A Unique Botanical Drug Substance: Sandalwood Album Oil (SAO) is a non-substitutable botanical drug candidate that is compositionally consistent, chemically stable and highly amenable to formulation as a dermatological product. Santalis has exclusive rights to the only sustainably-produced, ISO-compliant SAO that is produced under current Good Manufacturing Practices (cGMP) and has been accepted by the US FDA for use in advanced clinical trials.
Unique Clinical Benefits: SAO has an exceptional therapeutic profile with multiple mechanisms of action and is extremely well tolerated. SAO targets disease-specific markers (such as PDE4, IL-17) without the high cost of biologics or the toxicities of many other small molecule drugs.
An Accelerated Program: FDA guidelines for development of botanical drugs provide a lower cost and shorter timeframe for development (drugs can enter the clinic at Phase 2 with minimal pre-clinical work). SAO is listed on the FDA Food Chemical Codex as a natural flavoring ingredient and has properties that make its use in dermatology studies advantageous (A good safety profile when used topically, multiple mechanisms of action and a wide variety of formulations).
A Late Stage Portfolio:
- Lead clinical candidate is poised to enter FDA Phase 3 clinical development (HPV, est. 2017)
- Five Phase 2 programs are on-going in high-value indications (multi-$B markets)
- Multiple additional clinical candidates exist