The Pharmaceutical Research and Manufacturers of America tells us that there are currently 9 drugs in development for rosacea.
I was initially curious as to how they counted nine. Surely this number is too few ? Rosacea News follows new drugs very closely to see which ones are bubbling to the top and show the most promise for rosacea sufferers looking for more options.
Read on if you want to see what they consider are the 9 New Drugs.
Rosacea Drugs in Development
277 Medicines in Development For Skin Diseases
Washington, D.C. (June 13, 2011) — America’s biopharmaceutical research companies currently are developing 277 medicines to help the more than 100 million Americans, one third of the U.S. population, that suffer from at least one skin disease.
Skin diseases ranging from acne to psoriasis and from melanoma to infections, are more common than most people know and they come with not only a medical but also a financial burden. According to a study by the Lewin Group, the total annual cost of skin diseases was estimated at $39.3 billion in 2005.
New medicines today in the research and development pipeline offer hope of reducing the human and economic costs of the many skin disorders affecting Americans. They include:
- 74 for skin cancers, including 63 for melanoma, which affects more than 68,000 Americans each year and is the most common form of cancer in the United States.
- 60 for skin and soft tissue infections, which account for nearly 14 million outpatient visits each year.
- 41 for psoriasis, which affects about 7.5 million people in the United States, and is the most prevalent autoimmune disease in this country.
- 14 for dermatitis (eczema), where 90% of suffers get the disorder before the age of 5. Worldwide 10-20% of children have dermatitis.
- 9 for rosacea, which affects more than 14 million Americans.
In October 2010, I went on a hunt for drugs in development for rosacea, and was able to find 12 products currently in clinical trials.
The Nine Drugs in Development
Here are PhRMA’s list of nine rosacea drugs in development.
So what do they consider makes up the 9 drugs in development? PhRMA’s list is pretty short on details and background, so here is my expansion on their listing:
1. Finacea Foam
This azelaic acid based foam from Intendis is listed as being in Phase II.
A new formulation of Finacea, a foam used twice a day is being trialled. Note that they are only comparing the active against the vehicle foam, so will not be able to compare regular topical Finacea with Finacea Foam to see if the foam formulation makes any difference to the outcome (see Finacea Foam being trialled).
2. Omiganan
As far back as 2006 we started to hear about this company via Omiganan (topical cationic peptide) to be trialled as rosacea treatment where we learnt that Cutanea was due to complete a phase II clinical trial in 2007.
This latest report says CLS001 from Cutanea Life Sciences has reached Phase II completed.
3. Sansrosa
Officially listed as “COL-118 Galderma R&D, moderate to severe facial erythema, Phase III”, we know a bit about the development of CD07805/47 (formerly known as Sansrosa) from the clinical trial reports.
It has been a slow development path since we first heard about Sansrosa in 2005/2006. There are high hopes that this product will make it to the pharmacist, hopes that it will be one of the lucky discoveries to actually make it to a product.
[update:] Mirvaso has been approved by the FDA for the red face of rosacea.
4. Elorac
According to the listing, E-0301 from Elorac is in Phase II.
As we learnt in November last year, Elorac is promoting Carbamide Peroxide as a Rosacea Treatment.
5. IDP 115
IDP 115 Valeant Pharmaceuticals rosacea Phase III
Dow Pharmaceutical Sciences, which is now owned by Valeant Pharmaceuticals, has completed their trials of something they call IDP-115. Whilst details are sketchy the product appears to be similar to Rosasol, a formulation of metronidazole and sunscreen agents (see Mysterious topical IDP-115 being trialled)
6. Eucerin Redness Relief?
The ingredient Licochalcone A from Beiersdorf Research Center is listed as in Phase I Trials.
Rosacea sufferers know this company and active ingredient from the Eucerin Redness Relief product range.
The only reference I could find to efforts by Beiersdorf developing the flavonoid Licochalcone A as an official rosacea treatment is from 2009:
Natural products are of great importance in modern science as active ingredients. For example the herbal active ingredient, Licochalcone A, used by the Beiersdorf company in three Eucerin product lines to provide protection against sun-induced skin damage and medical skin care in cases of rosacea and atopic dermatitis.
As Beiersdorf announced under the banner of “Science meets nature” at a press conference at the EADV congress in Berlin, the standardised extract derived from Chinese licorice Glycyrrhiza inflata has an anti-oxidative, skin-calming and anti-inflammatory effect.
…
Clinical studies on more than 4,000 patients have confirmed the findings of the Beiersdorf researchers. An international multicentre study on 692 facial erythema and rosacea patients proved that the regular application of topical skin care products containing Licochalcone A led to a significant reduction in symptoms, a reduced need for medication and an improved quality of life.
Similarly positive results were achieved with interventions accompanying therapy in cases of atopic dermatitis, said Dr Gitta Neufang from the Eucerin skin research department in Hamburg at the Beiersdorf press conference. This was particularly true for the application of the active ingredient during the remission period.
“If we continued the treatment between two attacks as a pro-active basic therapy, there was a significant extension in some cases in the periods free from attacks,” said Dr Neufang. According to the study, the prophylactic use of products containing Licochalcone A is also very effective in treating irritations caused by UV radiation.
7. MultiStat
This product or drug family is listed as “in clinical trials”.
MultiStat is a technology licensed via Patent 7,795,302 entitled “Use of Compositions for Treating Rosacea.” to Quick-Med.
“The patent issued covers methods for treating rosacea with an antimicrobial, a retinoid, and an inhibitor of toll-like receptors in both topical and oral applications. The broad range of antimicrobials to be utilized in combination with the MultiStat family includes tetracycline, erythromycin, azithromycin, clarithromycin, milbemycin, aminoglycoside, penicillin (optimally in combination with a beta-lactamase inhibitor), cephalosporin, fluoroquinolone, streptogramin and sulfanomide.”
MultiStat is Quick-Med’s family of patented matrix metalloproteinase inhibitors (MMPIs), which have been shown to be highly effective in reducing skin wrinkling and aging.
The MultiStat family consists of 10 patented compounds, patented formulae for developing other compounds, numerous use or method patents and other intellectual property involving the use of MMP inhibition techniques in skin therapy.
These MMPIs, which have been proven effective in broad-based applications, including improving the appearance of fine lines and wrinkles associated with natural aging or sun-induced premature aging and damage, are marketed to the cosmetics industry as performance ingredients in commercially available anti-aging creams.
Quick-Med currently owns or has exclusive licenses for topical uses of MultiStat compounds for cosmetic and military applications.
8. Oxymetazoline
The PhRMA report says that V-101 from Vicept Therapeutics is at Phase II completed
All indications are that V-101 is a formulation containing oxymetazoline (as found in products like Afrin, Vicks Sinex and Visine). V-101 is being trialled in strengths of 0.01%, 0.06%, 0.1% and 0.15% (see V-101 (Oxymetazoline) starting Dose-Finding Trials).
9. Sarecycline / WC-3035 (Novel Tetracycline)
A product known as WC-3035 from Warner Chilcott is listed as being in Phase I.
Not a lot of information is easily available about this drug, but I did find a few crumbs from 2007.
In the WCRX 2007 Annual Report we find ;
WC3035. In July 2007, we entered into an agreement with Paratek under which we acquired certain rights to novel tetracyclines under development for the treatment of acne and rosacea. Currently, we are working with Paratek to select a lead compound for development.
Update: WC-3035 is now known as Sarecycline.
Paratek Initiates Phase 3 Study of Oral-only Omadacycline in ABSSSI
BOSTON, Aug. 15, 2016 (GLOBE NEWSWIRE) — Paratek Pharmaceuticals, Inc
Paratek’s second Phase 3 product candidate, sarecycline, is a well-tolerated, once-daily, oral, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the community setting.
Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains all ex-U.S. rights. Allergan initiated two identical Phase 3 registration studies in December 2014 for sarecycline for the treatment of moderate to severe acne vulgaris. Top line data are expected in the first half of 2017.
What did they Miss?
In the search last year I found a few more: Apremilast, Atralin, Calcium Dobesilate, Minocycline Foam, Nycomed Gel, Sol-Gel DER 45, SR-01 and Ziana.
The list created by PhRMA seems to be based on the same publicly available information available to us all, so it isn’t surprising that their list and my list are quite similar, but their listing was a bit short I thought.
Great finds dave, keep up the much appreciated efforts. Hopefully within a 3-4 year time frame we will have a handfull of more effective treatments.
Very interesting – THX
Thanks for the info. I’m soooo looking forward to a really effective treatment.