Insights

Read more about Aclaris and our vision for tackling “white spaces” in dermatology,
and beyond in our company blog.

Sort by:

At Aclaris, we have built a sharp, experienced research and development team and have resources to tackle some of the “white spaces” in dermatology – conditions that lack approved medications or where significant treatment gaps exist. In our discovery laboratories in St. Louis and our clinical research unit in Wayne, PA, we are mining new insights into biologic pathways to develop innovative medicines that could potentially treat intractable conditions in dermatology and immunology.

But one company alone cannot ensure a vibrant ecosystem for innovation in dermatology. The future of dermatology depends on many physicians, researchers, business leaders and companies attacking disease targets from multiple angles.

That is why I joined a group of about a dozen other dermatologists, researchers, and business leaders seven years ago to form a novel non-profit organization committed to fostering and driving innovation in dermatology. At the time, each of us had individually concluded that there remained a significant need for scientifically-driven innovation to address the many dermatologic conditions that continued to vex researchers, frustrate physicians, and cause patients both physical and emotional discomfort.

To be sure, the number of new dermatology medicines submitted to the FDA for approval has fallen steadily over the past few decades. New medicines have been introduced for conditions like melanoma and plaque psoriasis, but dermatology is a field characterized by many common skin conditions as well as rare genetic disorders where significant unmet needs remain.

With the leadership of William Ju, M.D. as president, these colleagues and I founded Advancing Innovation in Dermatology (AID). We were hoping to create a resource and serve as a connection for scientists, clinicians, and entrepreneurs dedicated to expanding treatment options in the field. Now, AID has become the community of innovators that we envisioned, and that was so needed in our field.

Earlier this year, we held our fifth annual “Dermatology Summit,” and our fourth annual “Dermatology Entrepreneurship Conference”. We were heartened by the growing numbers of attendees each meeting attracted. Hundreds of people enthusiastic about innovation gathered to network and learned from experts in the field. The program covered everything from the latest advances in aesthetic dermatology to clinical trial management to outcomes measurement.

Just as we want to drive and support entrepreneurship, we also understand that we need to nurture the next generation of innovators committed to dermatology. Investing in future breakthroughs has to begin now, by training and inspiring new leaders to develop products and ultimately commercialize them. Right now, AID is in the process of reviewing applications from dermatology residents and fellows as well as early-career researchers and clinicians for a 10-month AID-sponsored program. The half dozen scholars selected for the program will connect with innovators from AID-member companies who can provide real-world guidance on how to advance new dermatologic treatment options, such as defining an opportunity, creating a drug development plan, and accessing expertise to navigate the regulatory approval process.

AID recognizes that insufficient financial resources can be a significant roadblock to innovation, especially in the high-risk early stages of proof-of-concept development. We have created the AID Accelerator Fund which is directed to bridge the gap between academic institutional funding and traditional venture capital. The fund provides seed funding and in-kind business support, such as guidance on establishing and protecting intellectual property. The fund is described in an article titled “Catalyzing Future Drug, Device, and Information Technology Breakthroughs in Dermatology” which appears online in the April 11 issue of JAMA Dermatology.

Beyond our work at Aclaris to drive dermatologic innovation, I am proud to have played a role in AID. If you are interested in learning more about it, visit www.advancing-derm.com.

When I treated patients in my dermatology practice, I saw people struggle with skin conditions that were not life-threatening, yet took an emotional toll. These people included patients with psoriasis who refrained from intimate relationships because of their skin plaques; patients with rosacea who worried that their colleagues would think they had been drinking; patients with alopecia areata who felt compelled to wear hats or wigs; and patients with vitiligo who minimized their time in public places to avoid strangers’ questions and stares.

Dermatologists know these stories are common. Take alopecia areata and vitiligo, for instance. Alopecia areata is an autoimmune skin disease that results in partial or complete loss of hair on the scalp and body, and about 6.8 million Americans have or will develop alopecia areata during their lifetimes.[i] Vitiligo is an autoimmune disease in which the skin loses its pigment; it is the most common pigment disorder worldwide.[ii],[iii] Despite this prevalence and patients’ need for treatment, there is a gap – or white space – in the availability of safe and effective medications.

What can be done to improve patient access to treatments? Earlier this year, I was invited to address this issue of innovation and access at the Winter Clinical Dermatology Conference, a continuing medical education conference for dermatologists.

In my opinion, the first step to overcoming barriers to patient access is bringing new safe and effective medications to market. In response to the low priority that the pharmaceutical industry has placed on developing treatments for skin conditions, Aclaris focuses on discovering and developing compounds that could become therapies for conditions that fall into the white space of dermatology and immunodermatology. We have expertise in identifying promising work from research labs – like the early scientific work on Janus kinase (JAK) inhibitors conducted at Columbia University – and then translating this work into the clinic. Right now, we are conducting clinical trials with multiple JAK inhibitor compounds for the treatment of alopecia areata and vitiligo – with the hope that one day we may have new medicines that will benefit millions of patients worldwide.

Unfortunately, even when treatments are available, too many interests interfere with the physician-patient relationship and limit patients’ access to care. My perspective is that the issue is three-fold, involving third-party payers, chain drug stores and patients.

Third-party payers have extraordinary power to limit coverage for branded medicines and shift a large percentage of the cost of treatment to patients and their employers. Payers often do provide better coverage and reimbursement for the first FDA-approved medication for a disease, so our strategy of focusing on the white spaces may help avoid reimbursement headwinds. Additionally, the business practices of chain drug stores sometimes add to the cost burden for patients, even for generic drugs. In some cases, generics are priced at 80 percent of the brand. And with increasing consolidation in that industry, patients have been left with very few alternatives. It will be interesting to see how the entry of Amazon as a new competitor affects the landscape.

That brings me to patients. I believe that some of the responsibility for access to treatment falls on patients themselves. Patients don’t always realize that when they prioritize convenience – say by seeking care for a skin condition at an urgent care facility or a clinic in a pharmacy – they may be sacrificing a good outcome that would have been accessible through the expertise of a board-certified dermatologist. Also, patients who see dermatologists should understand that not every treatment can be submitted to their insurance. They must keep in mind that they have to pay out-of-pocket for treatments whose sole purpose is to improve appearance, such as the removal of asymptomatic benign lesions like seborrheic keratoses (SKs).

Scientific innovation and openness to change are fundamental to the culture of Aclaris. We are committed to identifying, developing and commercializing therapies to address the white spaces in aesthetic and medical dermatology and immunodermatology. I’m confident we can do our part to increase patient access to transformative medicines.



[i] National Alopecia Areata Foundation. FAQ's. Available at: https://www.naaf.org/faqs. Retrieved May 30, 2017.

[ii] Boniface K, et al. New Insights Into Immune Mechanisms of Vitiligo. G Ital Dermatol Venereol. 2016 Feb;151(1):44-54. Epub 2015 Oct 29. Available at: http://www.ncbi.nlm.nih.gov/pubmed/26512930.

[iii] American Vitiligo Research Foundation. Fitzpatrick T., et al. Vitiligo Facts. Available at: http://www.avrf.org/facts/viti...

Oct 03, 2017 | Focus on Patients

Skin, the largest organ of the human body,[1] plays a critical role in the immune system, providing a physical barrier against foreign substances and acting as an immunologic organ.[2] Human skin contains an estimated 20 billion T cells – a white blood cell that is an important part of the body’s immune response – far greater than the number of T cells found circulating in blood.[3]

Unfortunately, despite the amazing efficiency and precision with which the skin and immune systems work together, things sometimes do go wrong. These “errors” can lead to autoimmune dermatological disorders such as a type of hair loss known as alopecia areata, and other conditions including eczema, psoriasis and vitiligo.

As our understanding of the immune systems grows, one of the most exciting areas of dermatology research is the development of highly targeted immuno-therapeutics that have the potential to change approaches to managing skin disorders. Aclaris Therapeutics is working in this cutting-edge field of immunodermatology, working with several families of immunomodulators targeting Janus kinase (JAK), interleukin-2 inducible kinase (ITK) or the p38/MK2 pathway. These intracellular signaling pathways are involved with many aspects of the body’s immune responses, including skin inflammation.[4]

The first of the four JAK enzymes was discovered in the early 1990s by researchers at the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Subsequent studies showed that genetic defects in a particular JAK, JAK3, can cause severe combined immunodeficiency (SCID).[5] In fact, many of you may be familiar with the medical case of David Vetter, dubbed “the bubble boy,” who suffered from SCID. It was his case that ultimately led to the discovery of JAK and spawned the idea that drugs blocking these proteins might be protective against the damaging inflammation of certain autoimmune diseases.[6]

At Aclaris, we are diligently working on oral and topical JAK inhibitor candidates, which are in clinical testing for conditions including alopecia areata. Our research and development team also is actively looking at the application of JAK inhibitors for the potential treatment of androgenetic alopecia, also known as male/female pattern baldness.

We find the potential for immunodermatology so promising that we recently acquired Confluence Life Sciences, Inc., a company focused on discovery of new kinase inhibitors. The Confluence acquisition expands our anti-inflammation and immunology pipeline. Confluence has developed a family of complementary JAK inhibitors, including unique, skin-targeted JAK1/3 inhibitors that we will evaluate for the potential treatment of alopecia areata and, possibly, other skin disorders. These skin-targeted, “soft” JAK inhibitors are designed to be active in the skin but rapidly metabolized in the circulation.

ITK inhibitors, a second category of kinase inhibitors was acquired by us as part of the acquisition of Confluence. This kinase is involved with T cell signaling, and it has a particularly potent influence on Th17 cells and their expression of interleukin-17. We have plans to evaluate ITK inhibitors in psoriasis and related pathologies.

A third drug class that has come to Aclaris via Confluence is called p38/MK2 pathway inhibitors. One can think of these drugs as “oral anti-TNFα and anti-IL1β” agents. P38/MK2 is the central pathway involved in all chronic inflammation.

Finally, with the Confluence acquisition, we not only expanded our inflammation and immunology pipeline, but also gained a drug discovery engine led by some of the leading researchers in the field.

As a dermatologist-led biopharmaceutical company focused on identifying, developing and commercializing innovative and differentiated therapies to address significant unmet needs in medical and aesthetic dermatology, we are proud to be on the front lines of immunodermatology.


[1] Swann, G. Editorial. Journal of Visual Communication in Medicine. 2010; 4:148-149
[2] Salmon JK, Armstrong CA, Ansel JC. The skin as an immune organ. Western Journal of Medicine. 1994;160(2):146-152.
[3] Seneschal J, Clark RA, Gehad A, Baecher-Allan CM, Kupper TS. Human Epidermal Langerhans Cells Maintain Immune Homeostasis in Skin by Activating Skin Resident Regulatory T Cells. Immunity. 2012;36(5):873-884. doi:10.1016/j.immuni.2012.03.018.
[4] Schwartz DM, Bonelli M, Gadina M, O’Shea JJ. Type I/II cytokines, JAKs, and new strategies for treating autoimmune diseases. Nature Reviews Rheumatology. 2016;12(1):25-36. doi:10.1038/nrrheum.2015.167.
[5] Notarangelo LD, Mella P, Jones A, de Saint Basile G, Savoldi G, Cranston T, Vihinen M, Schumacher RF. Mutations in severe combined immune deficiency (SCID) due to JAK3 deficiency. Hum Mutat. 2001 Oct;18(4):255-63.
[6] Cossu F. Genetics of SCID. Italian Journal of Pediatrics. 2010;36:76. doi:10.1186/1824-7288-36-76.

Aclaris Therapeutics is a biopharmaceutical company founded by dermatologists and dedicated exclusively to dermatology. As one of those founders and President and Chief Executive Officer of Aclaris, I’m privileged to lead a team that is committed to developing and commercializing innovative medical and aesthetic treatments for dermatologic conditions. We are focused on skin and hair conditions characterized by underserved patient populations in which treatment gaps exist, or no FDA-approved medications are available for patients. Dermatology patients are at the heart of everything we do, and our goal is to empower patients with choices by bringing to market new treatments with the potential to improve the way they look and feel.

Aclaris is dedicated to developing impactful medicines for the ultimate benefit of the patient. It’s what motivates our team every day. We are committed to addressing patients’ needs not only through innovation but also through a laser-like focus on our core competencies in identifying, developing, achieving regulatory approval for, and commercializing new treatments for underserved skin and hair conditions.

An example of an innovation that was born in clinical practice and developed by industry is a new topical treatment for rosacea approved by the FDA in January 2017 and marketed by Allergan plc as Rhofade™. This medicine has the potential to help millions who suffer from rosacea, a common facial skin disorder that causes many patients significant distress. Dr. Stuart D. Shanler, my fellow dermatologist and Chief Scientific Officer of Aclaris, co-invented the treatment and spent years on its development because he saw a real unmet need in the rosacea patients he cared for while practicing dermatology.

Sometimes, great advances in medicine come out of the basic science research efforts of academic centers. For example, a research team at Columbia University Medical Center led by Angela Christiano, Ph.D., identified the immune cells responsible for destroying hair follicles in people with alopecia areata, an autoimmune disease that causes hair loss. These researchers then tested a drug in the family of Janus Kinase (JAK) inhibitors approved by the FDA for another disease and found it eliminated these immune cells and restored hair growth in a small number of patients. Aclaris licensed the intellectual property from Columbia University to develop medicines for patients with alopecia areata and other dermatological conditions who currently have no satisfactory treatment options.

Identifying new approaches to serving dermatology patients was the reason I decided to switch to the industry side of health care. I realized my impact could be greater than the fulfilling work I was engaged in as a practicing dermatologist. At Aclaris, offering new options to people suffering from dermatologic conditions is always on our minds, hence our dedication to Illuminating Science, Empowering Patients.