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MARCH 2018    A Monthly Review of Articles of Interest for the Clinical Community

<This Month's Clinical Focus:  DERMATOLOGY>

 

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Realm Therapeutics Provides Clinical Results from Ph 2 Study of Atopic Dermatitis


Enrollment for its Phase 2 Atopic Dermatitis study of PR022, a topical gel, is on track and expects top-line results in Q3 2018

 

The Company's pre-clinical development program in Acne Vulgaris is also advancing well. Following preliminary discussions with the US Food and Drug Administration, the Company intends to file an Investigational New Drug (IND) application to study RLM023 in Acne Vulgaris in early Q4 2018.
 

Skin Treatment acne-1606765_1920 by KMichaela PixaBay FREE LIC CC0

Realm reports that its Phase 2 study of PR013, a topical ophthalmic solution for the treatment of Allergic Conjunctivitis, did not demonstrate efficacy. As a result, Realm has decided to discontinue further development of this program. (Due to different immunologic pathways Atopic Dermatitis is not related to Allergic Conjunctivitis.)

"While the PR013 results are disappointing, we are extremely pleased with the progress we are making with our dermatology programs, as they continue to be our top priority," said Alex Martin, Chief Executive Officer of Realm. "Atopic Dermatitis and Acne Vulgaris have different immunologic pathologies and are otherwise unrelated to Allergic Conjunctivitis. We remain confident in our technology's potential to deliver immunomodulatory and anti-inflammatory benefits, and continue to believe that it has potential for application in multiple disease areas."

For more information on Realm Therapeutics please visit www.realmtx.com.


SOURCE: Displayed with permission from PRNewswire
 


New Positive Late-Breaking Data from Two Phase 3 Psoriasis Trials of Risankizumab

 

Presented at the 2018 American Academy of Dermatology Annual Meeting

 

AbbVie presented new positive results from the pivotal Phase 3 ultIMMa-1 and ultIMMa-2 replicate clinical trials that evaluated the safety and efficacy of risankizumab (150 mg) compared to placebo or ustekinumab (45 or 90 mg, based on patient weight). These results were featured during the "Late-breaking Research: Clinical Trials" session at the 2018 American Academy of Dermatology Annual Meeting in San Diego.
 

Skin Care Trtmt pulse-818378_1920 by backy3723 PixaBay FREE LIC CC0 2


Risankizumab is an investigational interleukin-23 (IL-23) inhibitor being evaluated for the treatment of patients with moderate to severe plaque psoriasis. Risankizumab is not approved by regulatory authorities and its safety and efficacy have not been established.


- At week 16, 37 and 51 percent of patients with plaque psoriasis treated with risankizumab achieved clear skin (sPGA 0) compared to STELARA® (ustekinumab) (14 and 25 percent)

- At one year (52 weeks), 58 and 60 percent of patients with plaque psoriasis treated with risankizumab achieved clear skin (sPGA 0) compared to STELARA® (ustekinumab) (21 and 30 percent)

- Risankizumab is an investigational compound designed to selectively inhibit IL-23 and is being evaluated for the potential to deliver long-term skin clearance for psoriasis patients with 12 week dosing. Safety profile of risankizumab was consistent with previously reported Phase 3 studies

In addition, through one year of treatment, significantly more patients receiving risankizumab self-reported a Dermatology Life Quality Index (DLQI) score of 0 or 1 compared with ustekinumab. DLQI is a measure of a patient's health-related quality of life, ranging from 0 to 30, with lower scores indicating the disease has less impact on life quality.

About the Phase 3 ultIMMa-1 and ultIMMa-2 studies
ultIMMa-1 and ultIMMa-2 are replicate Phase 3, randomized, double-blind, double-dummy, placebo- and active-controlled studies designed to evaluate the safety and efficacy of risankizumab compared to placebo or ustekinumab in adult patients with moderate to severe chronic plaque psoriasis. Risankizumab (150 mg) was given as a subcutaneous injection at week 0, 4, 16, 28, 40. Ustekinumab 45 mg or 90 mg, based on screening weight, was delivered as a subcutaneous injection at week 0, 4, 16, 28, 40. The active comparator used for these studies was sourced from the European Union. The co-primary endpoints were achievement of at least a 90 percent improvement in the PASI score (PASI 90) at week 16 and achievement of a sPGA score of clear or almost clear (0/1) at week 16 compared to placebo. Key secondary endpoints at week 16 included PASI 90, sPGA score of clear (sPGA 0), sPGA score of clear or almost clear (0/1) and DLQI score of 0/1, compared to ustekinumab. Key secondary endpoints at week 52 included PASI 90, PASI 100 and sPGA 0 compared to ustekinumab. These Phase 3 studies have been conducted in cooperation between AbbVie and Boehringer Ingelheim. More information on these trials can be found at www.clinicaltrials.gov  (ultIMMa-1: NCT02684370; ultIMMa-2: NCT02684357).

"Not only do these data show significant rates of clear skin, but because we know the burden of psoriasis extends beyond the skin, we are encouraged by the patient-reported improvement in quality of life after one year of treatment," said Kenneth B. Gordon, M.D., professor and chair of the Department of Dermatology at the Medical College of Wisconsin, dermatologist at the Froedtert & the Medical College of Wisconsin Froedtert Hospital and principal investigator of the ultIMMa-1 study. "Given the significant impact of psoriasis, it is important to continue to investigate additional treatment options."


SOURCE: Displayed with permission from PR Newswire
 


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