Full Press Release Details
VYNE Therapeutics Announces Positive Phase 1b
Efficacy Data for FMX114 from Phase 1b/2a Trial for the Treatment of Mild-to-Moderate Atopic Dermatitis
N.J., April 7, 2022 -- VYNE Therapeutics Inc. (Nasdaq: VYNE) ("VYNE" or the "Company"), a biopharmaceutical
company developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced
positive efficacy results from the Phase 1b segment of a Phase 1b/2a clinical trial evaluating FMX114 for the treatment of mild-to-moderate
atopic dermatitis ("AD").
FMX114 is VYNE's proprietary investigational
combination gel formulation of tofacitinib and fingolimod that is designed 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.
The objective of the Phase 1b study segment was
to evaluate the preliminary clinical safety, dermal tolerance and pharmacokinetics of FMX114 and vehicle when topically applied to individual
qualifying AD lesions for 2 weeks. Efficacy was also assessed over the two-week treatment period.
At the study baseline visit, each subject (N=4)
had two AD lesions of comparable severity and extent based on the Atopic Dermatitis Severity Index ("ADSI") scoring assessment1.
Target lesions were randomized and treated twice daily with either FMX114 or vehicle gel.
Efficacy data for the Phase 1b segment of the
trial was assessed based on the absolute and percent change relative to baseline in ADSI score at week 2.
In addition, the effect of FMX114 on reducing pruritus (itch) was also
assessed using the worst pruritus Numerical Rating Scale ("NRS").
Dr. Iain Stuart, Chief Scientific Officer
of VYNE, stated, "We are encouraged by these early efficacy results from this Phase 1b segment of the trial showing that, based
on ADSI scoring, FMX114 treatment demonstrated a statistically significant improvement of the signs and symptoms of AD in 2 weeks. We
look forward to topline results from the Phase 2a segment of the study in the second quarter."
The FMX114 Phase 1b/2a 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 Phase 1b segment enrolled four subjects and the
Phase 2a segment of the study is expected to enroll up to 25 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.
During the Phase 1b segment, four subjects were
initially treated twice daily with FMX114 and vehicle for up to two weeks to evaluate preliminary safety of FMX114 and the pharmacokinetics
of each component (tofacitinib, fingolimod and the active metabolite, fingolimod 1-phosphate). There were no meaningful differences between
FMX114 treatment and vehicle-treated lesions at baseline, according to ADSI, TLSS, pruritus NRS and lesion size.
The 25 subjects in the Phase 2a segment 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.
FMX114 is VYNE's proprietary investigational
combination gel formulation of tofacitinib and fingolimod. The product is designed to address both the source and cause of inflammation
in AD through a combination of tofacitinib (a Janus kinase inhibitor) that acts with cells to reduce inflammation by inhibiting cytokine
release from inflammatory cells2) and fingolimod (a Sphingosine 1-phosphate receptor modulator) that acts outside of cells
to reduce inflammation by inhibiting migration of inflammatory cells3. In addition, fingolimod may also directly support skin
barrier recovery because it is known to upregulate filaggrin, a protein that plays an important role in the skin's barrier function4,5.
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.
1. The Atopic Dermatitis Severity Index (ADSI)
comprises an assessment of erythema, pruritus, exudation, excoriation, and lichenification, each on a scale of 0 to 3 to give a maximum
score of 15. Van Leent EJMGr ber MThurston MWagenaar ASpuls PIBos JD Effectiveness of the ascomycin macrolactam SDZ ASM 981 in the
topical treatment of atopic dermatitis. Arch Dermatol. 1998;134805- 809.
2. Schwartz DM, Kanno Y, Villarino A, Ward M,
GadinaM and O'Shea JJ, Nat Rev Drug Discov. 2017 Dec 28; 17(1):78.
3. Czeloth N, Bernhardt G, Hofman F, Genth H and
Forster R, J Immunol,2005 Sep; 175(5):2960-2967.
4. Allende ML, Sipe LM, TuymetovaG, Wilson-HenjumKL,
Chen W and ProiaRL, J Biol Chem. 2013 Jun 21; 288(25): 18381-18391.
5. Tsuji T, OkunoS, Kuroda A, HamazakiJ, ChikamiT,
Sakurai S, Yoshida Y, BannoR, Fujita T and Kohno T, Allerg. Int., 2016; 65: 172-179.
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 licensed from In4Derm Limited. The BET inhibitor
platform includes lead programs VYN201 (pan-BETi) and VYN202 (selective-BETi) and access to a library of (BET) domain inhibitors for the
potential treatment of immuno-inflammatory conditions.
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
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 timing, 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 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 enroll patients and progress clinical trials; 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,
including Nasdaq's continued listing rules. For a discussion of other risks and uncertainties, and other important factors, any