Foamix’s Minocycline Foam – 100% Effective in Impetigo Phase II Clinical Trial With No Side Effects – 80% Improved Significantly After 3 Days of Treatment
REHOVOT, Israel, March 14, 2012 /PRNewswire/ –
Foamix, a clinical stage specialty pharmaceutical company, announced today the
successful completion of the Phase II clinical trial of Minocycline foam in Impetigo
patients. Minocycline Foam has shown to be highly effective against bacteria, including
some multi-drug resistant strains (such as MRSA).
The randomized double blind Phase II clinical study, conducted in pediatric patients
with impetigo, was designed to assess the efficacy, safety and tolerability of two
strengths of the Minocycline Foam. Patients received the foam twice daily for 7 days; and
they were checked again on day 14.
Robust efficacy was demonstrated in both 1% and 4% strength doses in this randomized,
double-blind, dose-ranging study enrolling 32 patients ages 2 to 15. Clinical response at
the end of the treatment was 92% and 100% respectively for the low or high doses; and all
patients (100%) showed success on day 14. Notably, 80% of the total patients cured or
improved significantly after 3 days of treatment.
Eight patients had MRSA and in all of them the bacterial infection was eradicated on
No drug related side effects were recorder in any of the patients throughout the
“These results are excellent; especially considering this study is the first to treat
patients with topical Minocycline. The results confirm the efficacy of our Minocycline
Foam in skin infections. It is also significant that our Minocycline Foam was
well-tolerated and that there was no evidence of clinical safety concerns since one of the
persistent barriers to the development of new classes of antibiotics has been the issue of
patient safety,” commented Dov Tamarkin, Foamix CEO. “We intend to aggressively pursue the
development of our Minocycline Foam as a first-line treatment for a range of skin
conditions, including Acne, Rosacea, Impetigo and other skin infections.”
Key Features of Foamix’s Minocycline Foam
- Minocycline is an extremely unstable compound, which currently exists only in oral dosage forms. Foamix successfully developed a stable, patient-friendly topical foam containing up to 4% Minocycline. - The topical administration of Minocycline Foam provides concentrated drug delivery to the infected lesion site, and leads to rapid cure, whilst avoiding the side effects common in the oral Minocycline treatment. - With a twice daily application, Minocycline Foam can lead to better patient compliance compared with other treatment options. - Foam is a user friendly dosage form which spreads evenly and absorbs easily without rubbing. This offers a great advantage when treating open wounds especially in small children.
Minocycline Foam Targets $1 Billion a Year Market
Foamix’s first-in-class topical Minocycline Foam is directed for the treatment of
Acne, Rosacea and Skin infections, such as Impetigo and is currently being studied in
Phase II clinical trials in Rosacea and Acne.
Targeting a patient population of more than 30 million patients in the U.S., this drug
may become a blockbuster in dermatology, with annual peak sales in excess of $1 billion.
Foam is preferred by users for topical treatment, due to its ease in spreading and quick
absorption. The current sales of oral Minocycline in the U.S. exceed $1 billion.
Success criteria – based on the recently approved Altabax (GSK)
Impetigo is a highly contagious superficial bacterial infection of the skin that
afflicts approximately 1 million patients, primarily infants and children, in the US
annually. Most cases are caused by Staphylococcus aureus, Streptococcus pyogenes, or a
mixture of both organisms. Methicillin-resistant S. aureus (MRSA) is found with increasing
frequency in this population. Impetigo is currently being treated with antibiotic
ointments, to which bacteria develop resistance.
Replace Oral with Topical
Minocycline, which is currently available only in oral tablets and capsules. A survey
recently conducted among U.S. dermatologists revealed that even though 95% of
dermatologists prescribe oral Minocycline, the majority of them (89.7%) are concerned
about the oral side effects which include upset stomach
[http://en.wikipedia.org/wiki/Abdominal_pain ], diarrhea
[http://en.wikipedia.org/wiki/Diarrhea ], dizziness [http://en.wikipedia.org/wiki/Dizziness
], unsteadiness, drowsiness [http://en.wikipedia.org/wiki/Somnolence ], mouth sores
[http://en.wikipedia.org/wiki/Mouth_sores ], headache
[http://en.wikipedia.org/wiki/Headache ] and vomiting
[http://en.wikipedia.org/wiki/Vomiting ]. Due to these side effects, in 2009 the FDA added
oral Minocycline to its Adverse Event Reporting System (AERS); a list of medications under
investigation by the FDA for potential safety issues.
The survey revealed that 77% of dermatologists would prefer prescribing a Topical
Minocycline drug over the existing oral Minocycline, assuming it was safe, effective and
approved by FDA.
It is now shown that topical Minocycline Foam offers a safe and effective alternative
to the current oral drug.
Foamix Ltd. is a clinical-stage, privately held specialty pharmaceutical company,
focused on the development of proprietary topical foams and OilGel(TM) products for
dermatology, gynecology, wounds and burn applications, as well as ophthalmic disorders.
Foamix collaborates with leading pharmaceutical companies in the creation of advanced
products with improved convenience, higher compliance and better efficacy, which are
backed by an extensive patent portfolio.
The Company’s development capabilities range from initial development of the
formulations and analytical methods to scale-up, GMP manufacturing, preclinical and
Foamix has a strong in-house pipeline. The Company’s lead product, Topical
Minocycline, is currently in 2 additional Phase II clinical studies.
To date, Foamix has 13 issued patents in the United States, covering its foam and
OilGel(TM) technology platforms. Additionally, the company has more than 140 patents and
patent applications worldwide, of which about 60 applications are filed in the U.S.
For additional information please see http://www.foamix.co.il
Dorit Hayon, Business Development Manager, Foamix Ltd., firstname.lastname@example.org,
Dov Tamarkin, CEO, Foamix Ltd., email@example.com
SOURCE Foamix Ltd