Previously known as Signum Biosciences, Signum Dermalogix has announced today that the FDA has granted them IND Status for the Isoprenylcysteine Analog known as SIG990.
Investigational New Drug status means that the FDA believes that the molecule is safe enough to commence clinical trials. This means that SIG990 is moving into Phase I of is development process.
It will be several years before rosacea sufferers might see this result in a new treatment.
With this announcement SIG990 should be added to the list of New Drugs in Development for Rosacea.
Better than Sansrosa?
We were teased in 2010 that SIG0990 was in fact better at inhibiting redness than Brimonidine, the active ingredient in Sansrosa. Whether this bears out in the human clinical trials is yet to be seen.
Rosacea News also highlighted in 2010 the development approach taken by Signum: Signum Biosciences developing SIG990 for Rosacea
From the press release is looks like this is the patent cited: Cysteinyl compounds, compositions and methods of use
PRINCETON, N.J., July 8, 2013 /PRNewswire/ — Signum Dermalogix, Inc. (“Dermalogix”) a private biopharmaceutical company focused on developing new and innovative dermatological products and services announced that its Investigational New Drug (IND) Application to evaluate SIG990 in rosacea has been cleared by the U.S. Food and Drug Administration (FDA).
SIG990 is a safe topical treatment that addresses both erythema and inflammatory lesions and thus would be a significant and potentially better therapeutic option for rosacea patients then what is currently on the market. SIG990 is an isoprenylcysteine (IPC) analog that modulates toll-like receptor (TLR) and G-protein signaling demonstrating promising results in several in vitro cell based assays and efficacy in in vivo topical inflammatory animal models.
As a new chemical entity, SIG990 recently had composition of matter IP awarded (US Patent Application No. 12/566,839).
Maxwell Stock, CEO of Dermalogix, commented, “We continue to make significant progress and are well-positioned to advance the development of our IPC compounds in dermatology. I look forward to moving SIG990 into the clinic to assess its efficacy in human subjects.”