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