Anandamide-loaded Z-pods® for cutaneous lupus lesions
Atticus is utilizing a proprietary topical delivery system involving highly engineered silica particles (Z-pods®) loaded with the endocannabinoid, anandamide (AEA). AZP-AEA would be applied in a topical formulation to stabilize the highly unstable AEA and to sustainably deliver it to inflamed skin lesions, resulting in modulation of the inflammatory process via the cutaneous endocannabinoid system. Importantly, because AEA is endogenous and Z-pods are 100% amorphous silica, there are no anticipated toxicities associated with daily administration. If approved, AZP-AEA could minimize the need for off-label use of other medications known to have significant limitations and therefore could ultimately become first-line topical therapy.
Y200™-loaded Z-pods® for the treatment of androgenic alopecia
Y200 is a purified extract from a tree found in southeast Asia and it has been shown to have an effect on mitochondrial function. Deficiencies in mitochondrial activity lead to excessive skin wrinkling and hair thinning, among others. It was speculated that Y200 had poor skin penetration and a short duration-of-effect on mitochondrial function so using Z-pods as a sustained release delivery mechanism might improve the function.
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A more abundant "sister" compound to Y200 (known as Y100™) has been combined with Z-pods and a human study has been conducted in 34 healthy patients with androgenic alopecia and over 75% of patients showed demonstrable hair growth and thickening. Atticus plans to conduct a similar study with higher concentrations of Y200 with the goal to generate even more robust responses.
Sildenafil-loaded Z-pods® for the treatment of erectile dysfunction
In the first six years after FDA approval of the phosphodiesterase 5 inhibitor, sildenafil (Viagra), 23 million men worldwide filled Viagra prescriptions, with average annual sales of about $1.7 billion. However, large multi-center clinical trials have showed that 30-35% of patients fail to respond and the reported 62% prescription renewal rate at the 3-4 month follow-up visit dropped to around 30% by 6-12 months, suggesting that patients stop taking the drug for reasons other than failure of treatment. The reasons for discontinuance vary but include the inability to tolerate the side effects (headaches, facial flushing, nasal congestion, and dyspepsia).
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The Solution: A local topical application of PDE5i could hold several advantages over oral administration, including: (i) reduced side effects associated with systemic delivery; (ii) decreased variation in absorption profiles due to diet; (iii) avoidance of first-pass metabolism, potentially lowering required dose; and (iv) improved time of onset because of shorter distance to the target organ.