– ALLEGRO 2b/3 trial met primary efficacy
endpoint of improving scalp hair regrowth –
Pfizer Inc. (NYSE: PFE) today announced positive top-line
results from the Phase 2b/3 ALLEGRO trial evaluating oral
once-daily ritlecitinib in patients with alopecia areata, an
autoimmune disease driven by an immune attack on the hair follicles
that causes hair loss on the scalp and can also affect the face and
body.1,2 Ritlecitinib 50 mg and 30 mg achieved the primary efficacy
endpoint of the study, namely the proportion of patients with less
than or equal to 20 percent scalp hair loss after six months of
treatment versus placebo.
“We are pleased by these positive results for ritlecitinib in
patients with alopecia areata, a devastating and complex autoimmune
disease for which there are currently no U.S. Food and Drug
Administration (FDA) or European Medicines Agency approved
treatments,” said Michael Corbo, PhD, Chief Development Officer,
Inflammation & Immunology, Pfizer Global Product Development.
“We look forward to bringing this potential new treatment option to
patients living with alopecia areata as soon as possible.”
The Phase 2b/3 ALLEGRO trial met the primary efficacy endpoint
of improving scalp hair regrowth. All participants entered the
study with at least 50 percent scalp hair loss due to alopecia
areata, as measured by the Severity of Alopecia Tool (SALT) score.
A statistically significantly greater proportion of patients who
took ritlecitinib 30 mg or 50 mg once-daily, with or without a
four-week initial treatment of 200 mg once-daily, had 20 percent or
less scalp hair loss (an absolute SALT score ≤20) after 24 weeks of
treatment compared with placebo. This was followed by a 24-week
extension period, during which all participants initially
randomized to receive ritlecitinib continued on the same regimen,
while participants who received placebo during the initial 24 weeks
advanced to one of two regimens: 200 mg for four weeks followed by
50 mg for 20 weeks, or 50 mg for 24 weeks. The study also included
a 10 mg dosing arm, which was assessed for dose-ranging and was not
tested for statistically significant efficacy compared to
placebo.
The safety profile seen with ritlecitinib was consistent with
previous studies. Overall, the percentage of patients with adverse
events (AEs), serious AEs and discontinuing due to AEs was similar
across all treatment groups. The most common AEs seen in the study
were nasopharyngitis, headache and upper respiratory tract
infection. There were no major adverse cardiac events (MACE),
deaths or opportunistic infections in the trial. Eight patients who
were treated with ritlecitinib developed mild to moderate herpes
zoster (shingles). There was one case of pulmonary embolism in the
ritlecitinib 50 mg group, which was reported to have occurred on
Day 169. There were two malignancies (both breast cancers) reported
in the ritlecitinib 50 mg group, which were reported to have
occurred on Day 68 and Day 195. Both participants were discontinued
from the study.
Full results from this study will be submitted for future
scientific publication and presentation. These data, together with
data that will become available from ALLEGRO-LT, will form the
basis for planned future regulatory filings.
Ritlecitinib is the first in a new investigational class of
covalent kinase inhibitors that have high selectivity for Janus
kinase 3 (JAK3) and members of the tyrosine kinase expressed in
hepatocellular carcinoma (TEC) kinase family. In laboratory
studies, ritlecitinib has been shown to block the activity of
signaling molecules and immune cells believed to contribute to loss
of hair in people with alopecia areata.3
Ritlecitinib, which was granted Breakthrough Therapy designation
from the U.S. FDA for the treatment of alopecia areata in September
2018, is also being evaluated for vitiligo, rheumatoid arthritis,
Crohn’s disease and ulcerative colitis.
About the Phase 2b/3 ALLEGRO Trial
This randomized, placebo-controlled, double-blind study
investigated ritlecitinib in patients 12 years of age and older
with alopecia areata (n=718). Patients included in the study had 50
percent or more hair loss of the scalp, including patients with
alopecia totalis (complete scalp hair loss) and alopecia
universalis (complete scalp, face and body hair loss), and were
experiencing a current episode of alopecia areata that had lasted
between six months and ten years. Patients were randomized to
receive ritlecitinib 50 mg or 30 mg (with or without one month of
initial treatment with once-daily ritlecitinib 200 mg),
ritlecitinib 10 mg or placebo.
The primary endpoint was the proportion of patients with scalp
hair regrowth in response to ritlecitinib treatment, based on an
absolute SALT Score ≤20 at Week 24. SALT is a tool that measures
the amount of scalp hair loss. The tool divides the scalp into
standard regions, and each region contributes to the total SALT
score, which ranges from 0 to 100. A SALT score of 0 corresponds to
no scalp hair loss, while a SALT score of 100 corresponds to a
total lack of hair on the scalp.4
More information about the Phase 2b/3 ALLEGRO trial can be found
at https://www.clinicaltrials.gov under the identifier
NCT03732807.
About Alopecia Areata
Alopecia areata is an autoimmune disease characterized by patchy
hair loss, almost always involving the scalp, but sometimes also
involving the face (eyebrows, eyelashes, beard), the whole scalp or
the whole body.1,2 People suffering from alopecia areata experience
symptoms when immune cells attack healthy hair follicles, causing
the hair to fall out.1,2 The mean age of onset is between 25 and 35
years, but it can also impact older adults, children and
adolescents, and is seen in both sexes and all ethnicities.1,2
Alopecia areata is associated with poor health-related quality of
life for many patients, who may suffer from serious psychological
consequences, including depression and anxiety.1
About Pfizer Inflammation & Immunology
At Pfizer Inflammation & Immunology, we strive to deliver
breakthroughs that enable freedom from day-to-day suffering for
people living with autoimmune and chronic inflammatory diseases,
which can be debilitating, disfiguring and distressing,
dramatically affecting what they can do. With a focus on
Rheumatology, Gastroenterology and Medical Dermatology, our current
portfolio of approved medicines and investigational molecules spans
multiple action and delivery mechanisms, from topicals to small
molecules, biologics and biosimilars. Our differentiated R&D
approach resulted in one of the broadest pipelines in the industry,
where we purposefully match molecules to diseases where we believe
they can make the biggest difference. Building on our decades-long
commitment and pioneering science, we continue to advance the
standard of care for patients with these debilitating diseases and
are working hand-in-hand with patients, caregivers and the broader
healthcare community on healthcare solutions for the many
challenges of managing chronic inflammatory diseases, allowing
patients to live their best lives.
To learn more, visit
www.pfizer.com/science/immunology-inflammation.
Pfizer Disclosure Notice
The information contained in this release is as of August 4,
2021. Pfizer assumes no obligation to update forward-looking
statements contained in this release as the result of new
information or future events or developments.
This release contains forward-looking information about a
product candidate, ritlecitinib, including potential benefits, that
involves substantial risks and uncertainties that could cause
actual results to differ materially from those expressed or implied
by such statements. Risks and uncertainties include, among other
things, the uncertainties inherent in research and development,
including the ability to meet anticipated clinical endpoints,
commencement and/or completion dates for our clinical trials,
regulatory submission dates, regulatory approval dates and/or
launch dates, as well as the possibility of unfavorable new
clinical data and further analyses of existing clinical data; the
risk that clinical trial data are subject to differing
interpretations and assessments by regulatory authorities; whether
regulatory authorities will be satisfied with the design of and
results from our clinical studies; whether and when drug
applications may be filed in any jurisdictions for any potential
indication for ritlecitinib; whether and when any applications that
may be pending or filed for ritlecitinib may be approved by
regulatory authorities, which will depend on myriad factors,
including making a determination as to whether the product's
benefits outweigh its known risks and determination of the
product's efficacy and, if approved, whether ritlecitinib will be
commercially successful; decisions by regulatory authorities
impacting labeling, manufacturing processes, safety and/or other
matters that could affect the availability or commercial potential
of ritlecitinib; uncertainties regarding the regulatory or
commercial impact of or the results of clinical trials, including
A3921133, or any potential actions by regulatory authorities based
on analysis of such data; uncertainties regarding the impact of
COVID-19 on our business, operations, and financial results; and
competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2020 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
1 Villasante Fricke AC, Miteva M. Epidemiology and burden of
alopecia areata: a systematic review. Clinical, Cosmetic and
Investigational Dermatology. 2015;8:397-403.
doi:10.2147/CCID.S53985.
2 Pratt CH, King LE, Messenger AG, Christiano AM, Sundberg JP.
Alopecia areata. Nature reviews Disease primers. 2017;3:17011.
doi:10.1038/nrdp.2017.11.
3 King B, Guttman-Yassky E, Peeva E, Banerjee A, Sinclair R,
Pavel AB, Zhu L, Cox LA, Craiglow B, Chen L, Banfield C, Page K,
Zhang W, Vincent MS. A phase 2a randomized, placebo-controlled
study to evaluate the efficacy and safety of the oral Janus kinase
inhibitors ritlecitinib and brepocitinib in alopecia areata:
24-week results. J Am Acad Dermatol. 2021 Mar
20:S0190-9622(21)00601-0. doi: 10.1016/j.jaad.2021.03.050.
4 Olsen EA, Hordinsky MK, Price VH, et al. Alopecia areata
investigational assessment guidelines–part II. National Alopecia
Areata Foundation. J Am Acad Dermatol. 2004;51(3):440-447.
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