SAN FRANCISCO - Thursday, 28. May 2026
RLS-1496
is an investigational, first-in-class, disease-modifying, selective
glutathione peroxidase 4 (GPX4) modulator that targets pathologic
senescent and other stressed, aging cells that drive chronic,
age-dependent diseases, such as AK, and represents a novel drug category
— Adaptive SenoTherapeutics
In recognition of May as Skin Cancer
Awareness Month, Rubedo is calling attention to the myths and facts
surrounding AKs — and to the urgent need for a new generation of
treatments that are effective without the side-effect burden of today's
options
(BUSINESS WIRE)--Rubedo Life Sciences, Inc.
(Rubedo), an AI-driven, clinical-stage biotech focused on selective
cellular rejuvenation medicines targeting aging cells, today announced
preliminary results from a Phase 1b/2a study of RLS-1496 in patients
with actinic keratosis (AK), a common age-related condition resulting in
precancerous skin lesions, that is most commonly seen after age 65.1
The open-label multi-center trial, conducted in the United States,
assessed the safety, tolerability, and clinical effects of RLS-1496 1%
cream in adult patients with AK on the forearms. RLS-1496 is the first
selective glutathione peroxidase 4 (GPX4) modulator to be studied in
human trials, and the first targeting cellular rejuvenation as a new
therapeutic pathway in a novel category called Adaptive
SenoTherapeutics. Interim data from the study were presented at the RBC
Capital Markets Global Healthcare Conference in New York City on May 19,
2026.
Preliminary RLS-1496 Actinic Keratosis Trial Results
The
Phase 1b/2a study of RLS-1496 showed a 46% reduction in AK count
compared to 11% for untreated control at 4 weeks in the first 18 of 24
patients evaluated
RLS-1496 was associated with favorable safety,
with no serious adverse events (AEs) and no discontinuations due to AEs
during the 4-week study
RLS-1496 was well-tolerated, causing minimal local irritation, an area of high unmet need in the standard of care
A Phase 2b dose-ranging AK study for RLS-1496 will begin in Q4
“A
46% reduction in AK lesions at four weeks, achieved with minimal
irritation, is exciting since so many patients are hesitant to use
current treatments due to redness, peeling, pain, and weeks-long
recovery,” said Rubedo CEO Frederick Beddingfield, III, MD, PhD, FAAD,
who is also a practicing dermatologist. “AKs are precancerous lesions
that lead to squamous cell carcinoma, and patients deserve a therapy
that is designed to be both effective and tolerable. We look forward to
advancing RLS-1496 for AKs, as well as continuing its development in
psoriasis, atopic dermatitis, photo-aging, and other degenerative
diseases and conditions associated with the aging process.”
These
AK data results follow the preliminary results from Rubedo’s recently
completed Phase 1b clinical trial, conducted in the European Union,
which assessed the safety, tolerability, clinical effects, plasma
bioavailability, and pharmacodynamics of topical RLS-1496. This
single-center, ascending-dose, randomized, double-blind,
vehicle-controlled trial in patients with plaque psoriasis, atopic
dermatitis, and skin aging (photo-aged skin) met its primary safety
endpoint, with RLS-1496 also demonstrating early signs of efficacy,
including a remarkable 20% decrease in epidermal thickness in psoriasis
patients on therapy compared to a 30% increase with patients on
vehicle.2
“The preliminary results from this AK trial, coupled
with those from our Phase 1 trial in patients with plaque psoriasis,
atopic dermatitis, and skin aging, show continued promise for RLS-1496
as the first GPX4 modulator and a new class of Adaptive
SenoTherapeutics,” said Rubedo Chief Scientific Officer and Founder
Marco Quarta, PhD. “By clearing damaged senescent cells and restoring
the health of stressed but viable cells, we aim to address biological
aging at its cellular root, with implications that extend well beyond
dermatology to fibrosis, metabolic disease, sarcopenia, and
neurodegeneration. What makes RLS-1496 particularly exciting is that it
appears to act across several fundamental hallmarks of aging — from
cellular senescence to autophagy and oxidative stress imbalance. This is
the kind of multi-axis biology we believe will define the next
generation of true longevity medicines.”
The data from Rubedo’s
RLS-1496 AK trial, as well as data from the Phase 1b trial, including a
comprehensive data set of 70 subjects assessing RLS-1496 in aging skin,
are being compiled for submission to major medical journals and medical
meetings.
Actinic Keratosis: A Common Health Condition with an Unmet Need
It
is estimated that 58 million Americans have one or more AKs.3 The U.S.
annual market size for AKs was $3.55 billion in 2025, and will grow to
$4.8 billion by 2035.4 In recognition of Skin Cancer Awareness Month,
Rubedo is calling attention to common myths that are believed about AKs
and highlighting why new treatments are still urgently needed for the
millions of people affected by AKs.
Myth 1: AKs are harmless sun spots and usually go away on their own.
The Facts:
AKs
form as a result of long-term sun exposure, and often appear as small,
rough patches of skin that can vary in color. They typically are found
on sun-exposed areas of the body, including the face, scalp, neck, arms,
and hands.3
Left untreated, AKs can progress into squamous cell
carcinoma (SCC), which is the second most common skin cancer.5 An
estimated 1.8 million cases of SCC are diagnosed each year,6 and it is
estimated that 82% of SCCs begin as AKs.5
Myth 2: AKs are rare.
The Facts:
AKs
are among the most common diagnoses made by dermatologists, with a
global prevalence of approximately 14%.7 The prevalence of AK increases
with age, frequently developing after age 50 but most commonly seen
after age 65.1
While a single lesion carries a relatively low risk of
progression, the presence of one AK indicates a higher likelihood of
developing additional lesions over time, increasing the cumulative risk
of skin cancer.3
Myth 3: Current AK treatments are good enough.
The Facts:
Available
treatments — including topical creams, cryosurgery, and photodynamic
therapy — can be effective but are often associated with pain, redness,
swelling, crusting, or peeling that can take weeks to heal.8
These
side effects lead some patients to delay or discontinue treatment,
leaving lesions untreated and increasing the risk that AKs progress to
skin cancer.8 New effective treatment approaches with improved
tolerability are needed to protect patients from preventable cancer.
About RLS-1496 and GPX4 Modulation
Rubedo’s
lead candidate RLS-1496, being developed for topical and oral
administration, is a first-in-class, disease-modifying GPX4 modulator
selectively targeting pathologic senescent and other stressed, aging
cells that drive chronic, age-dependent diseases. These include
immunology and inflammation (I&I), dermatology and skin aging,
metabolic syndrome (obesity, diabetes, liver fibrosis), sarcopenia, and
neurodegenerative disease.
In certain pathologic cells, aging is
associated with an imbalance in GPX4. Modulation of GPX4 sensitizes
cells to ferroptosis, which is a type of programmed cell death and is
believed to be an Achilles heel of senescent cells. By modulating GPX4
in ferroptosis-sensitive senescent “aged” cells, RLS-1496 may be able to
clear these cells to fight disease and also support healthy cells to
function properly and restore tissue homeostasis. Beyond its targeted
senolytic function in triggering selective ferroptosis within
pathological senescent cells, RLS-1496 could also act as a restorative
modulator that induces a vital 'redox-reset' through a controlled
hormetic response in stressed neighboring cells, effectively clearing
the source of chronic inflammation while actively re-establishing
healthy tissue homeostasis. This dual-action mechanism represents a
novel drug category—Adaptive SenoTherapeutics.
RLS-1496 uses
Rubedo’s proprietary, AI-driven drug discovery platform ALEMBIC™, which
identifies targets within pathologic senescent cells and develops
selective cellular rejuvenation medicines for these targets.
About Rubedo Life Sciences
Rubedo
Life Sciences is a clinical-stage biotech developing a broad portfolio
of innovative selective cellular rejuvenation medicines targeting aging
cells that drive chronic age-related diseases. Our proprietary AI-driven
ALEMBIC™ drug discovery platform is developing novel first-in-class
small molecules to selectively target pathologic and senescent cells,
which play a key role in the progression of pulmonary, dermatological,
oncological, neurodegenerative, fibrotic, and other chronic disorders.
Our lead drug candidate – RLS-1496, a potential first-in-class
disease-modifying GPX4 modulator – is currently in Phase I clinical
trials. The Rubedo leadership team is composed of industry leaders and
early pioneers in chemistry, AI technology, longevity science, and life
sciences, with expertise in drug development and commercialization from
both large pharmaceutical and leading biotechnology companies. The
company is headquartered in Mountain View, CA, USA, and has offices in
Milan, Italy. For additional information, visit www.rubedolife.com.
1
Flohil SC, van der Leest RJT, Dowlatshahi EA, et al. Prevalence of
Actinic Keratosis and Its Risk Factors in the General Population: The
Rotterdam Study. Journal of Investigative Dermatology, Volume 133, Issue
8, 2013, Pages 1971-1978, https://doi.org/10.1038/jid.2013.134
2
Vitari A, Laslavic A, Spellman M, et al. Abstract 0510: Clinical study
of RLS-1496 topical cream: Targeting cellular senescence in patients
with mild-to-moderate plaque psoriasis. Presented at 2026 Annual Meeting
of the Society for Investigative Dermatology (SID).
https://www.sidnet.org/wp-content/uploads/2026/05/SID_Chcago26_Abstract_FInal_4.pdf#page=132
3
The Skin Cancer Foundation. Actinic Keratosis Overview. Accessed May
2026.
https://www.skincancer.org/skin-cancer-information/actinic-keratosis/
4
Nova1Advisor. U.S. Actinic Keratosis Treatment Market Size, Share &
Trends Analysis Report By Therapy (Topical/Drugs, Surgery, Photodynamic
Therapy), By Drug Class, By Product, By End-use, And Segment) -
Industry Analysis, Share, Growth, Regional Outlook and Forecasts,
2026-2035. Accessed May 2026.
https://www.novaoneadvisor.com/report/us-actinic-keratosis-treatment-market
5
Li Z, Lu F, Zhou F, et al. (2025). From actinic keratosis to cutaneous
squamous cell carcinoma: the key pathogenesis and treatments. Frontiers
in immunology, 16, 1518633. https://doi.org/10.3389/fimmu.2025.1518633
6
The Skin Cancer Foundation. Squamous Cell Carcinoma Overview. Accessed
May 2026.
https://www.skincancer.org/skin-cancer-information/squamous-cell-carcinoma/
7
George CD, Lee T, Hollestein LM, et al. Global epidemiology of actinic
keratosis in the general population: a systematic review and
meta-analysis, British Journal of Dermatology, Volume 190, Issue 4,
April 2024, Pages 465–476, https://doi.org/10.1093/bjd/ljad371
8
Balcere A, Rone Kupfere M, Čēma I, Krūmiņa A. (2019). Prevalence,
Discontinuation Rate, and Risk Factors for Severe Local Site Reactions
with Topical Field Treatment Options for Actinic Keratosis of the Face
and Scalp. Medicina (Kaunas, Lithuania), 55(4), 92.
https://doi.org/10.3390/medicina55040092
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Contacts
Investor Contact:
Rubedo Chief Business Officer Ali Siam
alisiam@rubedolife.com
781-974-9559
Media Contact:
Peter Collins
p.collins@togorun.com
908-499-1200
