This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Idera Pharmaceuticals Announces Results Of Phase 1 Clinical Trial Of IMO-8400, Toll-like Receptor Antagonist Drug Candidate For Autoimmune And Inflammatory Diseases

Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) announced results of a Phase 1 clinical trial of IMO-8400, a first-in-class antagonist of Toll-like Receptors (TLRs) 7, 8, and 9 being developed for potential applications in autoimmune and inflammatory diseases. In this trial, IMO-8400 was administered at single escalating dose levels and multiple dose levels weekly for four weeks in healthy subjects. IMO-8400 was well tolerated at all dose levels. IMO-8400-treated subjects showed inhibition of TLR 7-, 8-, and 9-mediated cytokines, including tumor necrosis factor-alpha (TNF-α), interleukin-1 beta (IL-1β), interleukin-6 (IL-6), interferon-alpha (IFN-α), and other pro-inflammatory cytokines. These results were presented at the 13th Annual Meeting of the Federation of Clinical Immunology Societies (FOCIS), held on June 27-30, 2013, in Boston, MA.

"We are very pleased with the safety and tolerability of IMO-8400 in this trial. Further, IMO-8400 showed strong and sustained inhibition of TLR7-, 8-, and 9- mediated cytokine induction," said Robert D. Arbeit, M.D., Vice President of Clinical Development. "Based on these encouraging results, we have initiated a randomized, double-blind, placebo-controlled Phase 2 trial of IMO-8400 in patients with psoriasis to evaluate PASI score improvement over a 12-week treatment period at three dose levels."

“We anticipate data from the ongoing Phase 2 trial to be available by year-end. Results from this study will inform our decisions regarding later stage clinical development of IMO-8400 in patients with psoriasis and clinical development in other indications,” said Sudhir Agrawal, D.Phil., Chairman and Chief Executive Officer. “IMO-8400 has potential applications in a broad range of autoimmune and inflammatory diseases, in which TLRs 7, 8, and 9 are implicated in exacerbating the disease.”

Phase 1 Clinical Trial Results

  • IMO-8400 was well tolerated in single- and multiple-dose regimens at all dosages
  • The intended pharmacodynamic mechanism of action was demonstrated in IMO-8400 treated subjects
  • Cytokine induction mediated by TLRs 7, 8, and 9 was inhibited in IMO-8400 treated subjects and not in placebo treated subjects
  • The induction of multiple cytokines was inhibited, including TNF-α, IL-1β, IL-6 and IFN-α
  • Inhibition of cytokine induction was sustained for seven days after dosing with IMO-8400
  • Pharmacokinetics showed IMO-8400 was rapidly cleared from plasma with no accumulation
  • Pharmacodynamic results support a weekly dose regimen for evaluation of IMO-8400 in clinical development in autoimmune disease indications

About the IMO-8400 Phase 1 Trial in Healthy Subjects

A Phase 1 clinical trial of IMO-8400 was conducted to assess the safety, pharmacokinetic and pharmacodynamic activity in healthy subjects. This randomized, double-blind, placebo controlled trial enrolled 42 healthy subjects. The single-dose portion of the 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. 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 each treatment for four weekly doses. Safety and tolerability were monitored throughout the study. Pharmacokinetic activity and pharmacodynamic activity were monitored at specific times.

1 of 3

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 17,051.73 -48.45 -0.28%
S&P 500 1,973.63 -4.59 -0.23%
NASDAQ 4,424.7040 -7.4420 -0.17%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto
Advertising Partners

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs