is an immune-mediated debilitating, life long, recurring, inflammatory skin
disorder with a high, unmet medical need. It is characterized by chronic,
painful nodules, abscesses, and suppurating sinus tracts that in the most severe
form cause significant scarring. Commonly affected body locations include the
armpits, below the breasts, the groin, the genitals, perineal and gluteal
regions.
The pathogenesis of HS is complex and implicates activation of cells of both the
innate and adaptive immune systems and involves several proinflammatory
pathways. Broad immune modulation can therefore be a preferred strategy.
About Pyoderma Gangrenosum (PG)
PG is one of a group of autoinflammatory disorders known as neutrophilic
dermatoses. It presents as a rapidly enlarging, recurrent and very painful
ulcer. The number of ulcers can vary from one to over a dozen and sometimes they
coalesce. The classic morphologic clinical presentation of PG in its fully
developed form is a deep ulcer with a purulent base and irregular, undermined
blue/purple borders which extends centrifugally.
PG is often associated with other inflammatory or hematologic diseases.
MC2 Therapeutics A/S
Lonni Goltermann, +45 2018 1111 or log@mc2therapeutics.com
(mailto:log@mc2therapeutics.com)
Media: ICR Consilium
Amber Fennell, +44 20 3709 5700, MC2@consilium-comms.com (mailto:MC2@consilium-
comms.com)
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