Can Immune Pharma Compete with Regeneron and Anacor Blockbuster Drugs for Eczema?

Ari Zoldan | 

Immune Pharmaceuticals is competing with industry giants Regeneron and Sanofi and mid-cap company Anacor Pharmaceuticals, in an attempt to cure eczema. The micro-stock and its competitors are in the process of developing drugs for atopic dermatitis (AD), the most common form of chronic eczema. According to Dr. Neil Korman, MD, PhD, Professor of Dermatology, Case Western Reserve University School of Medicine, Cleveland, OH. “Approximately 30 million Americans suffer from eczema, a potentially severe chronic skin disease with numerous important physical and psychological implications.”

Atopic dermatitis, genetically determined and inheritable, causes the patient’s skin to be “super sensitive” to many irritants. This characteristically results in dry, and scaly patches of skin which cause intense itches and lead skin to thicken, darken, and bring bacterial infection. Mild atopic dermatitis is usually self-medicated and treated with moisturizers or emollients. Occasionally, oral antihistamines and topical steroids are cautiously used to reduce inflammation and attempt to break the “itch-scratch” cycle. The problem is that once secondary infections have irritated the rash, the patient will also need topical antibiotics, causing further complications.

This past Friday brought some potential good news as Sanofi (NYSE:SNY) and Regeneron Pharmaceuticals (NASDAQ:REGN)reported success of two late stage trials for its biological drug dupilumab, a monoclonal antibody developed for the treatment of moderate to severe AD. The drug inhibits two small anti-inflammatory proteins secreted by cells, interleukin-4 and interleukin-13, which are believed to play a role in eczema. In two phase-3 trials conducted by Regeneron and Sanofi, 1,379 patients diagnosed with atopic dermatitis were tested using dupilumab or a placebo drug. In the first study alone, over 37% of dupilumab patients saw a partial or complete clearing their skin as opposed to 10% in the placebo group. Furthermore, more than 50% of the patients receiving weekly or bi-weekly dosing, saw a 75% reduction in a Eczema Area and Severity index (EASI Score), an index used to calculate the severity of the disease. This is against a mere 15% for the placebo part of the study. Dupilumab was reported to have higher efficacy when the patient’s disease was marked by eosinophilia, a condition characterized by a high count of eosinophils in the blood. Regeneron’s Chief Scientific Officer George Yancopoulos said, “These data provide strong evidence that the IL-4 and IL-13 signaling pathway is a fundamental driver of inflammation in atopic dermatitis. Dupilumab blocked the aberrant activation of this pathway, resulting in significant efficacy without evidence of immune-suppressing side effects.”

However, Sanofi and Regeneron are not alone in working on a solution to AD. Another mid-cap company working on atopic dermatitis is Anacor Pharmaceuticals based out of Palo Alto, California. Their current treatment differs from Regeron as Anacor attempts to maintain the integrity of the skin after the irritation has already started. Anacor developed Crisaborole Topical Ointment 2%, a boron-containing molecule which is believed to inhibit the pro-inflammatory proteins that cause the symptoms of atopic dermatitis. During two Phase 3 pivotal studies conducted in July of 2015, patients with mild to moderate atopic dermatitis saw significant results when treated with crisaborole. Anacor has already hired 300 sales reps in the US as analysts are suggesting that sales may reach $2 billion for a drug priced cheaper than Sanofi and Regeneron’s.

At the same time, micro-cap Immune Pharmaceuticals (NASDAQ: IMNP) has also brought two promising drugs to the table for atopic dermatitis. Bertilimumab, a first-in-its-class monoclonal antibody, targets the protein eotaxin-1, a key regulator of inflammation in multiple autoimmune diseases. In AD patients, eotaxin-1 contributes to tissue eosinophilia, a condition associated with disease severity, inflammation and tissue damage. Working through a different mechanism of action yet within the same pathway as Dupilumab, the potential of Bertilimumab as another eosinophilia-directed therapy makes it an optimal and competitive candidate for selective immunotherapy in the AD market. Bertilimumab is currently in Phase II in Ulcerative Colitis and Bullous Pemphigoid, an orphan blistering dermatological condition. An additional small Phase II trial in AD is expected to be launched by the end of 2016.

The second drug currently under development by Immune is Nanocyclo (nano-cyclosporine), a topical treatment for atopic dermatitis and psoriasis. Formulation of Novartis’ gold-standard oral drug cyclosporine as a cream by Immune will likely allow the drug to be safely used in millions of patients with moderate cases of eczema and psoriasis and provide a very potent alternative to Anacor’s crisaborole. With these two products under development, IMNP was up 9% to $.47 on Friday, while still bringing the valuation to less than $20 million.

According to Dr. Korman, “Targeted biologic drugs currently in development such as Dupilumab, which recently reported promising results in their phase 3 trials, and potentially Bertilimumab, which is in an earlier stage of clinical development are both potentially exciting new options, particularly for patients with moderate to severe disease. Cyclosporine, a gold-standard oral drug whose use is restricted due to concern for significant systemic side effects, is now being developed as a topical agent to address the need of patients with more moderate disease eczema.”

In a market where other biologics that are used in the treatment of autoimmune disease, such as Humira, can cost up to $60,000 a year, the potential for Immune’s Bertilimumab is going to be an impressive addition to any bottom line. Regeneron and Sanofi estimate that 1.6 million patients in the U.S. can benefit from Dupilumab therapy. Under the assumption that the drug only reaches 10% of that market, and that the price of this treatment is a mere third of Humira’s, Regeneron is looking at $3.2 billion for those 160,000 patients. “There are no approved systemic therapies in the U.S. for people with moderate-to-severe atopic dermatitis, underscoring the clear unmet need. These results may bring new hope to AD patients, many of whom have suffered for years,” said Elias Zerhouni, M.D., President, Global R&D, Sanofi. That still leaves plenty of room for Immune’s Bertilimumab, a drug that has a high level of positive anticipation by dermatologists. Immune Pharmaceuticals is still under the radar screen for most investors and larger pharma companies but this may not last long.

*****M. Joseph Rubin contributed to this article.

Disclaimer: The author of this article currently owns stock in Immune Pharma (IMNP)

 

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