MC2 Therapeutics Receives Positive Feedback from FDA pre-IND
Meeting and Updates on Indication Expansion Strategy
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
13th, 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. 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
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, HSP90α and HSP90β 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
Media: ICR Consilium
Amber Fennell, +44 20 3709 5700,
MC2@consilium-comms.com