CAMBRIDGE, Mass.--(BUSINESS WIRE)--
“Our next objective in Idera’s autoimmune disease program is to initiate a Phase 2 study of IMO-8400, a first-in-class TLR7, 8 and 9 antagonist, in patients with moderate-to-severe plaque psoriasis during the current quarter. This study will enable us to evaluate the continued trajectory of PASI score improvement over a 12-week treatment period and maximize the clinical benefit of the treatment,” said Sudhir Agrawal, D.Phil., Chairman and Chief Executive Officer. “We anticipate top-line data from this trial to be available by the end of this year. In addition, during the fourth quarter, we expect to be in a position to initiate Phase 2 clinical trials of IMO-8400 in other autoimmune disease indications, including lupus.”
"With cash and cash equivalents of $6.1 million at the end of the first quarter and with the $16.5 million raised recently in an underwritten public offering, we believe we have funds to conduct our Phase 2 clinical trial of IMO-8400 in patients with psoriasis and to fund our operations through year-end 2014," said Lou Arcudi, Chief Financial Officer.
As of March 31, 2013, cash and cash equivalents totaled $6.1 million. In addition, in May 2013, the Company completed a $16.5 million underwritten public offering of common stock and warrants.
First Quarter Results
Net loss for the three months ended March 31, 2013, was $4.1 million, or $0.15 per diluted share, compared to net loss of $7.0 million, or $0.25 per diluted share, for the same period in 2012. Research and development expenses for the three-month period ended March 31, 2013, totaled $2.3 million compared to $3.8 million for the same period in 2012. General and administrative expenses for the three-month period ended March 31, 2013, totaled $1.5 million compared to $1.7 million for the same period in 2012.
1Q 2013 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 Toll-like Receptor (TLR) 7, 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 clinical-stage TLR antagonist drug candidates.
IMO-8400 is an antagonist of TLR7, TLR8 and TLR9.
Phase 1 Trial in Healthy Subjects Completed
The Company initiated a 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 involved two dose levels of IMO-8400, 0.3 and 0.6 mg/kg, and placebo, with six subjects receiving treatment for four weekly doses. Dosing of the multiple-dose portion of the trial was completed in the second quarter of 2013.
The Company plans to present data from the Phase 1 trial at a scientific conference in June 2013.
Phase 2 Trial of IMO-8400 in Patients with Moderate-to-Severe Plaque Psoriasis
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 12 weeks. In this randomized, double-blind, placebo-controlled Phase 2 trial, 32 patients will be randomized to receive weekly doses for 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. This Phase 2 protocol has been approved by the Centrale Commisse Mensgebonden Onderzoek of the Netherlands. Idera anticipates initiating enrollment under this protocol during the second quarter of 2013.
IMO-3100 is an antagonist of TLR7 and TLR9.
Positive Data Presented from Phase 2 Trial of IMO-3100 in Patients with Psoriasis
Data from a randomized, double-blind, placebo-controlled Phase 2 clinical trial of IMO-3100 in adult patients with moderate-to-severe plaque psoriasis were presented at the International Investigative Dermatology meeting in Edinburgh, Scotland in May 2013. The objectives of the Phase 2 trial of IMO-3100 were to evaluate the safety and tolerability and to evaluate the clinical activity of TLR antagonism in patients with psoriasis after four weeks of treatment. Details of this presentation are highlighted on Idera’s website.
Presentation of Preclinical Data
Dr. James G. Krueger, M.D., Ph.D., of The Rockefeller University, gave an oral presentation entitled “Novel Toll-like Receptor Antagonists Strongly Decrease Expression of IL-23-induced and Psoriasis Profile Genes in a Mouse Model” in the Late-Breaking Research Symposium on March 2nd, 2013, during the American Academy of Dermatology Annual Meeting. Dr. Krueger presented data showing that, in a preclinical model of IL-23-induced skin inflammation, genes related to the production of key mediators of psoriasis, including Interleukin (IL) -17, IL-6, IL-12/23, IL-1, IL-21 Receptor and interferon-gamma, were restored toward normal levels by treatment with IMO-3100 and IMO-8400. The inclusion of TLR8 activity with IMO-8400 was additive to the effect on gene expression that was observed with IMO-3100.
Publications of Preclinical Data
- A Toll-Like Receptor 7, 8, and 9 Antagonist Inhibits Th1 and Th17 responses and inflammasome activation in a model of IL-23-induced psoriasis. J Invest Dermatol. 2013.
- Design, synthesis and biological evaluation of novel antagonist compounds of Toll-like receptors 7, 8 and 9. Nucleic Acids Res. 2013;41(6):3947-61
- Design of synthetic oligoribonucleotide-based agonists of Toll-like receptor 3 and their immune response profiles in vitro and in vivo. Org Biomol Chem. 2013;11(6):1049-58.
TLR7, TLR 8 and TLR9 Agonists as Vaccine Adjuvants
Idera and Merck & Co., Inc. entered into an exclusive license and research collaboration agreement in December 2006 to research, develop and commercialize vaccine products containing the Company's TLR7, TLR8 and TLR9 agonists in the fields of oncology, infectious diseases and Alzheimer's disease.
- Merck has 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.
On May 7, 2013, the Company closed a $16.5 million underwritten public offering of (i) for a combined public offering price of $0.50 per share of common stock and related warrant, 17,500,000 shares of common stock and related warrants to purchase up to 17,500,000 shares of common stock at an exercise price of $0.47 per share, and (ii) for a combined public offering price of $0.49 per pre-funded warrant and related warrant, pre-funded warrants to purchase up to 15,816,327 shares of common stock at an exercise price of $0.01 per share and related warrants to purchase up to 15,816,327 shares of common stock at an exercise price of $0.47 per share. The net proceeds to the Company from this offering are expected to be $14.7 million. The Company anticipates using the net proceeds from the offering to fund a planned Phase 2 clinical trial of IMO-8400 in patients with psoriasis, and for working capital and general corporate purposes.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals is developing a novel approach to the treatment of autoimmune and inflammatory diseases by targeting specific Toll-like Receptors (TLRs) to inhibit the induction of immune responses. The Company has two drug candidates in clinical development: IMO-8400, an antagonist of TLRs 7, 8 and 9, and IMO-3100, an antagonist of TLR7 and TLR9. Additionally, Idera has a collaboration with Merck & Co. for the use of TLR agonists as vaccine adjuvants for cancer, infectious diseases and Alzheimer’s disease. For more information, visit http://www.iderapharma.com.
Idera Forward Looking Statements
This press release contains forward-looking statements concerning Idera Pharmaceuticals, Inc. that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words "believes," "anticipates," "plans," "expects," "estimates," "intends," "should," "could," "will," "may," and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Idera's actual results to differ materially from those indicated by such forward-looking statements, including whether Idera will be able to obtain cash resources sufficient to fund the Company's operations; whether results obtained in preclinical studies and early clinical trials such as the studies and trials referred to in this release will be indicative of results obtained in future clinical trials; whether Idera’s clinical trials will commence and will be completed when expected by Idera; whether products based on Idera's technology will advance into or through the clinical trial process on a timely basis or at all and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if the Company's products receive approval, they will be successfully distributed and marketed; whether the Company's collaboration with Merck & Co, Inc., will be successful; whether the patents and patent applications owned or licensed by the Company will protect the Company's technology and prevent others from infringing it; and such other important factors as are set forth under the caption "Risk Factors" in Idera's Report on Form 10-Q for the three months ended March 31, 2013 which important factors are incorporated herein by reference. Idera disclaims any intention or obligation to update any forward-looking statements.
|Idera Pharmaceuticals, Inc.|
|Condensed Statements of Operations|
|(In thousands, except per share data)|
|Three Months Ended|
|Research & Development||2,328||3,813|
|General & Administrative||1,527||1,689|
|Total Operating Expenses||3,855||5,502|
|Loss from Operations||(3,848||)||(5,493||)|
|Increase in Fair Value of Warrant Liability||---||(1,321||)|
|Preferred Stock Dividends||279||160|
|Net Loss Applicable to Common Stockholders||$||(4,086||)||$||(7,046||)|
Basic and Diluted Net Loss Per Common Share Applicable to Common Stockholders
Shares Used in Computing Basic and Diluted Net Loss Per Common Share Applicable to Common Stockholders
Idera Pharmaceuticals, Inc.
Condensed Balance Sheet Data
|At March 31,||At December 31,|
|Cash & Cash Equivalents||$||6,149||$||10,096|
|Redeemable Preferred Stock||5,921||5,921|
|Stockholders' (Deficit) Equity||(3,211||)||706|
Total Liabilities, Redeemable Preferred Stock & Stockholders' (Deficit) Equity
Lou Arcudi, 617-679-5517