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PR release on mid-stage eczema drug trial suggests benefit but doesn’t quantify

FAIRFIELD, N.J., May 23, 2016 /PRNewswire/ —

  • Medimetriks, in collaboration with Otsuka, announces the successful completion of a Phase 2 trial of MM36 (previously known as OPA-15406) in Atopic Dermatitis (AD)
  • MM36 is a topical phosphodiesterase 4 (PDE4) inhibitor under development for the treatment of AD
  • Results showed a therapeutic benefit as measured by percentage change in EASI score and improvement in IGA score
  • MM36 is expected to be the 2nd topical PDE4 inhibitor available in the US and may offer unique benefits for patients suffering from AD

Medimetriks Pharmaceuticals, Inc. today announces the publication of Phase 2 results for MM36 (previously referred to as OPA-15406), a novel topical non-steroidal phosphodiesterase IV (PDE4) inhibitor for the treatment of mild-to-moderate atopic dermatitis.

The successful results of the Phase 2 trial of MM36 have been published by the Journal of the American Academy of Dermatology (JAAD), the leading peer-reviewed journal in dermatology. The randomized, double-blind, vehicle-controlled study in 121 patients showed that MM36 demonstrates a statistically significant effect on the primary endpoints versus vehicle as measured by improvement in IGA score (Investigators Global Assessment) and percentage change in EASI score (Eczema Area and Severity Index).  The mean percentage improvement in baseline EASI score was notable very early at week 1 (31.4% vs. 6% for vehicle; p=.0005) and at week 2 (39.0% vs. 3% for vehicle; p=.0001).  These effects were sustained through week 8 of the study.  MM36 was also associated with improvement in patient-reported outcomes, most notably rapid and sustained itch relief, with Visual Analog Scale scores showing improvement from moderate to mild within the first week (36.4% mean change; p=.0011).

MM36, a PDE4 inhibitor, reduces inflammation in affected skin by inhibiting production of cytokines and chemical mediators that are believed to cause the signs and symptoms of atopic dermatitis. In particular, MM36 exhibits highly selective inhibitory activity against PDE4 subtype B, an enzyme that may play a significant role in inflammation. MM36 is expected to be the 2nd topical PDE4 inhibitor in the market after the potential approval of Anacor Pharmaceuticals’ crisaborole product.

“The results of the Phase 2 study suggest that MM36 represents a potentially safe, effective and well-tolerated non-steroidal treatment for mild-to-moderate atopic dermatitis,” said Linda Stein Gold, MD, director of clinical research, Department of Dermatology at Henry Ford Hospital and co-author of the article.  “Based on the results of this study, it appears that MM36 could address an important unmet need in dermatology.”

“We are pleased that JAAD, the most respected peer-reviewed journal in dermatology, published the Phase 2 results,” said Bradley Glassman, Chairman and Chief Executive Officer of Medimetriks.  “We believe these Phase 2 results demonstrate compelling evidence of MM36’s capacity to be a leading topical PDE4 inhibitor and are aggressively developing MM36 for atopic dermatitis in the US. Atopic dermatitis treatment

The JAAD article discussing the Phase 2 results can be found by visiting www.jaad.org.

About Atopic Dermatitis

Atopic dermatitis (AD) is a chronic inflammatory skin condition characterized by red, swollen and cracked skin with intense itching.  The onset of AD occurs most commonly between 3 and 6 months of age, with approximately 60% of patients developing the condition in the first year of life and 90% by 5 years of age. The majority of affected individuals have resolution of disease during childhood, although 10% to 30% of patients maintain the condition throughout their lives.  A small percentage of the population develops first symptoms as adults. It has been estimated that approximately 18 million people are living with AD in the U.S. and this disease accounts for up to 20% of patient visits to dermatology offices.

Current treatments for atopic dermatitis include topical corticosteroids and topical calcineurin inhibitors.  Topical steroids are typically used as first line therapies and are effective anti-inflammatory agents.  However, topical steroids may be associated with local and systemic side effects when used for extended periods of time, including skin atrophy, acne and telangiectasias locally, and HPA axis suppression systemically.  Topical calcineurin inhibitors (TCIs) are recommended as second-line treatment for people with atopic dermatitis who are at risk of steroid-related side effects. TCIs carry boxed warnings about a possible association with skin malignancies and lymphoma, although studies have not demonstrated a clear link.  Their use can be limited by local adverse reactions such as burning and stinging.

About MM36
Medimetriks has sole, exclusive US rights to MM36.  Discovered by Otsuka, MM36 is an investigational non-steroidal topical anti-inflammatory PDE-4 inhibitor in development for the potential treatment of atopic dermatitis. MM36 is hypothesized to exert anti-inflammatory action by inhibiting the production of cytokines and chemical mediators thought to cause the signs and symptoms of atopic dermatitis. In particular, MM36 exhibits highly selective inhibitory activity against PDE4 subtype B, which is an enzyme that may play a significant role in inflammation.

About Otsuka

Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka Pharmaceutical, which employs approximately  31,000 people worldwide, is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group that is headquartered in Tokyo, Japan. The Otsuka Group has business operations in 28 countries and regions around the world, with consolidated sales of approximately USD 11.9 billion in fiscal year 2015. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en.

About Medimetriks
Medimetriks Pharmaceuticals, Inc. is a leading independent branded Dermatology company focused on the development, licensing and commercialization of innovative prescription skincare brands. The Company is dedicated to addressing unmet physician and patient needs with unique therapies that advance patient care.

For more information, please visit: www.medimetriks.com

Media Contact:

David Addis
Senior Vice President, Brand Communication                                                             
Medimetriks Pharmaceuticals, Inc.
daddis@medimetriks.com
+1 973 882 7512, extension 569

SOURCE Medimetriks Pharmaceuticals, Inc.

Related Links

http://www.medimetriks.com

Medimetriks announces the results of a successful Phase 2 trial of MM36 in Atopic Dermatitis; Study results and design published in the Journal of the American Academy of Dermatology (JAAD)

Our Review Summary

eczemaThis news release describes the results of a somewhat small (121 patients) phase 2 safety and efficacy trial of a topical non-steroidal treatment for mild-to-moderate symptoms of eczema (atopic dermatitis). The release is based on a study published in the Journal of the American Academy of Dermatology, and offers substantial detail about the company (Medimetriks) which owns the U.S. rights to the experimental treatment, dubbed MM36. The MM36 compound is a non-steroidal anti-inflammatory ointment believed to stop itching and redness by blocking chemicals released by an enzyme known as PDE4 subtype B and active in causing inflammation. The release describes the percentage of improvement in symptoms over a period of eight weeks, but doesn’t describe or quantify what improvement means. And it highlights several alternative treatments, but offers no data on how MM36 compares with these existing therapies. Readers will learn little to nothing about the makeup of the test group, side effects, or costs.

A WSJ story on this eczema study, which was also reviewed by HealthNewsReview.org, shared an excessive optimism with respect to approval and availability of this treatment still in development.

 

Why This Matters

As the release notes with admirable detail, atopic dermatitis — and the “red, swollen and cracked skin” that accompanies the “intense” itching associated with it — is estimated to strike 18 million people in the U.S. alone. Moreover, current therapies, such as corticosteroids, cause unwanted side effects when used over long periods of time, and some burning and stinging. Most people who have experienced eczema would agree that while not life-threatening, the symptoms are sometimes disfiguring and can be extremely unpleasant. A treatment that targets a particular enzymatic pathway without the potential downsides of current therapies would thus be welcome. And because these conditions are often chronic, the markets for such products can be highly profitable.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The release discloses the total 2015 sales of Otsuka, the drug maker, but offers not a penny’s worth of information about the costs of current therapies or whether the new product would be more or less expensive. Although there is no pricing for an investigational new drug still in clinical trials and not yet FDA-approved for sale, it would be helpful to consumers to know if part of the novelty of the product will be its availability and cost.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

Although the release does give the mean percentage improvement scores compared to baseline measures and patient-reported outcomes (39% improvement for those volunteers assigned the MM36 compound compared to 3% on the placebo at week 2 and throughout the remainder of the 8-week study), it could have been greatly improved by saying specifically how many of the 121 experienced what percentage of improvement. There also is no information on what it actually means to say a condition has improved from “moderate” to “mild,” especially given that the treatment is being tested only for those with “moderate to mild” eczema. According to the published study, the number needed to treat (NNT, or the number of patients that need to be treated for one to benefit compared with a control in a clinical trial) was about 6 for an improvement of at least 2 levels on a 0 – 5 scoring system. According to that measure, the difference in improvement between the high dose cream and the placebo was about 18%.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The published research report clearly reports that some subjects experienced a worsening of symptoms, or no real change, but the release fails to mention any data on side effects. According to the study, the harms were about the same in the high dose group and the placebo, but were greater in the low dose group (and that difference was statistically significant).

Does the news release seem to grasp the quality of the evidence?

Satisfactory

The release doesn’t give the study methods in strong detail, but it does describe it as a double blind, randomized clinical and placebo control trial, which suggests a high level of evidence. The published study appears to show a low risk of bias. The study also showed there was a dose response between the high, low and control doses for the primary outcome event (degree of improvement) and except for some discrepancies in the adverse events rates (higher in the low dose group than in the high dose or placebo groups) there was fairly good precision and the NNT of 6 is not unreasonable. It would have been beneficial to readers if the release had included some information about the age, gender and race of those being treated, as well as more details about the patient-reported improvements.

Does the news release commit disease-mongering?

Satisfactory

The release doesn’t engage in disease-mongering. The release mentions a possible link to skin or blood cancer with the use of topical steroids which are in wide use today, but then notes that the studies suggesting the link have not proven the case.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

The release doesn’t include any information about how the study was funded. The study itself discloses that several authors are paid consultants for the companies making the drug.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The release does give ample information about alternative treatments, including the standard treatments. We’d still like to know how the drug under development would be an improvement over alternative treatments, including some of the over-the-counter treatments available for patients with mild eczema. How much better would the new treatment be in terms of symptomatic relief? Also, there is no mention of the fact that there are other PDE4 inhibitors already under development and on the market for other inflammatory conditions.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

Although industry-sponsored releases must avoid “forward looking” predictions about future drug approval, the release would have added useful information if it had noted whether this phase 2 trial would be followed by phase 3 trials. As it stands there is no way to gauge if or when this product will be available.

It seems overly optimistic to make this statement based on a phase 2 study: “MM36 is expected to be the 2nd topical PDE4 inhibitor available in the US and may offer unique benefits for patients suffering from AD.”

Does the news release establish the true novelty of the approach?

Satisfactory

The release notes in two places that MM36 would be the second topical PDE4 inhibitor after a competing product (cisaborole, manufactured by Anacor Phamaceuticals). Cisaborole is further along in the approval-seeking process than MM36.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

The news release does not employ unjustifiable language.

Total Score: 5 of 10 Satisfactory

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