Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), a biotechnology company developing Toll-like receptor (TLR) targeted product candidates for the treatment of autoimmune diseases and as vaccine adjuvants, today reported its financial results and business highlights for the third quarter ended September 30, 2012.
Net loss for the three months ended September 30, 2012, was $4.8 million, or $0.17 per diluted share, compared to a net loss of $5.5 million, or $0.20 per diluted share, for the same period in 2011. For the nine-month period, the Company's net loss was $15.9 million, or $0.58 per diluted share, compared to a net loss of $18.6 million, or $0.67 per diluted share, for the same period in 2011.
“During 2012, we have met the key objectives of our autoimmune disease drug development program,” said Sudhir Agrawal, D.Phil., Chief Executive Officer of Idera Pharmaceuticals. “Recently, we completed recruitment of patients with psoriasis in our Phase 2 trial of IMO-3100 and anticipate top-line data for some of the endpoints of this study to be available by year end. In addition, the Investigational New Drug (IND) for our second candidate, IMO-8400, is currently active and we anticipate announcing the initiation of the clinical development for the treatment of lupus as the first indication during November. We expect that data from these studies will inform our decisions on the next steps in the development of our autoimmune disease program.”
“We are pleased to have strengthened the Company’s balance sheet with the recently completed $7 million financing,” said Lou Arcudi, Chief Financial Officer of Idera Pharmaceuticals. “With the proceeds from this financing and the Company’s cash and cash equivalents at the end of the third quarter, Idera is well-positioned to reach key near term milestones in our autoimmune disease program.”Recent Business and Clinical Highlights
- In the third quarter of 2012, the Company completed enrollment in a Phase 2 randomized, double-blind, placebo-controlled, multi-center clinical trial of IMO-3100 in patients with moderate to severe plaque psoriasis. IMO-3100, a dual antagonist of TLR7 and TLR9, is the lead clinical candidate being developed by the Company initially for the treatment of psoriasis. In this study, 44 patients with moderate to severe plaque psoriasis were randomized 1:1:1 to receive IMO-3100 at 0.16 or 0.32 mg/kg or placebo by subcutaneous injection once weekly for four weeks. Assessments of safety are being performed throughout the treatment and four-week follow-up periods. Psoriasis intensity, using Psoriasis Area Severity Index (PASI), mean focal psoriasis severity and Physician Global Assessment (PGA) scores, will be assessed pre- and post-treatment. Skin biopsies of psoriasis lesions will be obtained to determine mean epidermal thickness prior to treatment and at end of treatment. Analyzed by a central laboratory, the biopsy analysis also includes immunohistologic staining for changes in immune cell infiltrates and cytokine expression. The Company anticipates reporting top-line data for some of the endpoints of the trial by year-end 2012.
- The Company announced in the third quarter of 2012 that its IND application for IMO-8400 with the US Food and Drug Administration (FDA) became active. IMO-8400 is an antagonist of TLRs 7, 8 and 9, which the Company is developing initially for the treatment of lupus. The Company anticipates announcing the initiation of a Phase 1 clinical trial during November 2012 to evaluate the safety and pharmacodynamics of IMO-8400 in healthy subjects. Following successful completion of the escalating single- and multiple-dose Phase 1 study and additional funding, the Company expects to initiate a Phase 2 clinical trial of IMO-8400 in lupus patients.
- In October, the Company made a presentation entitled “Inflammasome Activation is Blocked by Antagonists of Endosomal Toll-Like Receptors: Implications in Treatment of Autoinflammatory Disorders” at the 8th Annual Meeting of the Oligonucleotide Therapeutics Society. In this presentation, new data from preclinical studies showed that in the studies selective inhibition of Toll-like Receptors (TLRs) 7, 8, and 9, which play a key role in inflammation and immunity, resulted in inhibition of inflammasome activation and induction of Interleukin 1 beta (IL-1β), a pro-inflammatory cytokine that has been shown to be involved in Behçet's disease, non-infectious uveitis, cardiovascular disease, and other auto-inflammatory diseases.