Amgen, Lilly turn in upbeat data on rival psoriasis drugs

Posted under Amgen, Blog, Clinical Trials, Companies, Diagnostics, Eli Lilly, Funding, Medical Devices, Medical Supply, monoclonal antibody, Pharmaceuticals, Pipeline, psoriasis, R&D, Startups, Universities, Videos by rmcbride

In the hunt to develop targeted drugs against plaque psoriasis, Amgen ($AMGN) and Eli Lilly ($LLY) both said their experimental biologics met the main goals of their respective mid-stage studies. And the positive data from the studies, both reported in the prestigious New England Journal of Medicine, have helped propel Lilly's and Amgen's programs into Phase III territory.

Both companies' drugs are monoclonal antibodies that target interleukin-17, a culprit in the inflammation that occurs in diseases such as plaque psoriasis, which is a chronic skin ailment that triggers the formation of red, scaly patches on the body.

Indianapolis-based Lilly said its ixekizumab offering passed the main test of the 142-patient trial, with way more patients on the drug achieving at least a 75% improvement in their Psoriasis Area and Severity Index scores versus those in the placebo camp at week 12. The study showed that 82% of patients on the 150-mg dose, 83% on the 75-mg dose and 77% on the 25-mg dose had a 75% improvement, compared with 8% in the placebo group after 12 weeks.

Some of the most frequent adverse events in patients on Lilly's treatment included respiratory inflammation, respiratory infections, headaches and reactions at the injection site. 

In Thousand Oaks, CA-based Amgen's mid-stage trial of brodalumab in 198 patients, the study met the top goal with the drug providing an improvement in disease score for patients on all doses versus placebo. There was an average improvement of 85.9% in those who took 140-mg dose, 86.3% in patients on 210-mg dose and 45% in people on a 70-mg dose compared with 16% in the placebo group. 

The most common side effects among patients on Amgen's drug were common cold, respiratory infections and irritation around the injection site. Two cases of neutropenia were also reported in patients on the 210-mg dose of the drug.

Amgen, of course, already markets its blockbuster antibody drug Enbrel for treating psoriasis. Yet companies are pursuing more targeted treatments that could quell the side effects related to existing therapies. There's a large potential market. According to Amgen, 80% of the 125 million people who suffer from psoriasis have the plaque version of the disease.

"Treatment with antibodies targeting interleukin-17 or its receptor should be more specific and may be expected to result in fewer side effects and therefore holds promise for patients with psoriasis," wrote Ari Waisman of the Johannes-Gutenberg University of Mainz in Germany in his commentary for the NEJM, as quoted by MedPage Today.

- here's Amgen's release
- and Lilly's release
- read BusinessWeek's article
- and MedPage Today's report

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Experimental psoriasis drug beats Enbrel in study

UPDATED: Idera gets FDA green light for Phase II psoriasis drug test

Posted under Blog, Companies, Diagnostics, Funding, Idera Pharmaceuticals, IMO-3100, Medical Devices, Medical Supply, Merck KgAA, Pharmaceuticals, psoriasis, Startups, Universities, Videos by Mark Hollmer

Idera Pharmaceuticals ($IDRA) is ending the week with a second piece of positive news.

The Cambridge, MA-based drug developer disclosed Dec. 1 that the FDA has reversed a clinical hold on IMO-3100, which is designed to treat autoimmune diseases and inflammation. Based on a new study protocol, the FDA will allow it to proceed to a Phase II trial, now slated to begin during the first half of 2012.

Idera has been laying the groundwork for advancing IMO-3100 for months. The company sent the FDA an initial Phase II trial protocol back in July, which would test the novel dual-TLR antagonist in psoriasis patients over 12 weeks of treatment. The agency placed that plan on hold over various concerns. A new Phase II trial protocol submitted in October helped Idera gain the green light to proceed, with plans to test psoriasis patients over one month rather than three.

The drug is designed to block production of multiple cytokines induced through TLR7 and TLR9, genes that govern immune response.

The latest positive development--an early Christmas present of sorts for the company--comes after the developer said on Nov. 30 that it won back global rights to the oncology drug IMO-2055 from Merck KGaA, as part of the agreed-upon termination of its collaboration with the German company. The company's stock has been flat on today's news.

- here's the release

Related Articles:
Idera regains drug rights from Merck KGaA
Idera psoriasis treatment put on clinical hold
Merck KGaA nixes development of Idera Pharma cancer drug