ATC-001 for the treatment of cutaneous lupus lesions
Atticus is utilizing a proprietary quasi-topical delivery system involving highly engineered silica particles (Z-pods®) loaded with the endocannabinoid, anandamide (AEA). ATC-001 essentially creates a drug depot and sustainably delivers AEA 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, ATC-001 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.
ATC-002 for the treatment of androgenic alopecia
ATC-002 delivers Y200, a mitochondrial activating molecule. Deficiencies in mitochondrial activity lead to excessive skin wrinkling and hair loss, 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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Atticus is currently evaluating ATC-002 in a claims substantiation clinical study (randomized, double-blind, placebo-controlled, 3-arm, 180 day) to evaluate ATC-002 in subjects with androgenic alopecia. Interim data analysis shows a statistically significant improvement in the objective measure of hair counts/density. Subjective measures on quality of life and satisfaction scores are also positive.
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.