Company Product Description Indication Status
Phase II
Arcutis Biotherapeutics Inc., of Westlake Village, Calif. Roflumilast (topical foam) PDE 4 inhibitor Psoriasis In phase IIb study, improvement seen as early as 2 weeks after treatment started; primary endpoint of scalp IGA success at week 8 met by 59.1% of participants for study drug vs. 11.4% for vehicle (p<0.0001), with 34.3% for roflumilast and 3.4% for vehicle rated clear at week 8; body IGA success at week 8 achieved by 40.3% and 6.8%, respectively (p<0.0001)
Arena Pharmaceuticals Inc., of San Diego Etrasimod Once-daily, oral S1P modulator Atopic dermatitis Additional data demonstrated statistical significance in both clinician and patient reported outcomes in the etrasimod 2-mg treatment group of the ADVISE phase IIb clinical trial; patient reported outcomes in this treatment group were improved as early as 2 weeks after treatment was initiated
Avillion LLP, of London Sonelokimab (M-1095)  IL-17 antagonist Psoriasis Data from trial that met primary efficacy endpoint based on IGA at week 12 in people with chronic disease published in The Lancet 
Incyte Corp., of Wilmington, Del. Ruxolitinib cream JAK inhibitor Vitiligo New findings showed a randomized phase II study met its primary endpoint, demonstrating that significantly more patients treated with ruxolitinib cream for 24 weeks achieved a ≥50% improvement from baseline in the facial vitiligo area scoring index score compared to patients treated with a vehicle control 
Nicox SA, of Sophia Antipolis, France NCX-4251 (fluticasone) Glucocorticoid receptor agonist Blepharitis  Phase IIb Mississippi trial reached 50% enrollment with 102 participants and remains on track for top-line results in 4Q 2021
Novavax Inc., of Gaithersburg, Md. R-21 vaccine Protein subunit vaccine with Matrix-M adjuvant Malaria infection Data from phase IIb trial in 450 children 5 to 17 months that showed 77% efficacy for higher adjuvant dose published in Preprints with The Lancet; candidate developed in collaboration with and licensed to Serum Institute of India
Verona Pharma plc, of London Ensifentrine (metered-dose inhaler) Dual PDE 3/PDE 4 inhibitor COVID-19 infection Study in 45 participants hospitalized with infection showed ensifentrine was safe and well-tolerated in people with SARS-CoV-2; trial not designed or sized to show efficacy and no efficacy benefit seen when ensifentrine added to standard of care
Phase III
Boehringer Ingelheim Pharmaceuticals Inc., unit of Boehringer Ingelheim GmbH, of Ingelheim, Germany Cyltezo (adalimumab-adbm) TNF inhibitor Psorasis Voltaire-X study showed that switching several times from Humira (adalimumab, Abbvie Inc.) to Cyltezo produced similar outcomes in pharmacokinetics, efficacy, immunogenicity and safety in people with moderate to severe chronic disease, meeting primary endpoint at 32 weeks and supporting interchangeability application
Brickell Biotech Inc., of Boulder, Colo. Sofpironium bromide gel Acetylcholine receptor antagonist Hyperhidrosis Argyle long-term safety study in 300 participants showed daily treatment with 5% or 15% doses was well-tolerated over 48 weeks of treatment; efficacy assessments showed clinically meaningful and sustained improvement in sweat severity through 48 weeks of treatment
Bristol Myers Squibb Co., of New York Deucravacitinib Oral, selective TYK2 inhibitor Moderate to severe plaque psoriasis Results from 2 pivotal phase III trials showed both met co-primary endpoints vs. placebo, with significantly more patients achieving Psoriasis Area and Severity Index 75 response and a static Physician's Global Assessment score of clear or almost clear after 16 weeks of treatment; it was well-tolerated with a low rate of discontinuation due to adverse events
Eli Lilly and Co., of Indianapolis Olumiant (baricitinib) Dual Jak1/Jak2 inhibitor Atopic dermatitis Analysis of Breeze-AD5 data showed improvement from baseline in EASI of 25.3% for study drug vs. 7.2% for placebo at 1 week and 50.9% vs. 24.0%, respectively, at 4 weeks; improvement from baseline in Itch Numeric Rating Scale at 1 week was 13.5% vs. -0.2% and at 4 weeks was 29.0% vs. 12.5%, respectively
Incyte Corp., of Wilmington, Del. Ruxolitinib cream JAK inhibitor Atopic dermatitis (AD) Findings from 3 pooled analyses of its randomized, double-blind phase III studies showed ruxolitinib cream 0.75% applied twice daily (BID) and ruxolitinib cream 1.5% BID both demonstrated greater improvement compared to vehicle in all analyzed efficacy endpoints; higher responses were observed in patients with more severe disease; a subsequent analysis found higher rates of clinical responses with ruxolitinib cream vs. vehicle in severe AD patients
Janssen Pharmaceutical Cos., unit of Johnson & Johnson, of New Brunswick, N.J. Tremfya (guselkumab) IL-23 inhibitor Plaque psoriasis; psoriatic arthritis In Voyage 2 study, Tremfya showed durable, complete skin clearance rates in most adults with moderate to severe psoriasis through 5 years (252 weeks), with 55.5% achieving IGA score of 0 and 53% achieving PASI 100 response; Discover-1 and -2 trials showed improved disease activity and axial symptoms in adults with active psoriatic arthritis through 52 weeks
Novartis AG, of Basel, Switzerland Zolgensma (onasemnogene abeparvovec) SMN1 gene stimulator Spinal muscular atrophy Phase IIIb Smart study will assess gene therapy in 24 young children with SMA who weigh ≥ 8.5 kg and ≤ 21 kg following one-time intravenous infusion; efficacy endpoints include change from baseline in motor milestones
UCB SA, of Brussels Bimekizumab Dual IL-17A/IL-17F inhibitor Plaque psoriasis New England Journal of Medicine published new results from phase IIIb Be Radiant study in adults with moderate to severe disease; study met primary endpoint, with 61.7% treated with study drug achieving complete skin clearance, measured by PASI 100 at week 16, vs. 48.9 for Cosentyx (secukinumab, Novartis, AG; p<0.001)
Phase IV
EMD Serono, unit of Merck KGaA, of Darmstadt, Germany Mavenclad (cladribine) Adenosine deaminase inhibitor Multiple sclerosis Magnify-MS sub-study analysis showed potential to fight infections and boost vaccine response in people with relapsing disease; reduction of memory B cells seen as early as 1 month after treatment initiation, with lowest levels sustained for up to 12 months; naïve B cells began to recover immediately

Notes

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