Summary
Here is our December – March quarter review of clinical research news in eczema treatment. We wanted to provide you with an easy source for understanding the latest in eczema research, so we’ve reviewed the news and put it into short blurbs with links provided.
First quarter of 2024 was a very promising time for eczema clinical studies. Several unique treatments are being developed and showing great results. Some of the benefits we are looking at through this quarter include:
- Longer dosing frequencies. Moving away from 2-4 weeks into 8 weeks and beyond.
- Greater efficacy of treatments.
- More options to target different causes of eczema, which will expand the number of patients who see successful treatment.
- Non-steroidal topical solutions that work in new and exciting ways.
- Focus on studying darker skin tones with eczema.
**Dec 1st, 2023**
Novel Subcutaneous Biologics Show Promise in Atopic Dermatitis
In two early stage trials, “TREK-AD” and “STEAM-AD” both biologics showed “clinically meaningful” results without raising any safety concerns. In TREK-AD results were relatively quick with progression happening within the first two weeks of treatment. Tiago R. Matos, MD, PhD, MSc is quoted, “As we gain more detailed understanding of the mechanisms behind each disease, novel treatments evaluate if increased specificity can lead to higher improvement of symptoms with less side effects.”
– [Link]
**Dec 5, 2023**
Technoderma concludes Phase I trial of atopic dermatitis drug
A chinese biopharmaceutical company concluded phase 1 testing of TDM180195, a new topical ointment for the treatment of atopic dermatitis with positive safety results. It is reported that there was negligible to no systemic exposure. This means the ointment is fairly well targeted and will have less of a whole body effect. No comment on the efficacy of the treatment but there will likely be statements in later trials.
– [Link]
**Dec 8, 2023**
Kymera’s protein degrader starts Phase II trial in atopic dermatitis
Phase II clinical trials of Kymera Therapeutics protein degrader treatment began. In a December 7th press release they projected trials to end in the first quarter of 2025. This drug is being developed to treat inflammatory diseases.
– [Link]
**Dec 15, 2023**
FDA Approves Tralokinumab for Moderate to Severe Eczema in Adolescents
Tralokinumab was approved for use in adolescents by the FDA. It is the first treatment for adolescents that targets the interleukin-13 cytokine, offering a new option for those who’s eczema has resisted other treatments. Since everyone’s case is individual some people will respond to other treatments and some will not. This advancement in precision medicine means more people will have an option that works for them.
– [Link]
**Dec 15, 2023**
FDA Approves Historic Roflumilast Foam 0.3% For Seborrheic Dermatitis
Roflumilast (also known as Zoryve) is groundbreaking because it is non-steroidal and also is the first drug approved for seborrheic dermatitis in over 20 years with a new mechanism of action. It is also exciting because many patients have found other solutions for sensitive areas like the face or scalp to be greasy and unpleasant on the skin.
– [Link]
**Dec 18, 2023**
InnoCare’s atopic dermatitis drug hits primary endpoint in Phase II trial
Chinese biopharmaceutical company InnoCare published significant skin clearance results of its immunomodulating drug ICP-332. The safety profile was positive as well. Progress is being made.
**Dec 18, 2023**
Cara Therapeutics Discontinues Study of Oral Difelikefalin with Topical Steroids
We believe in telling the good with the bad when we report to you. We also believe that failure isn’t the end of the world. Oral Difelikefalin was found to have no clinical benefit when used alongside topical steroids, compared to just using topicals alone. Every failure is just another test we don’t need to spend effort on. On to the next!
– [Link]
**Dec 19, 2023**
Aldeyra Therapeutics’ ADX-629 Achieves Key Milestones in Atopic Dermatitis Study
In phase 2 trials of an investigational RASP modulator, “ADX-629”, the drug was shown to have effectiveness in treating atopic dermatitis. More trials are necessary to further study the drug, but this is yet another option in development right now.
– [Link]
**Jan 10, 2024**
Aclaris Therapeutics Announces Top-line Results from 4-Week Phase 2b Trial of ATI-1777 for Mild to Severe Atopic Dermatitis
In a trial of ATI-1777 formulated into an emollient containing spray, the drug showed efficacy as good as the market standard. The real benefits of this drug come in its use. It is convenient to have in a spray, and allows for just once-a-day application.
– [Link]
**Jan 12, 2024**
Dermavant maps out atopic dermatitis filing after positive Phase III data
Across three studies of Vtama cream, a non-steroidal topical treatment for eczema, the drug showed a 75% disease burden reduction in over 80% of patients. Within 24 hours of first application 77% of patients experienced a reduction in itching. Dermavant is expected to file for approval in the first quarter of 2024.
– [Link]
**Jan 16, 2024**
Allakos Skin Drug Fails 2 Mid-Stage Tests, Sparks Restructuring to Cut 50% of Staff
When testing new drugs, it has to be proven to be a certain level more effective than a placebo. The article states that there were improvements over the placebo but not enough to continue research.
– [Link]
**Feb 1, 2024**
Bio-Thera Solutions Announces Initiation of Phase IB / IIA Clinical Trial for BAT6026, a Monoclonal Antibody Targeting OX40, in Patients with Moderate to Severe Atopic Dermatitis
Following a successful phase 1 trial, more testing will begin for BAT6026 in treating eczema. Hopefully this one pans out! This drug is expected to be an effective option, but only time will tell.
– [Link]
**Feb 14, 2024**
CORRECTING and REPLACING, Galderma Announces Regulatory Filing Acceptance for Nemolizumab in Prurigo Nodularis and Atopic Dermatitis in the U.S. and EU
Galderma filed for approval of Nemolizumab with the FDA, and they have received acceptance of that filing. Clinical testing for the drug went well. More than a third of patients achieved close to or full skin clearance. More than 40% of patients saw a reduction of 75% or more in skin coverage of eczema.
– [Link]
**Feb 21, 2024**
FDA places clinical hold on RAPT Therapeutics’ zelnecirnon trials.
These trials actually began during this quarter but we waited to report on them until we got here. Due to an adverse liver failure of one of the patients the entire trial had been put on hold while the matter was further investigated. We won’t say anything until that investigation is conducted.
– [Link]
**Feb 27, 2024**
Atopic Dermatitis Clinical Trials Market to Grow at CAGR of 12.73% through 2033; Rising Incidence of Atopic Dermatitis to Propel Growth
The first paragraph puts it nicely, “Technological developments, a rise in atopic dermatitis prevalence, a developing pipeline of treatments for the condition, and more funding and investments are the factors driving the market’s expansion. Furthermore, collaborations between pharmaceutical and dermatological companies and contract research organisations promote knowledge sharing, quicken product development, and lower risk—all of which support market growth.”
Eczema is becoming more common, this itself is not great, but when taken with all the other information, the silver lining is that we are expecting a serious push towards drug development that may yield excellent solutions. On top of the other reports in this review, we are feeling positive about the future.
– [Link]
**March 5, 2024**
Apogee Announces Positive Interim Results from Phase 1 Healthy Volunteer Trial for APG777, its Novel Half-Life Extended Anti-IL-13 Antibody for the Treatment for Atopic Dermatitis and Other Inflammatory Diseases, Exceeding its Trial Objectives Ahead of Schedule with Half-Life of Approximately 75 Days
In a news release written by the company themselves, Apogee had a very positive outlook on their phase 1 data for their novel eczema drug APG777. It is a biologic that targets different pathways than anything else in this research review. This shows diversity in treatment methodologies. They are hailing the drug as potentially best in class in terms of pharmacokinetics (how the drug is distributed, metabolized, and excreted from the body). Why you ask?
Well for one, if successful APG777 would be the first of its kind that can be dosed only every 3-6 months. As opposed to 2-4 weeks, this would reduce the burden on the patient significantly. The article goes on, “In our head-to-head preclinical studies, APG777 demonstrated equivalent or better potency to lebrikizumab in the inhibition of IL-13 signaling“. Combining stronger potency, less doses, and a good safety profile would make this a significant breakthrough in eczema treatment. Let’s see what the future holds for this development.
– [Link]
**Mar 8, 2024**
Alphyn gears up for Phase IIb trial for dermatitis treatment
In the trials of zalabafin hydrogel, non-steroidal topical treatment for eczema, Alphyn reports that during Phase IIa the treatment met all of its primary goals. It showed significant reduction in itch and inflammation. This treatment targets the bacterial component of eczema.
– [Link]
**March 8, 2024**
LEO Pharma Presents New Long-Term Adbry® (tralokinumab-ldrm) Data in Adults with Moderate-to-Severe Atopic Dermatitis at the 2024 AAD Annual Meeting
New data analyzing the long term potency of Adbry for eczema has been released today. This data is part of an extended clinical trial that seeks to monitor and build understanding of the consistency and safety of the drug. The results showed that over 70% of patients saw reduction of eczema below what is considered “mild”. Overall a fairly positive report. The takeaway that we want our audience to have is the continued study of treatments. When we think something is good enough to release to the public, the medical community continues to study the treatment to understand it more!
**March 10, 2024**
Galderma @ AAD 2024: New Data Demonstrate the Long-Term Efficacy of Nemolizumab in Prurigo Nodularis and Its Durability in Atopic Dermatitis
After receiving priority review in the treatment of prurigo nodularis (P.R.), Nemolizumab has new data showing that it is effective in treating P.R. and eczema. Testing showed similar potency when dosed every 8 weeks versus every 4. With the average dose timing being every 2-4 weeks right now, this is a pretty decent report. Nearly 90% of patients had significantly reduced itching. Sleep quality was also improved.
**March 10, 2024**
More than two-thirds of people with atopic dermatitis and skin of color experienced skin improvement in a first-of-its-kind lebrikizumab study
This article is summed nicely by the words of Andrew Alexis, M.D., M.P.H., Professor of Clinical Dermatology and Vice Chair for Diversity and Inclusion in the Department of Dermatology at Weill Cornell Medicine. Quoted in the article, “”People with skin of color are disproportionately affected by atopic dermatitis, often experiencing more severe symptoms, a delay in diagnosis and a lengthier timeframe to find appropriate treatment. They also have been historically underrepresented in clinical trials, which means we have lacked data pertaining to the treatment of patients with skin of color,” he goes on, “”With these initial results, Lilly is taking a step toward investigating the needs of people with skin of color affected by atopic dermatitis.”
- “68% of people experienced significant improvement of at least 75% in disease extent and severity (EASI-75)*.
- 46% of people experienced at least 90% improvement in disease extent and severity (EASI-90)†.
- 39% of people achieved clear or almost clear skin (IGA 0,1)‡ with a reduction of at least two points from baseline.
- 56% of people experienced clinically meaningful itch relief (PNRS ≥4-point improvement)§.
No new safety signals were observed and there were no serious adverse events reported. “
– [Link]
**March 11, 2024**
ASLAN Pharmaceuticals Provides TREK-DX Study Update and Highlights Potential of Eblasakimab in Dupilumab-Experienced Atopic Dermatitis Patients
This is an interesting study. A first of it’s kind study, focusing on the efficacy of eblasakimab in patients who have already tried dupilumab, showed that the drug has potential to work when dupilumab is less effective. This highlights the fact that eczema is not a one cause disease. The data is still low in quantity, but did show promise. This is good because developing different treatment methods can open doors for more patients to achieve a better quality of life.
– [Link]
**March 11, 2024**
Sanofi’s amlitelimab shows best-in-class response in atopic dermatitis
Continuing the story of the first post in this review, during the STREAM-AD trials amlitelimab had positive results in treating eczema.
“Results from this part of the study indicate amlitelimab’s potential for durable off-drug efficacy, which means less frequent dosing every 12 weeks could be evaluated”.
“In the announcement accompanying the data, the head of global development, immunology and inflammation at Sanofi, Naimish Patel said: “It’s unprecedented to see this type of durability of clinical response, which we believe could be very meaningful to patients and is the reason why we selected an every 12-week dosing regimen in the AD pivotal programme.”
– [Link]
**March 12, 2024**
Lebrikizumab Found Effective for Patients With Eczema, Darker Skin Tones
In a recent study to evaluate lebrikizumab in people with darker skin tones, it was shown to have significant results without any safety concerns. Jill Waibel, a dermatologist in California is quoted, “”I usually tell my [patients with postinflammatory hyperpigmentation] that it takes 6 months to see improvement. In this study, we saw patients achieve improvement in skin tone in a 4-month timeframe. PIH is sometimes more distressing than a primary condition, whether it’s acne or atopic dermatitis. In this case, it was surprisingly improved with lebrikizumab”.
This is great news. As always information is tentative and it’s difficult to make a forward looking statement, but it’s good. We are seeing novel treatments developed frequently right now and they are improving the quality of care and options for many patients globally.
– [Link]
