Sirbal has received a provisional safety report for its SIRB-001 cream, a multi-herbal extract of Chinese herbs under development for multiple dermatological indications, including psoriasis, scalp psoriasis, atopic dermatitis, eczema, acne, and seborrhea.
The provisional clearance allows Sirbal to commercialize and sell its SIRB-001 topical skin care products in Germany and in most European Union cuntries.
SIRB-001 is the research and development name for an aqueous mixture of three traditional Chinese medicine (TCM)-based herbs: rheum palmatum L. (da huang), rehmannia glutinosa libosch (sheng di huang), and lonicera japonica (jin yin hua).
SIRB-001-based products provide a non-toxic alternative to patients suffering from inflammatory dermal conditions such as psoriasis that can be used in place of or to complement conventional therapies, according to Sirbal.
In pre-clinical studies of mice with psoriasis, SIRB-001 was found to be beneficial and demonstrated multifaceted antipsoriatic activity by targeting hallmark features of psoriasis. The compound was also found to be safe in pre-clinical and clinical studies in caring for skin prone to psoriasis.
“We are pleased to be able to offer care based on SIRB-001 to consumers as a safe herbal-based alternative for stressed skin,” Nadav Shraibom, Sirbal’s founder and CEO, said in a recent press release, adding the “regulatory and strategic advice” Sirbal received from Diapharm was an important step in seeking commercialization partners to distribute SIRB-001 products.
Sirbal is collaborating with Diapharm GmbH & Co. and plans to market its topical skin SIRB-001 products in Europe once a manufacturer has been selected.
“Diapharm applauds Sirbal for undertaking a rigorous clinical review for its broad line of product,” said Ralf Sibbing, Diapharm’s general manager and partner.
“The dermatological market is significant,” said James Bennett, director at SNS Research.
Bennett said it’s estimated that the overall 2017 market size for SIRB-001 products in Europe alone “exceeds $6 billion with a roughly 5 percent CAGR [compound annual growth rate] for the next five years.”
In 2015, Sirbal was granted two U.S. patents for its molecular and herbal combinations for the treatment of psoriasis.
In July, Sirbal presented positive results for the anti-psoriatic activity and safety of SIRB-001 at the 5th Congress of the Psoriasis International Network in Paris, France.