Full Press Release Details
Announces Phase 1b Data for FMX114 from Phase 1b/2a Trial for the Treatment of Mild-to-Moderate Atopic Dermatitis
Systemic bioavailability of JAK inhibitor (tofacitinib)
and S1P receptor modulator (fingolimod) in topical formulation substantially lower compared to oral equivalents
Mean Cmax of tofacitinib 50-fold
and 1500-fold lower at Day 1 and 14 of study compared to the lowest commercially available oral alternative
Findings from Phase 1b safety portion of study
support trial continuation
Topline Phase 2a results expected in Q1 2022
BRIDGEWATER, N.J., January 19th, 2022 -- VYNE
Therapeutics Inc. (Nasdaq: VYNE) ("VYNE" or the "Company") today announced that it has completed the Phase 1b
portion of a Phase 1b/2a clinical trial evaluating FMX114 for the treatment of mild-to-moderate atopic dermatitis (AD) (Study VY2021-01).
FMX114 is VYNE's proprietary investigational combination gel formulation of tofacitinib and fingolimod. The product is being developed
to address both the source and cause of inflammation in AD. FMX114 has the potential to be the first topical combination product for the
treatment of AD as well as the first topical product in clinical development that utilizes the sphingosine 1-phosphate receptor modulation
The objective of the Phase 1b portion of the study was to evaluate
the preliminary clinical safety, dermal tolerance and pharmacokinetics of FMX114 and vehicle gels when topically applied for up to 2 weeks
to individual qualifying atopic dermatitis lesions. The study planned to enroll up to 6 subjects with mild to moderate atopic dermatitis
in this Phase 1b safety portion. However, based on the data obtained from the first two completing subjects, the Human Research Ethics
Committee (HREC) in Australia overseeing the study agreed to reduce the enrollment number to 4 subjects with mild to moderate atopic dermatitis.
At the study baseline visit, each subject had two AD lesions of comparable
severity and extent based on the Atopic Dermatitis Severity Index (ADSI) scoring assessment and qualifying lesions were randomized to
either FMX114 or vehicle gel treatment. Adverse events, clinical laboratory results and local dermal tolerance data was collected throughout
subject participation in the study. Pharmacokinetics of tofacitinib, fingolimod and fingolimod 1-phosphate were evaluated based on blood/plasma
concentration data obtained from highly sensitive and validated bioanalytical methods.
Both FMX114 and vehicle gel treatments were generally well-tolerated,
and no serious adverse events were recorded during study conduct. Pharmacokinetics of tofacitinib, fingolimod and fingolimod 1-phosphate
are summarized below:
Dr. Iain Stuart, Chief Scientific Officer of VYNE, stated, "FMX114
was designed to deliver both active drugs efficiently to the skin while minimizing their respective systemic exposures. We are encouraged
by the results from the Phase 1b portion of study VY2021-01 and look forward to announcing top-line Phase 2a results later this quarter."
About Study VY2021-01 (ClinicalTrials.gov Identifier: NCT04927572)
The Phase 1b/2a study is a randomized, double-blinded trial designed
to compare the safety and efficacy of FMX114 gel with vehicle gel. The study is expected to enroll up to 31 subjects, with each subject
serving as their own control. The enrollment criteria specifies that subjects must have two comparable target AD lesions for treatment
upon entry. Participants will have FMX114 gel applied to one of these lesions and vehicle gel to the other. Up to six subjects will be
initially treated twice daily with FMX114 and vehicle for up to two weeks to evaluate preliminary safety of FMX114 and the pharmacokinetics
of tofacitinib, fingolimod and fingolimod 1-phosphate. A further 25 subjects will receive FMX114, and vehicle treatment applied twice
daily for four weeks in a double-blinded phase of the study to further evaluate safety, pharmacokinetics and efficacy. After completion
of this phase, these subjects may continue into a two-week open-label treatment phase and will be able to apply the active drug to both
lesions. The trial is being conducted in Australia in subjects with mild-to-moderate atopic dermatitis (clinicaltrials.gov link)
FMX114 is VYNE's proprietary investigational combination gel
formulation of tofacitinib and fingolimod. The product is being developed to address both the source and cause of inflammation in AD by
developing a distinct combination of tofacitinib (a Janus kinase inhibitor) aimed at reducing inflammation by inhibiting cytokine release
from inflammatory cells) and fingolimod (a Sphingosine 1-phosphate receptor modulator) which approaches the reduction of inflammation
by inhibiting migration of inflammatory cells, and in addition may also directly support skin barrier recovery. FMX114 has the potential
to be the first topical combination product for the treatment of AD as well as the first topical product in clinical development that
utilizes the sphingosine 1-phosphate receptor modulation mode of action.
About Atopic Dermatitis
Atopic dermatitis (AD) is a chronic, severe form of eczema that is
characterized by the appearance of dry, red, and itchy skin. AD most commonly affects the cheeks, arms, and legs. Flare ups often occur
and symptoms can worsen leading to more-intense itching and worsening of disease. AD flares are triggered by stress, temperature changes,
sweat, various skin irritants, and allergies. AD can have a wide-ranging impact on quality of life and there is a substantial monetary
burden from direct and indirect costs to this patient population. While AD occurs most often in childhood, it can develop at any point
in a person's lifetime and affects approximately 30 million people in the U.S. alone. Approximately 22 million of those diagnosed
are on treatment, with 19 million registering mild to moderate disease. According to Symphony Health data, there were over 7 million
prescriptions written in 2019 alone for the treatment of AD.
About VYNE Therapeutics Inc.
VYNE's mission is to improve the lives of patients by developing
proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions. The Company's unique
and proprietary pipeline includes FMX114 for the potential treatment of mild-to-moderate atopic dermatitis and access to a library of
bromodomain & extra-terminal (BET) domain inhibitors in both topical and oral forms for the potential treatment of major immuno-inflammatory
conditions and rare skin diseases.
For more information about VYNE Therapeutics Inc. or its investigational
products, visit www.vynetherapeutics.com. VYNE may use its website to comply with its disclosure obligations under Regulation
FD. Therefore, investors should monitor VYNE's website in addition to following its press releases, filings with the U.S. Securities
and Exchange Commission, public conference calls, and webcasts.
LifeSci Advisors, LLC
VYNE Therapeutics Inc.
Cautionary Statement Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including,
but not limited to, statements regarding the development and commercialization of VYNE's product candidate, FMX114, and other statements
regarding the future expectations, plans and prospects of VYNE. All statements in this press release which are not historical facts are
forward-looking statements. Any forward-looking statements are based on VYNE's current knowledge and its present beliefs and expectations
regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially
and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited
to: the outcome and cost of preclinical and clinical trials for current and future product candidates; determination by the FDA that results
from VYNE's preclinical and clinical trials are not sufficient to support registration or marketing approval of product candidates;
adverse events associated with the development and commercialization of FMX114 and VYNE's other product candidates; the COVID-19
pandemic and its impact on our business operations and liquidity, including our ability to progress a preclinical or clinical trial; the
size of the atopic dermatitis market; the potential patient base and commercial potential of FMX114 or any of VYNE's other product
candidates; risks of potential litigation by third-parties regarding infringement of third-party intellectual property; risks that VYNE's
intellectual property rights, such as patents, may fail to provide adequate protection, may be challenged and one or more claims may be
revoked or interpreted narrowly or will not be infringed; risks that any of VYNE's patents may be held to be narrowed, invalid or
unenforceable or one or more of VYNE's patent applications may not be granted and potential competitors may also seek to design
around VYNE's granted patents or patent applications; additional competition in the markets in which we compete; inability to raise
additional capital on favorable terms or at all; VYNE's ability to recruit and retain key employees; and VYNE's ability to
stay in compliance with applicable laws, rules and regulations. For a discussion of other risks and uncertainties, and other important
factors, any of which could cause VYNE's actual results to differ from those contained in the forward-looking statements, see the
section titled "Risk Factors" in VYNE's Annual Report on Form 10-K for the year ended December 31, 2020, as
well as discussions of potential risks, uncertainties, and other important factors in VYNE's subsequent filings with the U.S. Securities
and Exchange Commission. Although VYNE believes these forward-looking statements are reasonable, they speak only as of the date of this
announcement and VYNE undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances,
except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions