Idera Pharmaceuticals Reports Fourth Quarter and Full Year 2012 Financial Results and Provides Update on Autoimmune Disease Program
“During the past year, Idera has demonstrated promising clinical
activity for the use of Toll-like Receptor antagonists as a novel
approach for the potential treatment of autoimmune diseases,” said
Dr. Agrawal continued, “Our next step is to conduct a Phase 2 clinical trial in patients with psoriasis with an extended treatment period of up to 12 weeks. Based on our evaluation of the comparative profiles of IMO-3100 and IMO-8400, including the engagement of TLR8 by IMO-8400, Idera has determined to conduct this Phase 2 trial with IMO-8400. Subject to successful completion of our ongoing multiple dose Phase 1 trial of IMO-8400 and to obtaining the necessary financing to conduct this trial, we expect to initiate this Phase 2 clinical trial in the second quarter of 2013.”
“Our 2012 year-end cash and cash equivalents totaled
Financial Results
As of
Fourth Quarter Results
Net loss applicable to common stockholders for the three months ended
Full Year Results
Net loss applicable to common stockholders for the year ended
2012 Research and Development Highlights
Autoimmune and Inflammatory Diseases Program
Idera’s approach to the potential treatment of autoimmune and inflammatory diseases involves inhibiting the induction of immune responses mediated through TLR7, TLR8 and TLR9. These TLRs are known to be activated in autoimmune and inflammatory diseases by aberrant complexes that contain host RNA or DNA. The Company has two TLR antagonist drug candidates in clinical evaluation.
IMO-8400 is an antagonist of TLR7, TLR8 and TLR9.
Phase 1 Single Ascending Dose Trial in Healthy Subjects Completed
During the first quarter of 2013, the Company completed the escalating single-dose portion of a Phase 1 trial of IMO-8400 in healthy subjects.
The Company initiated the Phase 1 clinical trial of IMO-8400 in the fourth quarter of 2012 to assess the safety and the pharmacodynamic activity of IMO-8400 in healthy subjects. The single-dose portion of this trial involved three escalating dose levels of 0.1, 0.3, and 0.6 mg/kg of IMO-8400, or placebo with six subjects receiving each treatment, and was completed during the first quarter of 2013. IMO-8400 treatment was well tolerated at all dose levels, and the intended target engagement of TLR7, TLR8, and TLR9 was observed in IMO-8400 treated subjects compared to placebo-treated subjects.
The Company commenced the multiple-dose portion of this trial in the first quarter of 2013. The multiple-dose portion of this trial involves two dose levels of IMO-8400, 0.3 and 0.6 mg/kg, and placebo, with six subjects receiving each treatment of four weekly doses. The Company expects data from the multiple-dose portion of this trial to be available in the second quarter of 2013.
Next Steps in Clinical Development
The next step in the Company’s autoimmune and inflammatory diseases
program is to initiate a Phase 2 clinical trial of IMO-8400 in patients
with plaque psoriasis with a treatment period of up to 12 weeks. In the
planned Phase 2 trial, 32 patients will be randomized to receive weekly
doses for up to 12 weeks of IMO-8400 at one of three dose levels or
placebo. Safety and improvement in Psoriasis Area Severity Index (PASI)
score will be monitored throughout the study. The Company anticipates
initiation of the study during the second quarter of 2013. In
Pre-clinical studies and presentations
Dr.
IMO-3100 is a dual antagonist of TLR7 and TLR9.
Top-line Results of Phase 2 Trial of IMO-3100 in Patients with Psoriasis Announced
In
In this double-blind, placebo-controlled trial, 44 patients were randomized on a 1:1:1 basis to receive IMO-3100 monotherapy at 0.16 or 0.32 mg/kg or placebo by subcutaneous injection once weekly for four weeks with four weeks of follow-up. Assessments of safety and multiple parameters of clinical activity, including PASI score, were monitored throughout the study. In addition to the clinical assessments, biopsies of psoriasis plaques were evaluated for treatment-related changes in epidermal thickness and immune cell infiltrates consistent with the intended mechanism of action.
Previously announced top-line clinical results from this trial include:
- Treatment at both IMO-3100 dose levels was well tolerated, with no treatment-related discontinuations
- A treatment effect was demonstrated in measures of clinical efficacy in patients in both IMO-3100 dose cohorts and PASI reductions at both dose levels were sustained throughout the four-week follow-up period
- At the end of the four-week follow-up period, 48% of patients treated with either dose of IMO-3100 (12 of 25) demonstrated improvements of 35% to 90% from baseline PASI scores compared with 0 of 12 in the placebo cohort; this difference was statistically significant (p<0.005)
- The trial achieved the pre-specified clinical endpoint of reduction in PASI scores at the end of treatment in the 0.16-mg/kg dose cohort with statistical significance (p<0.02) compared to the placebo cohort, but not in the 0.32-mg/kg dose cohort
- The 0.16-mg/kg cohort also achieved, with statistical significance (p<0.02), the pre-specified clinical endpoint of improvement in plaque induration, a measure of plaque thickness, at the end of treatment and during the follow-up period
- At the end of the four-week follow-up period, 25% (3 of 12) of patients treated with 0.16 mg/kg/dose and 31% (4 of 13) with 0.32 mg/kg/dose achieved PASI 50 or greater, compared to 0 of 12 placebo patients
Skin biopsies were collected at baseline and after completion of treatment to investigate changes in epidermal thickness and immune cell infiltrates. Change in epidermal thickness was the primary endpoint for the trial. Placebo-treated patients had a median change in epidermal thickness of +7.7% compared to a median change of -6.4% among IMO-3100 treated patients; this difference was not statistically significant and the primary endpoint of the trial was not achieved. A known limitation of skin biopsies after four weeks of treatment is that psoriatic plaques do not resolve in a uniform fashion, and therefore, biopsies may not provide a representative sampling of lesions (ref: Ann Rheum Dis 2005;64:65-68).
Partnered Programs
TLR7, TLR 8 and TLR9 Agonists as Vaccine Adjuvants
Idera and
- In the first quarter of 2012, Merck selected several novel agonists targeted to TLR7, TLR8 or TLR9 for evaluation and exclusive use as vaccine adjuvant candidates under the companies' collaboration and license agreement.
Additional Proprietary Programs
The Company is seeking to enter into collaborations with third parties to advance its clinical programs in oncology and respiratory diseases and research programs in hematologic malignancies, use of TLR3 agonists as vaccine adjuvants, and applications of gene-silencing Oligonucleotide technology.
Intellectual Property
In 2012, the Company was issued 22 new U.S. and foreign patents related to its TLR-targeted compounds. Presently, the Company's intellectual property portfolio contains over 400 patents and patent applications worldwide, including over 200 patents and patent applications covering the Company's TLR-targeted compounds. In addition, the Company's intellectual property portfolio includes more than 150 patents and patent applications for antisense technology and 10 patents and patent applications for GSO technology.
Financing
In
About
Idera Forward Looking Statements
This press release contains forward-looking statements concerning
Idera Pharmaceuticals, Inc. | |||||||||||||||||||||
Condensed Statements of Operations | |||||||||||||||||||||
(In thousands, except per share data) | |||||||||||||||||||||
Three Months Ended | Year Ended | ||||||||||||||||||||
December 31, | December 31, | ||||||||||||||||||||
2012 | 2011 | 2012 | 2011 | ||||||||||||||||||
(Unaudited) | |||||||||||||||||||||
Revenues | $ | 11 | $ | 8 | $ | 51 | $ | 53 | |||||||||||||
Operating Expenses | |||||||||||||||||||||
Research & Development | 3,078 | 5,700 | 13,673 | 17,969 | |||||||||||||||||
General & Administrative | 1,265 | 1,539 | 6,279 | 7,939 | |||||||||||||||||
Total Operating Expenses | 4,343 | 7,239 | 19,952 | 25,908 | |||||||||||||||||
Loss from Operations | (4,332 | ) | (7,231 | ) | (19,901 | ) |
(25,855 |
) |
|
||||||||||||
Decrease in Fair Value of Warrant Liability | 569 | 1,974 | 675 | 1,974 | |||||||||||||||||
Other, net | (35 | ) | 97 | (14 | ) | 105 | |||||||||||||||
Net Loss | (3,798 | ) | (5,160 | ) | (19,240 | ) |
(23,776 |
) |
|
||||||||||||
Preferred Stock Accretion and Dividends | 2,730 | 4,548 | 3,210 | 4,548 | |||||||||||||||||
Net Loss Applicable to Common Stockholders | $ | (6,528 | ) | $ | (9,708 | ) | $ | (22,450 | ) | $ |
(28,324 |
) |
|
||||||||
Basic and Diluted Net Loss Per Common Share Applicable to Common Stockholders |
$ | (0.24 | ) | $ | (0.35 | ) | $ | (0.81 | ) | $ | (1.03 | ) | |||||||||
Shares Used in Computing Basic and Diluted Net Loss Per Common Share Applicable to Common Stockholders | 27,642 | 27,635 | 27,639 | 27,623 |
Idera Pharmaceuticals, Inc. | |||||||||
Condensed Balance Sheet Data | |||||||||
(In thousands) | |||||||||
At December 31, | |||||||||
2012 | 2011 | ||||||||
Cash & Cash Equivalents | $ | 10,096 | $ | 24,571 | |||||
Other Assets | 727 | 1,024 | |||||||
Total Assets | $ | 10,823 | $ | 25,595 | |||||
Total Liabilities | $ | 4,196 | $ | 7,650 | |||||
Redeemable Preferred Stock | 5,921 | 5,921 | |||||||
Stockholders' Equity | 706 | 12,024 | |||||||
Total Liabilities, Redeemable Preferred | |||||||||
Stock & Stockholders' Equity | $ | 10,823 | $ | 25,595 |
Source:
Idera Pharmaceuticals, Inc.
Lou Arcudi, 617-679-5517
larcudi@iderapharma.com