-- Alopecia areata is the second autoimmune
indication being evaluated for bempikibart --
WALTHAM,
Mass. and DUBLIN,
Sept. 13,
2023 /PRNewswire/ -- Q32 Bio, a clinical stage
biotechnology company developing biologic therapeutics to restore
immune homeostasis, and Horizon Therapeutics plc (Nasdaq:
HZNP), today announced that the first patient has been dosed
in a randomized, double-blind, placebo-controlled, Phase 2
multicenter, proof-of-concept study to evaluate bempikibart in
adult patients with severe alopecia areata. Q32 Bio and Horizon are
collaborating to develop bempikibart, a fully human anti-IL-7Rα
antibody that re-regulates adaptive immune function by blocking
signaling mediated by both IL-7 and TSLP, two key immune
pathways.
"Dosing of the first patient in the Phase 2 study in alopecia
areata, in addition to our ongoing Phase 2 study in atopic
dermatitis, demonstrate the breadth of potential applications of
bempikibart and our deep commitment to transform the lives of
patients with autoimmune and inflammatory diseases," said
Jodie Morrison, board member and
acting chief executive officer, Q32 Bio. "Q32 Bio and Horizon are
mutually dedicated to advancing bempikibart expeditiously through
both Phase 2 studies."
"Alopecia areata is a complex disease with a significant unmet
medical need, where patients can experience patchy or total hair
loss that can impact their quality of life," said Elizabeth
H.Z. Thompson, Ph.D., executive vice president, research and
development, Horizon. "Bempikibart represents a potential
unique approach to correcting immune system dysregulation in this
and other diseases."
"IL-7 is involved in the pathogenesis of alopecia areata and
bempikibart has the potential to address this pathology by
inhibiting IL-7Rα function and modulating T-cell responses.
Bempikibart has the potential to provide long-term, durable
improvement in hair loss, including the potential for disease
remittance," added Jason Campagna,
M.D., Ph.D., chief medical officer, Q32 Bio. "We are pleased to
work alongside our partner, Horizon, to advance bempikibart to the
next stage of development for patients enduring the debilitating
physical and psychosocial effects of severe alopecia areata."
Alopecia areata is a common, acute onset, autoimmune disorder
that affects hair follicles and is characterized by transient,
non-scarring hair loss.1 It is the second most common
form of alopecia and is associated with comorbidities including
depression, anxiety and autoimmune diseases such as lupus
erythematosus and vitiligo.2 This condition may develop
at any age, disproportionately impacts women and African American
populations in the U.S. and the incidence of this disease is
estimated to be two percent of the population
worldwide.3-5
About Bempikibart
Bempikibart (formerly ADX-914) is a
fully human anti-IL-7Rα antibody that re-regulates adaptive immune
function by blocking signaling mediated by both IL-7 and TSLP. Q32
Bio has completed a biomarker-enabled Phase 1 study characterizing
the pharmacokinetics, pharmacodynamics and safety of bempikibart in
healthy volunteers. Q32 has initiated Phase 2 trials in atopic
dermatitis and alopecia areata.
About the Q32 Bio-Horizon Collaboration for
Bempikibart in Autoimmune Diseases
In August 2022, Q32 Bio and Horizon announced that
they had entered into a collaboration and option agreement to
develop bempikibart for the treatment of autoimmune diseases. Under
the terms of the agreement, Horizon is obligated to fund
development through completion of two Phase 2 trials of
bempikibart, with Q32 being operationally responsible for the
conduct of all program-related activities. Horizon received an
option to acquire the bempikibart program, exercisable through a
period following completion of the Phase 2 trials and related
development activities.
About Q32 Bio
Q32 Bio is a clinical stage
biotechnology company developing biologic therapeutics targeting
potent regulators of the innate and adaptive immune systems to
re-balance immunity in autoimmune and inflammatory diseases. Q32
Bio's lead programs, focused on the IL-7 / TSLP receptor pathways
and complement system, address immune dysregulation to help
patients take back control of their lives.
The Company's most advanced program, bempikibart, is a fully
human anti-IL-7Rα antibody that re-regulates adaptive immune
function and is being developed in collaboration with Horizon
Therapeutics for the treatment of autoimmune diseases, including
Phase 2 trials in both atopic dermatitis and alopecia areata. The
IL-7 and TSLP pathways have been genetically and biologically
implicated in driving several T cell-mediated pathological
processes in numerous autoimmune diseases.
Q32 Bio's lead program for innate immunity, ADX-097, is based on
a novel platform enabling tissue-targeted regulation of the
complement system without long-term systemic blockade – a key
differentiator versus current complement therapeutics. Q32 Bio has
recently completed a first-in-human, Phase 1, ascending dose
(SAD/MAD) clinical study of ADX-097 in healthy volunteers. For more
information, please visit www.Q32bio.com.
About Horizon
Horizon is a global biotechnology
company focused on the discovery, development and commercialization
of medicines that address critical needs for people impacted by
rare, autoimmune and severe inflammatory diseases. Our pipeline is
purposeful: We apply scientific expertise and courage to bring
clinically meaningful therapies to patients. We believe science and
compassion must work together to transform lives. For more
information on how we go to incredible lengths to impact lives,
visit www.horizontherapeutics.com and follow us
on Twitter, LinkedIn, Instagram and Facebook.
Forward-Looking Statements
This press release contains
forward-looking statements, including, but not limited to,
statements related to future clinical development of
bempikibart, activities and payments under the collaboration
between Horizon and Q32 and the potential benefits of bempikibart.
These forward-looking statements are based on Horizon's and Q32's
current expectations and inherently involve significant risks and
uncertainties. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which
include, without limitation, risks and uncertainties associated
with development, regulatory approval and commercialization of
novel therapeutic candidates, the timing of development activities
under the collaboration; the fact that the collaboration is subject
to early termination and the fact that Horizon has limited control
over the development of the bempikibart program prior to exercising
its acquisition option. For a further description of these and
other risks facing Horizon, please see the risk factors described
in Horizon's filings with the United States Securities and
Exchange Commission, including those factors discussed under the
caption "Risk Factors" in those filings. Forward-looking statements
speak only as of the date of this press release and Horizon
undertakes no obligation to update or revise these statements,
except as may be required by law.
References
- Trueb RM, Dias M. Alopecia Areata: A Comprehensive Review of
Pathogenesis and Management. Clin Rev Allergy Immunol.
2018;54(1):68-87.
- Chu SY, Chen YJ, Tseng WC, et al. Comorbidity profiles among
patients with alopecia areata: the importance of onset age, a
nationwide population-based study. J Am Acad Dermatol.
2011;65(5):949-956.
- Mostaghimi A, Gao W, Ray M, et al. Trends in Prevalence and
Incidence of Alopecia Areata, Alopecia Totalis, and Alopecia
Universalis Among Adults and Children in a US Employer-Sponsored
Insured Population. JAMA Dermatol. 2023;159(4):411–418.
- Lee H, Jung SJ, Patel AB, Thompson JM, Qureshi A, Cho E.
Racial characteristics of alopecia areata in the United States. J Am Acad Dermatol.
2020 Oct;83(4):1064-1070.
- Darwin, E., Hirt, P. A., Fertig, R., Doliner, B.,
Delcanto, G., & Jimenez, J. J. (2018). Alopecia Areata: Review
of Epidemiology, Clinical Features, Pathogenesis, and New Treatment
Options. International journal of trichology. 10(2),
51–60.
Q32 Bio Contacts:
Investors: Brendan Burns
Media: Sarah Sutton
Argot Partners
212.600.1902
Q32Bio@argotpartners.com
Horizon Therapeutics Contacts:
Investor Relations:
Tina
Ventura
Senior Vice President, Chief Investor Relations Officer
Investor-relations@horizontherapeutics.com
U.S. Media:
Geoff
Curtis
Executive Vice President, Corporate Affairs & Chief
Communication Officer
media@horizontherapeutics.com
Ireland Media:
Eimear
Rigby
media@horizontherapeutics.com
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SOURCE Q32 Bio