tofacitinib/fingolimod (FMX114) / Vyne Therap - LARVOL DELTA

Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management of psoriasis with systemic nonbiologic therapies (PubMed) - "Additionally, we discuss newer therapies, including tofacitinib and apremilast, and briefly touch on a number of other medications, including fumaric acid esters (used outside the United States) and therapies that are no longer widely used for the treatment of psoriasis (ie, hydroxyurea, leflunomide, mycophenolate mofetil, thioguanine, and tacrolimus)."

Clinical guideline • Psoriasis

Combining a Tyk2 inhibitor with a JAKi in RA? (RheumNow) - "There have been several observational studies of treatment in rheumatoid arthritis (RA) using another JAKi after an initial one fails. The JAK Pot study combined several registries and it appeared that in RA patients, there was a treatment response switching from one JAKi to another....We also need to wait and see if the strikingly positive results where the new molecule exceeded the performance of an established JAK inhibitor are reproduced in the phase III study."

Online posting

VYNE Therapeutics Reports Year-End 2022 Financial Results and Provides Business Update (GlobeNewswire) - P1b/2a | N=21 | NCT04927572 | Sponsor: Vyne Therapeutics Inc. | "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 atopic dermatitis ('AD'). Based on the Phase 2a results and subsequent analysis of a two-week open label extension period, the Company believes that FMX114 may have an improved overall treatment effect on patients with more severe disease at baseline, and that FMX114 may have increased potential to effectively treat patients with more moderate-to-severe AD. The Company is evaluating partnering opportunities for this program and intends to focus its resources on the BET inhibitor development programs."

Licensing / partnership • P2a data • Atopic Dermatitis • Dermatology • Immunology

VYNE Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Update (Yahoo News) - P1b/2a | N=36 | NCT04927572 | Sponsor: Vyne Therapeutics Inc. | "Expanded analysis of FMX114 Phase 2a trial results suggests FMX114 may have the potential to effectively treat patients with moderate-to-severe atopic dermatitis; VYNE currently evaluating development strategy for FMX114....Additionally, data received from the two-week open label extension during which both AD lesions of participating patients were treated with FMX114 showed that efficacy results continued to develop beyond week 4 of the clinical trial and that the separation of treatment effect for lesions treated with FMX114 as compared to lesions treated with vehicle increased for lesions that had a higher ADSI score at baseline. Accordingly, the Company believes that FMX114 may have an improved overall treatment effect on patients....In light of these analyses, the Company is currently evaluating its development strategy for FMX114."

P2a data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

Comparison of the safety and efficacy of fingolimod and tofacitinib in the zebrafish model of colitis. (PubMed, Food Chem Toxicol) - "Given the better efficacy of fingolimod, it is worth translating the effectiveness and safety of S1PR modulators into IBD patients and comparing them with TKIs in head-to-head studies; albeit, their toxicity should not be overlooked."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • MYD88 • TNFA

Safety, Pharmacokinetics and Efficacy of FMX114 Versus Vehicle in Adults With Atopic Dermatitis (clinicaltrials.gov) - P1/2 | N=21 | Completed | Sponsor: Vyne Therapeutics Inc. | Recruiting ➔ Completed | N=36 ➔ 21 | Trial completion date: Mar 2022 ➔ Aug 2022 | Trial primary completion date: Mar 2022 ➔ Aug 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

VYNE Therapeutics Reports Second Quarter 2022 Financial Results (GlobeNewswire) - "VYNE Therapeutics Inc...today announced financial results for the three and six months ended June 30, 2022....VYNE's research and development expenses for the three months ended June 30, 2022 were $4.1 million compared to $5.0 million for the three months ended June 30, 2021, representing a decrease of $0.9 million, or 18.6%. The decrease is mainly driven by lower spending on FMX114 and other research development activities..."

Commercial • Atopic Dermatitis • Dermatology • Immunology

VYNE Therapeutics Announces Results from its Phase 2a Trial of FMX114 for the Treatment of Mild-to-Moderate Atopic Dermatitis (GlobeNewswire) - P1b/2a | N=36 | NCT04927572 | Sponsor: Vyne Therapeutics Inc. | "VYNE Therapeutics...today announced results from the Phase 2a segment of a Phase 1b/2a clinical trial evaluating FMX114 for the treatment of mild-to-moderate atopic dermatitis ('AD').Study VY2021-01 did not meet its primary endpoint based on the absolute and percent change relative to baseline in the Atopic Dermatitis Severity Index ('ADSI')....Efficacy data for the Phase 2a trial was measured based on the absolute and percent change relative to baseline in the ADSI scoring assessment1 at week 4....'We’re obviously very disappointed by the outcome of this trial for FMX114.'...The Company expects to report cash and cash equivalents of approximately $43 million as of June 30, 2022. Additionally, the Company is entitled to receive a $5.0 million payment in January 2023 in connection with the sale of the MST franchise."

Commercial • P2 data • Atopic Dermatitis • Immunology

VYNE Therapeutics Completes Enrollment in Phase 2a Trial of FMX114 for the Treatment of Mild-to-Moderate Atopic Dermatitis (GlobeNewswire) - "VYNE Therapeutics Inc...announced the completion of enrollment in the Phase 2a study of FMX114 for the treatment of mild-to-moderate atopic dermatitis ('AD')....With enrollment now completed, the Company expects to report top-line efficacy results in approximately 6 to 8 weeks."

P2a data • Atopic Dermatitis • Immunology

Comparison of the Safety and Efficacy of Tofacitinib and Fingolimod in TNBS-Induced Colitis Model in Adult Zebrafish: The Role of Myd88/NF-κB/TNF-α Signaling Pathway. (PubMed, FASEB J) - "Resultantly, we revealed that these medications may suppress canonical and non-canonical NF-κB pathways through targeting toll-like receptors and MyD88. Given the better efficacy and multi-targeted action of fingolimod, it worth to focus on sphingosine-1 phosphate receptor modulators in clinical trials of UC and compare them with other classes of medications; albeit, their ecotoxicity aspect should not be overlooked."

Journal • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • MYD88 • TNFA

VYNE Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "VYNE Therapeutics Inc...today announced financial results for the quarter ended March 31, 2022 and provided a business update.... VYNE's research and development expenses for the three months ended March 31, 2022 were $4.5 million compared to $4.3 million for the three months ended March 31, 2021, representing an increase of $0.2 million, or 4.6%. The increase is primarily related to an increase in expenses associated with development of VYN201 of approximately $1.7 million, partially offset by a decrease in personnel costs of $0.7 million and a decrease in expenses for FMX114 of $0.6 million."

Commercial • Atopic Dermatitis • Immunology

VYNE Therapeutics Announces Positive Phase 1b Efficacy Data for FMX114 from Phase 1b/2a Trial for the Treatment of Mild-to-Moderate Atopic Dermatitis (GlobeNewswire) - P1/2a | N=36 | NCT04927572 | Sponsor: Vyne Therapeutics Inc. | "VYNE Therapeutics Inc...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....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. Mean ADSI scores for FMX114 and vehicle treated lesions were 7.8 and 8.0, respectively, at baseline. Mean reduction in ADSI score from baseline was -6.3 (-81.4% mean reduction) for FMX114 treated lesions compared to -4.3 (-54.3% mean reduction) for vehicle treated lesions at week 2 (p=0.004, LOCF, ITT)..."

P1 data • Atopic Dermatitis • Immunology

VYNE Therapeutics Reports Year-End 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - P1b | N=36 | VY2021-01 (NCT04927572) | Sponsor:Vyne Therapeutics Inc.| "We completed the divestiture of our topical minocycline MST franchise in January, reported positive Phase 1b safety data for FMX114 and released a series of promising preclinical data for our InhiBETTM inhibitor platform...VYNE has reported the results of preclinical studies and Phase 1b safety and pharmacology data....In a preclinical model of AD, FMX114 demonstrated comparable efficacy to a commonly used potent topical steroid, triamcinolone as measured by the reduction in modified atopic dermatitis index score (mADI), with improved dermal tolerability as measured by animal body weight....VYNE expects to release top line Phase 2a safety and efficacy results in the second quarter of 2022."

New P2 trial • P1 data • Atopic Dermatitis • Immunology

VYNE Therapeutics Announces Phase 1b Data for FMX114 from Phase 1b/2a Trial for the Treatment of Mild-to-Moderate Atopic Dermatitis (GlobeNewswire) - P1/2, N=36; NCT04927572; Sponsor: Vyne Therapeutics Inc; "VYNE Therapeutics Inc...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)....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....Both FMX114 and vehicle gel treatments were generally well-tolerated, and no serious adverse events were recorded during study conduct....The mean plasma Cmax of tofacitinib calculated on treatment day 1 and day 14 were approximately 50-fold and 1500-fold lower, respectively, when compared to the equivalent data for the lowest commercially available adult oral dose of tofacitinib (XELJANZ 5mg BD)..."

Enrollment status • P1 data • Atopic Dermatitis • Immunology

Safety, Pharmacokinetics and Efficacy of FMX114 Versus Vehicle in Adults With Atopic Dermatitis (clinicaltrials.gov) - P1/2; N=36; Recruiting; Sponsor: Vyne Therapeutics Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

VYNE Therapeutics Enrolls First Patient in Clinical Trial of FMX114 for the Treatment of Mild-to-Moderate Atopic Dermatitis (GlobeNewswire) - "VYNE Therapeutics Inc...today announced that it has enrolled the first patient in its Phase 1b/2a clinical trial evaluating FMX114 for the treatment of mild-to-moderate atopic dermatitis (AD)....'Anticipate topline results early in the first quarter of next year'. 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 31 subjects....The enrollment criteria specifies that subjects must have two comparable target AD lesions for treatment upon entry....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."

Enrollment status • P1/2 data • Atopic Dermatitis • Immunology

Pharmacokinetics, Efficacy and Safety of FMX114 Versus Vehicle in Adults With Atopic Dermatitis (clinicaltrials.gov) - P1/2; N=36; Not yet recruiting; Sponsor: Vyne Therapeutics Inc.; Phase classification: P2a ➔ P1/2; N=25 ➔ 36

Clinical • Enrollment change • Phase classification • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

VYNE Therapeutics Reports Second Quarter 2021 Financial Results and Announces New Strategic Direction to Develop Treatments for Immunological and Inflammatory Diseases (GlobeNewswire) - "VYNE plans to continue investing in FMX114...for the treatment of mild to moderate atopic dermatitis. The Company remains on track to enroll the first patient in a Phase 2a proof of concept study in 3Q 2021, and topline results are expected by the end of this year."

P2a data • Trial initiation date • Atopic Dermatitis • Immunology

Efficacy and Safety of FMX114 Versus Vehicle in Adults With Atopic Dermatitis (clinicaltrials.gov) - P2a; N=25; Not yet recruiting; Sponsor: Vyne Therapeutics Inc.

New P2a trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology