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Superior for skin?
May 2015
by Zack Anchors  |  Email the author
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SAN FRANCISCO—A wide range of medicines are available today to treat psoriasis, but studies have shown that many patients who suffer from the condition are unhappy with their current treatment. This dissatisfaction has created an opening for new, more effective drugs that a number of pharmaceutical companies are working to develop.
 
The newly released findings of a Phase 2 study suggest that a biologic compound developed by Boehringer Ingelheim may be among the most promising of this crop of drugs aimed at raising the quality of psoriasis care. In a head-to-head comparison with a commercially available biologic, ustekinumab (Stelara), Boehringer Ingelheim’s BI 655066 was superior at clearing skin of the red, scaly patches that characterize psoriasis.
 
“There is a real need for newer, better therapies that provide patients better control of their condition,” Peter Piliero, vice president of clinical development and medical affairs at Boehringer Ingelheim, tells DDNews.”We are excited that the success of our Phase 2 study suggests that BI 655066 may have the potential to lead to a treatment that significantly improves the lives of patients with psoriasis.”
 
Psoriasis is a chronic immune-mediated disease that occurs when an individual’s immune system mistakenly attacks and inflames healthy body tissue. Roughly 125 million people throughout the world suffer from psoriasis and up to 7.5 million in the United States, according to the American Academy of Dermatology. Topical medicines are often effective against mild to moderate psoriasis, but oral and injected medicines that affect the immune system are often prescribed for more severe cases. Biologics such as ustekinumab are among the most commonly prescribed of these systematic treatments.
 
Boehringer Ingelheim’s Phase 2 study involved 166 patients who were randomly assigned to either one of three dose groups of BI 655066 or to one of two recommended doses of Stelara. All study treatments were given as an injection under the skin.
 
The comparison between the two drugs was primarily based on the number of patients in the Phase 2 study that achieved a score of 90 on the Psoriasis Area Severity Index (PASI), a commonly used metric to gauge the severity of the condition. A score of 90 is considered to reflect skin that is clear or almost clear of the symptoms of psoriasis. The study of 166 patients found that more than 77 percent of those who took BI 655066 for 12 weeks scored PASI 90, while only 40 percent of patients taking Stelara scored that high. Moreover, results showed that more than double the percentage of psoriasis patients on BI 655066 achieved completely clear skin, indicated by a score of 100, than those taking Stelara.
 
Because biologic treatments for psoriasis, including BI 655066, work by suppressing the immune system, there is some concern among researchers that these medications have the potential to leave patients vulnerable to other serious conditions ranging from deep infections to tuberculosis. However, the most commonly reported side effects in the Phase 2 trial of BI 655066 were a runny nose, sore throat and headache. “It’s still early, and we will know much more after Phase 3 studies, but at this point, safety and tolerability of BI 655066 look quite promising,” says Piliero.
 
While the exact cause of psoriasis is unknown, it is associated with an overactive immune system that drives skin cells to grow at an abnormally fast rate and accumulate to form itchy, red, flaky skin plaques. This abnormal immune response is driven by immune cells and proteins that are released, known as cytokines. BI 655066 has been specifically designed to target a specific cytokine called interleukin-23 (IL-23), which is one of the key drivers of psoriasis. “This mechanism of action is one of the main qualities that make BI 655066 different than other treatments for psoriasis,” says Piliero. “Blocking IL-23 selectively has the potential to make a big impact.”
 
There is much evidence suggesting that currently available treatments for psoriasis are not adequate for many patients. A study published in Dermatology in 2013, for example, found that 52.3 percent of patients with psoriasis were dissatisfied with their current treatment.
 
“Despite the fact that we have what appears to be an abundance of therapies to treat psoriasis, we do need more because not all therapies work for every patient and not all therapies work forever,” Dr. K. Alexander Papp, president of Probity Medical Research and lead investigator on the study, tells DDNews. “And there’s also the comorbidities that many of these patients suffer, which often make the selection of appropriate therapies challenging. A new therapy that adds to the basket of opportunities available can really increase the chance that patients will get the best, optimal care possible.”
 
Boehringer Ingelheim is currently in the process of recruiting patients for a Phase 3 study that it hopes will confirm the findings of the Phase 2 trial. The company is also pursuing Phase 2 studies to investigate the potential for BI 655066 to be used to treat spondyloarthritis and Crohn’s disease.
 
Code: E051518

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