Psoriasis, a chronic inflammatory skin disease, is said to be probably one of the oldest known diseases. It is estimated that as many as 7.5 million Americans and 125 million people worldwide have psoriasis. Though there are several different types of psoriasis, the most prevalent form of the disease is plaque psoriasis.
The truth about psoriasis is that it is not just a cosmetic problem as this devastating disease causes physical pain as well as frustration and self-consciousness to the patients. There is no cure yet for psoriasis, but a number of treatments are available to manage its symptoms.
Working on the development of a treatment for patients with moderate to severe plaque psoriasis is Idera Pharmaceuticals Inc. (IDRA), a clinical stage biotechnology company.
For readers who are new to Idera, here's a brief overview of its pipeline and the upcoming events to watch out for...
The most-advanced compound in the company's pipeline is IMO-3100, which is under phase II testing in patients with moderate to severe plaque psoriasis. The phase II trial of IMO-3100 for psoriasis was initiated in April of this year and it completed the enrollment of 44 patients this month. Idera expects reporting top-line data from this phase II study by year-end 2012.
The clinical activity of IMO-3100, including the impact on Psoriasis Area Severity Index (PASI), mean focal psoriasis severity, and Physician Global Assessment (PGA) scores are being assessed in the phase II study. In addition, biopsies of psoriasis plaques are evaluated for treatment-related changes in epidermal thickness and immune cell infiltrates consistent with the intended mechanism of action, according to the company.
The completion of the phase II study for IMO-3100 in psoriasis is expected during the first half of 2013.
Amgen's Enbrel, Abbott Labs' Humira, and Johnson & Johnson's Remicade, Simponi and Stelara are some of the FDA-approved biologic drugs for psoriasis. The global psoriasis market is estimated to be worth around $4.5 billion to $5 billion.
Idera's psoriasis drug candidate - IMO-3100, is a dual antagonist of Toll-like receptor TLR7 and TLR9, which play a key role in inflammation and immunity.
Next in the company's pipeline is IMO-8400, a first-in-class antagonist of TLRs 7, 8, and 9, for the treatment of lupus. Given the fact that IMO-8400 has demonstrated preclinical efficacy - in mouse models of lupus, Idera anticipates initiating a phase I dose escalation trial during the fourth quarter of 2012 to evaluate the safety and pharmacodynamics of IMO-8400 in healthy subjects.
If all goes well as planned, the company expects to report data from the phase I lupus trial of IMO-8400 and initiate phase II trial in 2013.
In May of this year, Idera announced that its phase II compound - IMO-2055, in treatment of patients with advanced head and neck cancer, failed to improve progression-free survival. The company might seek to advance IMO-2055 through collaborations with third parties.
IMO-2055 was being developed by Idera in partnership with German drug maker Merck KGaA. But due to safety concerns, Merck KGaA halted all clinical development of IMO-2055 in July of 2011 and terminated the license agreement last November.
Idera has an exclusive license and research collaboration agreement with Merck & Co. Inc. (MRK) that was signed in December 2006 to research, develop and commercialize vaccine products containing Idera's TLR 7, 8 and 9 agonists in the fields of oncology, infectious diseases and Alzheimer's disease. Early this year, several novel Toll-like Receptor agonists targeting TLR7, TLR8 or TLR9 were selected by Merck for evaluation and use as vaccine adjuvant candidates under the collaboration and license agreement.
A quick look at the company's balance sheet...
Being a clinical stage biotechnology company, Idera has no marketed drugs. To date, almost all of its revenues have been from collaboration and license agreements.
At June 30, 2012, Idera had an accumulated deficit of $386 million and cash of $13.23 million. The cash on hand is expected to be sufficient to fund operations at least into the first quarter of 2013.
Formerly known as Hybridon Inc., the company went public in January 1996 offering its shares at $10 each. The company changed its name to Idera Pharmaceuticals Inc. in September 2005.
In June of this year, Idera received a notice from the Nasdaq Listing Qualifications staff for not being in compliance with the minimum market value requirement as the aggregate market value of the company's common stock was below $50 million for 30 consecutive business days. The company has time until December 4, 2012, to regain compliance with the market value of listed securities, or MVLS, requirement.
IDRA has thus far hit a 52-week low of $0.83 and a 52-week high of $2.19. The stock closed Tuesday's trading at $0.90, down 9% on a volume of 61,500 shares.
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