-- Alopecia areata is the second autoimmune
indication being evaluated for bempikibart --
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230913908728/en/
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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