serlopitant (JTS 661) / Vyne Therap - LARVOL DELTA

Disease Severity and Pruritus Treatment Outcomes in Prurigo Nodularis: A Systematic Review of Randomized-Controlled Trials (CDA 2025) - "Treatments included nemolizumab (49.7%, 560/1127), serlopitant (31.1%, 351/1127), dupilumab (13.6%, 153/1127), nalbuphine (3.5%, 40/1127) and vixarelimab (2.0%, 23/1127). The greatest proportion of patients achieving IGA score of 0/1 compared to control was achieved by nemolizumab 0.5 mg/kg Q4W (67.6%; placebo 14.3%; n=70; duration 12-weeks), dupilumab 300 mg Q2W (48.0%; placebo 18.4%; n=151; duration 24-weeks) and nemolizumab 30-60 mg Q4W (31.9%; placebo 9.1%; n=560; duration 16-weeks). Conclusions Nemolizumab and dupilumab were the most effective at reducing itch and PN disease severity assessed by WI-NRS and IGA scores."

Clinical • Review • Dermatology • Immunology • Prurigo Nodularis • Pruritus

Systemic neurokinin-1 receptor antagonists mitigate chronic pruritus: A systematic review and meta-analysis. (PubMed, J Eur Acad Dermatol Venereol) - "Our study suggests that systemic NK1R antagonists, particularly serlopitant and aprepitant, hold a modest therapeutic effect for treating chronic pruritus, particularly in patients with nonmalignant dermatological conditions. Thus, clinicians can consider NK1R antagonists to effectively interrupt itch signalling in patients with chronic pruritus."

Journal • Retrospective data • Review • Dermatology • Pruritus

From the Cochrane Library: Interventions for Chronic Pruritus of Unknown Origin. (PubMed, JMIR Dermatol) - No abstract available

Journal • Dermatology • Pruritus

Evaluation of antipruritic effects of serlopitant, a neurokinin 1 receptor antagonist, in patients with epidermolysis bullosa: A phase 2 randomized controlled trial. (PubMed, J Eur Acad Dermatol Venereol) - No abstract available

Journal • P2 data

Atypical Presentation of Generalized Eruptive Keratoacanthoma of Grzybowski Mimicking Prurigo Nodularis: Remission with Low-Dose Acitretin (EADV-Sp 2023) - "Results A 65-year-old Caucasian woman presented to the dermatology department with a diagnosis of PN and a 12-year history of persistent skin lesions that were refractory to treatment with serlopitant, glucocorticosteroids, topical antibiotics, cryotherapy or UVB 311 phototherapy. It was only until a full nodule excision was performed that we were able to reach the correct diagnosis and provide the right treatment, raising the possible question of considering such biopsies as a gold standard for the diagnosis of the disease. Though GEKA developed with PN has been described before, this is the first report of GEKA with cutaneous manifestations consistent with PN and histopathology results consistent with GEKA."

Clinical • Dermatology • Immunology • Oncology • Pain • Prurigo Nodularis • Pruritus • Skin Cancer

A Neurokinin-1 Receptor Antagonist for the Treatment of Pruritus in Patients With Epidermolysis Bullosa (clinicaltrials.gov) - P2 | N=28 | Completed | Sponsor: Stanford University | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Pruritus

Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis (clinicaltrials.gov) - P3; N=295; Completed; Sponsor: Menlo Therapeutics Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion

Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis (clinicaltrials.gov) - P3; N=285; Completed; Sponsor: Menlo Therapeutics Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion

A Neurokinin-1 Receptor Antagonist for the Treatment of Pruritus in Patients With Epidermolysis Bullosa (clinicaltrials.gov) - P2 | N=29 | Active, not recruiting | Sponsor: Stanford University | Recruiting ➔ Active, not recruiting | Trial primary completion date: Apr 2022 ➔ Dec 2021

Enrollment closed • Trial primary completion date • Dermatology • Pruritus

A Neurokinin-1 Receptor Antagonist for the Treatment of Pruritus in Patients With Epidermolysis Bullosa (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: Stanford University; Trial primary completion date: Sep 2021 ➔ Apr 2022

Clinical • Trial primary completion date • Dermatology • Pruritus

Benefits and harms of NK R antagonists in pruritus: A systematic review and meta-analysis. (PubMed, Dermatol Ther) - "However, the benefit and risk profile of NK1R antagonists- serlopitant and aprepitant for the treatment of pruritus remains unclear...There is promising high-quality evidence regarding the efficacy of serlopitant on pruritus. More large-sample randomized controlled trials with appropriate treatment regimen are urgently needed to further evaluate the effectiveness of aprepitant in pruritus."

Clinical • Journal • Retrospective data • Review • Dermatology • Pruritus

Validation of Psychometric Properties of the Itch Numeric Rating Scale for Pruritus Associated With Prurigo Nodularis: A Secondary Analysis of a Randomized Clinical Trial. (PubMed, JAMA Dermatol) - P2 | "This secondary analysis is based on a secondary end point of a phase 2 randomized clinical trial of serlopitant for treatment of pruritus associated with PN...Results from this secondary analysis show that the itch NRS items WI-NRS and AI-NRS have good psychometric properties for pruritus associated with PN and should be considered acceptable tools for assessing pruritus in future clinical trials of PN. ClinicalTrials.gov Identifier: NCT02196324."

Clinical • Journal • Dermatology • Pruritus

Menlo Therapeutics Announces Corporate Name Change to VYNE Therapeutics (GlobeNewswire) - "Menlo Therapeutics Inc....announced today it is changing its corporate name to VYNE Therapeutics Inc. ('VYNE Therapeutics'). In connection with the name change, the Company’s common stock will begin trading under a new ticker symbol 'VYNE'. The name and ticker change will be effective at the opening of trading, Tuesday, September 8, 2020. In addition, VYNE Therapeutics will ring the Nasdaq closing bell on September 8, at 4:00 PM ET." "

Commercial • Dermatology • Pruritus

Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch) (clinicaltrials.gov) - P3; N=558; Terminated; Sponsor: Menlo Therapeutics Inc.; Trial completion date: May 2021 ➔ Jun 2020; Active, not recruiting ➔ Terminated; Trial primary completion date: May 2021 ➔ Apr 2020; No longer pursuing development of serlopitant

Clinical • Trial completion date • Trial primary completion date • Trial termination • Atopic Dermatitis • Dermatitis • Dermatology • Dermatopathology • Immunology • Pruritus • Psoriasis

Menlo Reports Second Quarter 2020 Financial Results and Provides Business Update (GlobeNewswire) - "Our research and development expenses for the three months ended June 30, 2020 were $13.1 million...increased by $4.5 million...clinical and manufacturing costs related to serlopitant increased by $4.1 million which was acquired in the merger with Foamix Pharmaceuticals...Our research and development expenses for the six months ended June 30, 2020 were $29.1 million...In addition, clinical and manufacturing costs related to serlopitant increased by $7.4 million which was acquired in the merger..."

Commercial • Dermatology • Pruritus

Interventions for chronic pruritus of unknown origin. (PubMed, Cochrane Database Syst Rev) - "We found lack of evidence to address our review question: for most of our interventions of interest, we found no eligible studies. The neurokinin 1 receptor (NK1R) antagonist serlopitant was the only intervention that we could assess. One study provided low-certainty evidence suggesting that serlopitant may reduce pruritus intensity when compared with placebo. We are uncertain of the effects of serlopitant on other outcomes, as certainty of the evidence is very low. More studies with larger sample sizes, focused on patients with CPUO, are needed. Healthcare professionals, patients, and other stakeholders may have to rely on indirect evidence related to other forms of chronic pruritus when deciding between the main interventions currently used for this condition."

Journal • Review • Acne Vulgaris • Atopic Dermatitis • CNS Disorders • Depression • Dermatitis • Dermatology • Dermatopathology • Immunology • Pruritus • Psoriasis

Menlo reports first quarter 2020 financial results and provides business update (GlobeNewswire) - "Our research and development expenses for the three months ended March 31, 2020 were $16.0 million, representing an increase of $5.2 million, or 48%...In addition, clinical and manufacturing costs related to serlopitant, which was acquired in the transaction combining Menlo with Foamix (the 'Merger'), increased by $2.2 million, offset by a decrease of $2.2 million..."

Commercial • Dermatology • Pruritus

Menlo Therapeutics announces results from two phase 3 clinical trials of serlopitant for the treatment of pruritus associated with prurigo nodularis (Menlo Therapeutics Press Release) - P3, N=285; NCT03546816; P3, N=295; NCT03677401; Sponsor: Menlo Therapeutics; "Menlo Therapeutics...today announced top line results from two Phase 3 clinical trials evaluating the safety and efficacy of once daily oral serlopitant for the treatment of pruritus (itch) associated with prurigo nodularis (PN), studies MTI-105 and MTI-106....Study MTI-105 and Study MTI-106 did not meet their respective primary endpoint of demonstrating statistically significant reduction in pruritus in patients treated with serlopitant compared to placebo based upon a 4-point improvement responder analysis....At this point, we do not intend to further pursue serlopitant."

Discontinued • P3 data

Menlo Therapeutics and Foamix Pharmaceuticals Complete Merger, Creating a Combined Company Focused on the Development and Commercialization of Therapeutics for Dermatologic Indications (GlobeNewswire, Menlo Therapeutics Inc.) - "Menlo Therapeutics...announced today the completion of its merger with Foamix Pharmaceuticals...following the satisfaction of all closing conditions required by the merger agreement....These contingent stock rights potentially allow Foamix shareholders to receive additional shares of Menlo common stock based on the results of Menlo’s Phase 3 trials of serlopitant for the treatment of pruritus associated with prurigo nodularis, as more fully described in the companies’ joint proxy statement/prospectus on Form S-4."

Clinical • Clinical data • Commercial • M&A

Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch) (clinicaltrials.gov) - P3; N=558; Active, not recruiting; Sponsor: Menlo Therapeutics Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Menlo Therapeutics Announces Results from Phase 2 Trial of Serlopitant in Patients with Chronic Pruritus of Unknown Origin (GlobeNewswire, Menlo Therapeutics Inc.) - "Menlo Therapeutics...today announced results from its Phase 2 clinical trial evaluating the safety and efficacy of once daily oral serlopitant for the treatment of chronic pruritus (itch) of unknown origin (CPUO). The trial, which included 233 patients, did not meet its primary endpoint to show a statistically significant reduction in pruritus in patients treated with serlopitant compared to placebo based upon a 4-point improvement responder analysis....Results from the company’s Phase 3 trials for the treatment of pruritus associated with prurigo nodularis (PN) are expected in March or April of this year."

Clinical • Clinical data

Menlo Therapeutics to host conference call tomorrow to discuss results from phase 2 trial of serlopitant in patients with chronic pruritus of unknown origin (GlobeNewswire, Menlo Therapeutics Inc.) - "Menlo Therapeutics...announced it will host a conference call and webcast on Wednesday, February 26, 2020 at 8:30 am ET (5:30 am PT) to discuss results from the Phase 2 trial of serlopitant in patients with chronic pruritus of unknown origin. The company’s management will be joined on the call by Foamix’s chief executive officer, David Domzalski."

P2 data

Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin (clinicaltrials.gov) - P2; N=233; Completed; Sponsor: Menlo Therapeutics Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion

Serlopitant for Psoriatic Pruritus: a Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial. (PubMed, J Am Acad Dermatol) - P2; "Serlopitant significantly reduced pruritus associated with mild-to-moderate psoriasis, supporting continued development of serlopitant for this patient population."

Clinical • Journal • P2 data

Menlo Therapeutics Announces Publication of Phase 2 Results for Serlopitant for the Treatment of Pruritus Associated with Psoriasis in the Journal of the American Academy of Dermatology (GlobeNewswire, Menlo Therapeutics Inc.) - P2, N=204; NCT03343639; Sponsor: Menlo Therapeutics Inc.; "Menlo Therapeutics Inc....today announced the publication of the company’s Phase 2 trial of serlopitant for the treatment of pruritus associated with psoriasis in the Journal of the American Academy of Dermatology (JAAD). The trial results were published in the February 3, 2020, online JAAD and demonstrate that serlopitant significantly reduced pruritus in patients with psoriasis and was well-tolerated."

P2 data