FDA Accepts BLA for Bimekizumab for Plaque Psoriasis
The FDA and the European Medicines Agency (EMA) have accepted the Biologics License Application (BLA) and Marketing Authorization Application (MAA), respectively, for bimekizumab (UCB) for the treatment of adults with moderate to severe plaque psoriasis.
The marketing application submissions for bimekizumab are based on data from a global Phase 3 clinical development program in psoriasis. All Phase 3 studies met their primary endpoints, demonstrating that bimekizumab-treated patients achieved superior skin clearance, at week 16, compared to those who received placebo and Humira (adalimumab) as measured by the Psoriasis Area and Severity Index (PASI 90) and an Investigator Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1).
All the Phase 3 studies met their ranked secondary endpoints. Two studies demonstrated superior total skin clearance at week 16, as measured by PASI 100, confirming the superiority of bimekizumab over existing biologic treatments Stelara (ustekinumab) and adalimumab. Bimekizumab was superior to placebo, ustekinumab, and adalimumab in achieving rapid response, defined as PASI 75 at week 4. Clinical responses were maintained up to one year in all studies. The safety profile of bimekizumab continues to be consistent with earlier clinical studies with no new safety signals identified.
Partner Therapeutics Moves Ahead with Phase 3 Study for Melanoma
Partner Therapeutics, Inc. is resuming enrollment in the National Cancer Institute (NCI)-sponsored ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) study of Leukine plus ipilumimab and nivolumab for melanoma following a successful planned interim analysis.
EA6141 (NCT02339571) is a randomized controlled study of Leukine (sargramostim, yeast derived rhu-GM-CSF) in combination with ipilimumab and nivolumab for the front line treatment of melanoma. The restart was based on results of ECOG-ACRIN’s planned interim efficacy and safety analysis of survival data from the first 250 patients enrolled in the study.
In September 2019, the FDA granted orphan drug status to Leukine for the potential treatment of stage IIb-IV melanoma.
“GM-CSF has unique immunomodulatory properties that have the potential to substantially benefit patients with cancer. I am particularly pleased, given the many years we have spent in understanding the role of GM-CSF in the laboratory and the clinical setting,” says Study Chair F. Stephen Hodi, MD, Director of the Center for Immuno-Oncology at Dana-Farber Cancer Institute in Boston, in a news release. “This study in the front line setting is intended to confirm and broaden the findings in the randomized Phase 2 trial EA1608, which demonstrated improved efficacy and toxicity when sargramostim was added to ipilimumab.”
ECOG-ACRIN launched the Phase 2/3 EA6141 study in September 2015. In the study, patients with stage III/IV unresectable melanoma are randomized to receive standard of care treatment with nivolumab and ipilimumab with or without sargramostim. The primary endpoint is overall survival. ECOG-ACRIN planned for the interim trial pause after 240 patients were enrolled, to assess efficacy. The group paused enrollment in June 2017 and the interim analysis is now complete. Based on the findings of the interim analysis, the ECOG-ACRIN Data Safety Monitoring Committee has given the go ahead to start the enrollment into the phase 3 portion of the study. The total planned enrollment is 600 patients. The study remains blinded and no data will be released until completion.
Allergan Aesthetics and Skinbetter Science Launch DREAM Initiative
Allergan Aesthetics, an AbbVie company, and Skinbetter Science have introduced a new long-term, educational initiative—DREAM: Driving Racial Equity in Aesthetic Medicine—to further the principles of racial and ethnic diversity, inclusion, respect and understanding in the fields of dermatology and plastic surgery.
Case studies and data relevant to darker skin tones are grossly underrepresented in current educational materials and textbooks, which can lead to under or misdiagnoses for black and brown patients. Allergan Aesthetics and Skinbetter Science endeavor to start to bridge this gap in dermatology and plastic surgery with The National Racial Equity Medical Residency Curriculum. This program is designed to assist students, faculty, and staff in dermatology and plastic surgery residency programs in identifying and addressing the risk of implicit bias in academic and clinical settings. This curriculum is being piloted at a leading university, with subsequent nationwide rollout planned thereafter. The DREAM Initiative is also sponsoring the development of The Spectrum of Dermatologic Disease, a comprehensive textbook photo atlas, which will present the characteristics of skin conditions across the full range of racial and ethnic skin types. The Spectrum of Dermatologic Disease, upon publication, will be disseminated to medical residents, faculty, and program libraries, and thereafter be available as a resource for clinical practitioners worldwide.
The DREAM Initiative plans to convene Forces of Beauty Summits to help identify different perceptions of beauty among racial and ethnic groups, so that media, aesthetic providers, and corporations can better understand and meet the aesthetic needs of all patients.
CLOSE UP with Florence Poizeau, PhD
Earlier research suggested that the interleukin (IL)-12/23 blocker ustekinumab (Stelara) may be linked to severe heart attacks or strokes following initiation of treatment, but follow-up studies did not show such a link. Still, Florence Poizeau, a PhD student at Rennes University Hospital in Rennes, France, and others were not content putting the matter to rest and conducted a case-time-control analysis to dig a bit deeper. They found that ustekinumab treatment was associated with an increased risk of acute coronary syndrome or stroke within the first six months of treatment in patients with a high baseline cardiovascular risk. Ms. Poizeau spoke to Practical Dermatology® about the study, which appears online in JAMA Dermatology, and the importance of screening and monitoring high-risk individuals who begin treatment with ustekinumab and other biologics.
WHY IS THIS TOPIC IMPORTANT TO STUDY?
Ms. Poizeau: A meta-analysis of randomized clinical trials reported in 2011 a potential risk of severe cardiovascular events (SCEs) within the first few months after the initiation of anti–IL-12/23p40 antibodies. Further cohort studies had been reassuring for long-term risk, but whether the initiation of ustekinumab treatment triggered SCEs in the first months of treatment had to be studied.
DESCRIBE THE RESEARCH AND YOUR FINDINGS.
Ms. Poizeau: We conducted a case-time-control analysis based on data from 9,290 patients with records in the French national health insurance database from 2010 to 2016. The initiation of ustekinumab treatment was associated with an increased risk of acute coronary syndrome or stroke within the first six months of treatment, in patients with a high baseline cardiovascular risk (from two cardiovascular risk factors or a history of cardiovascular event), but not in patients with a low baseline cardiovascular risk.
WHAT IS THE NEXT STEP?
Ms. Poizeau: The results of this case-time-control analysis suggest that ustekinumab should be prescribed with caution to patients at high cardiovascular risk. The same systematic strategy will be used to screen for early SCE among patients exposed to other newly developed biotherapies inhibiting the helper T cell subtype 17 pathway.
Suneva to Market and Distribute Neauvia’s Plasma IQ in North America
Suneva Medical, Inc. will market and distribute Neauvia Plasma IQ throughout North America as part of a new partnership.
The first Class 2 FDA-cleared plasma energy device, Plasma IQ delivers focused, controlled plasma energy to create microinjuries on the skin, renewing and restoring it. It is FDA cleared for the removal and destruction of skin lesions and the coagulation of tissue.
“This is an exciting partnership as Suneva Medical is well positioned to offer a unique technology to a number of providers looking for new aesthetic treatments that are safe and effective,” says Sean Wilson, CEO of Neauvia North America.
“We are looking forward to welcoming Plasma IQ to our ever-expanding portfolio of facial regenerative aesthetics products,” adds Pat Altavilla, CEO of Suneva Medical. “With the introduction of Plasma IQ, we continue our commitment to providing proven and validated innovations for aesthetic providers and their patients.”
Star Power: Dermatology Companies Get Celebrity Endorsements
Actress and Goop wellness guru Gwyneth Paltrow is the first global face of Merz Aesthetics’ Xeomin. In this role, Ms. Paltrow will be sharing details about what she does to look and feel her best, and will ask women to do the same on social media using #DareToSelfCare.
“Gwyneth and I have been friends born out of mutual respect, which began with a shared desire to be true to yourself and to embrace ones’ desire to look and feel your best—the definition of graceful aging,” adds Julius Few, MD, Founder of The Few Institute for Aesthetic Plastic Surgery in Chicago. “Like Gwyneth, more and more of my patients tell me they don’t want to look different—they just want the outside to reflect how they feel on the inside. Xeomin, which is backed by science, helps give their frown lines a smoother appearance.”
The heart of the campaign ties back to Ms. Paltrow’s philosophy on beauty, which is that women should give themselves the permission to do whatever they want to do in order to feel good. Ms. Paltrow and influencers will be encouraging women to take time for themselves and prioritize self-care, especially now.
Allergan Aesthetics, an AbbVie company, is partnering with actress Sarah Michelle Gellar who will share her CoolSculpting journey. As the international ambassador, Ms. Gellar will discuss why she turned to CoolSculpting to help her achieve her body contouring goals. The partnership launched internationally on September 2, 2020. In addition, Malin Akerman, Swedish-Canadian-American actress, model, and singer, is the newly anointed US Ambassador for Allergan Aesthetics’ Coolsculpting and Cooltone. Ms. Akerman is supporting two new body contouring campaigns and encouraging consumers to “Shape Your Moment with CoolSculpting” and purchase a $300 CoolSculpting gift card for only $150 now through November 30 or “Set The Tone with CoolTone” and purchase a $300 CoolTone gift card for only $150, now through December 31.
Novartis is launching PsO in the Know, a podcast series hosted by music icon Cyndi Lauper. PsO in the Know will feature a variety of guests, including Chef Aarón Sánchez, actress and New York Times best-selling author La La Anthony, and Emmy winning actor, author, and producer Dan Bucatinsky. The series will focus on the impact of PsO on individuals and will be mixed with humor, personal stories and inspirational messages for the PsO community.
“Over the last five years, I’ve been sharing my story to inspire people with psoriasis to speak up and celebrate their everyday successes,” says Ms. Lauper in a news release. “With PsO in the Know, I’m excited to now bring even more patients together in a new, exciting platform to share their experiences about the realities of life with psoriasis.”
The podcasts will be available for download on Apple Podcasts, Spotify, Google Podcasts, Pandora, and Stitcher.
“I’ve been an entertainer for most of my life, had my music played on radio stations all across the world, but it has always been a dream of mine to actually host my own radio show,” says Ms. Lauper. “With the PsO in the Know podcast, I can realize that dream while helping to unite the millions of Americans who have psoriasis through a message of empowerment and hope.”
ASA Honors Drs. Doris Day and Mark Lebwohl at Virtual Gala
Dermatologists Doris Day, MD and Mark Lebwohl, MD took home top awards at the American Skin Association’s (ASA) annual gala, which was held virtually this year.
Dr. Day, a clinical associate professor of dermatology at NYU Langone Medical Center, received ASA’s Excellence in Dermatology Mentorship Award for her deep involvement and dedication to mentoring the next generation of dermatologists. “I am so proud to receive this mentorship award from ASA! My many years of work with future dermatologists is very close to my heart and I am so appreciative of this recognition,” she says.
Dr. Lebwohl, the Waldman Professor and Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai, received ASA’s Distinguished Leadership Award. “I am honored to accept this leadership award from ASA and look forward to continuing work with ASA towards their vital mission,” he says.
Incyte, a global biopharmaceutical company, was awarded ASA’s Global Impact Award in Biopharmaceutical Research and Medicine. The award was accepted by Dr. Jim Lee, Group Vice President, Head of Inflammation and Autoimmunity. The company’s research and development team is exploring the potential of JAK inhibition in a number of immune-mediated dermatologic conditions with a high unmet medical need, including atopic dermatitis, vitiligo and hidradenitis suppurativa.
Pfizer, Inc. was presented with ASA’s Distinguished Corporate Leadership Award for delivering some of the most important medical innovations in history over the last 170 years. Pfizer’s award was accepted by Ehab Mahgoub, MD, MSc, Vice President of North America Medical Affairs, Inflammation & Immunology.
Take 5 with Patrick Burnett, MD, Arcutis Biotherapeutics
Arcutis Biotherapeutics, a Phase 3 biotech developing topical therapies for common skin diseases, is on the move. Patrick Burnett, MD, PhD, Arcutis Biotherapeutics’ Chief Medical Officer, spoke to Practical Dermatology® about what we can expect from this company in the coming months and years and what this may mean for the millions of people who live with plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis including an update on topical roflumilast, their lead product candidate, which has been called a “game changer’ by at least one key opinion leader.
“We raised $159 million by offering 9.4 million shares at $17, the high end of the range of $15 to $17 in January 2020. The company offered 1.6 million more shares than anticipated. The IPO cash will go toward advancing clinical development of our experimental dermatological products.”
“The pipeline is really going to change the dermatology field. We now have four novel immune-dermatology products for multiple indications that are all moving very quickly toward patients. The indications are plaque psoriasis, atopic dermatitis, seborrheic dermatitis, scalp psoriasis, hand eczema, vitiligo, and alopecia areata.
Our lead product candidate, topical roflumilast, has just completed enrollment in the Phase 3 trials and will read out in the first quarter of 2021. The Phase 2b trial showed significant improvements in patients with plaque psoriasis in as early as two weeks. Coming right after psoriasis, I am excited that we recently announced our atopic dermatitis program will advance into Phase 3 studies after an End of Phase 2 meeting with the FDA. These trials are expected to begin at the end of 2020 or early 2021.” (Read more about roflumilast on p. 28.)
Biologically Validated Targets
“Arcutis was founded on the concept of taking best in class differentiated therapies against biologically validated targets that have a high success rate and moving these very quickly to bedside.”
“We definitely see additional unmet needs. For example, hand eczema can impact the ability to work and hamper social interactions, but there hasn’t been a lot of drug development in the hand eczema field. The choice to develop a topical JAK inhibitor for hand eczema is a smart one. There is a limited body surface area, but the disease really impacts quality of life. This is a very good fit between disease and molecule. Seborrheic dermatitis is another under-treated condition. It affects more than six million patients, without a substantial advance in treatment options for two decades. Most patients with seborrheic dermatitis have it on their scalp and face, which can be areas that are difficult to treat with most available formulations. Our unique foam formulation allows for use on all body parts, including hair-bearing areas. We are excited to be studying topical Roflumilast foam in a Phase 2 study in these patients where there is such a large unmet need.”
Innovation in the Topical Space
“The use of topical medications has been limited by efficacy and tolerability. Often times a patient gets started on a topical and has a skin reaction or they aren’t getting good enough results and don’t continue long-term even though these diseases are chronic. Our goal is to give them something that works well that they can feel comfortable using for a long period of time. The importance of topical therapy even with all the innovation can’t be overstated. There are a lot of great biologics and systemic medications out there, but even in psoriasis, 90 percent of patients are using topical therapies to treat their disease. This represents a large group of patients who may not be able to access biologic therapies in psoriasis.”
Rafael Sierra, PhD is back at Cynosure. The former Chief Technology Officer is now an R&D Advisor.
“Dr. Sierra’s passion for the science behind medical aesthetics and inherent knowledge of its clinical application are unparalleled,” says Todd Tillemans, Chief Executive Officer of Cynosure, in a news release. “The expert products Cynosure developed under his previous tenure catapulted the company from $25 million in annual sales to over $430 million, so with him returning as a senior advisor to support our outstanding research and development team, there will be no limit to our patient-focused, science-led, results-driven innovations.”
Prior to his 20-year tenure as Cynosure’s Chief Technology Officer, Dr. Sierra served as the director of laser technology for Candela’s Laser Technology Division and led both laser development and clinical application. He is also the inventor and co-inventor of over thirty US and international patents related to laser design, the use of lasers in medicine and the measurement of cholesterol.
Anne Gates, former President at MGA Entertainment and Executive Vice President and CFO of The Walt Disney Company’s Consumer Products Division, has also joined Cynosure’s board of directors and will chair the company’s audit committee.