Products & Research
At Archer Pharmaceuticals, Inc. (Archer), we have established a leading-edge pharmaceutical facility in Sarasota, Florida, with in-house expertise in the following areas:
- Target discovery
- Drug discovery
- Target validation
- Pre-clinical efficacy
- Small-scale manufacturing
- Phase I/II clinical trials
- Drug development
- Global marketing and licensing
ARC029 was selected from approximately 2,000 chemicals in the same class as our first-line treatment of Alzheimer’s for several reasons:
- The compound was one of the most proficient at lowering amyloid levels in the pre-clinical tests and models of Alzheimer’s disease.
- Very importantly ARC029 easily crosses the blood brain barrier, and there is evidence that it accumulates in the brain, which is important for targeting Alzheimer’s disease.
- Other drugs in the class do not cross the blood brain barrier.
- Importantly, ARC029 acts to lower the soluble forms of amyloid before they become deposits in the brain. We believe that the soluble forms (rather than the deposited forms) are the real culprit in the disease, and so reducing them is our goal with ARC029.
Current Findings in Mild Cognitive Impairment- Based on current studies, Archer has extensive safety data and a mechanism of action for how ARC029 works in the brain. Nilvadipine has been shown to have beneficial effects, such as inhibiting amyloid production, increasing amyloid clearance across the blood brain barrier, and decreasing neuroinflammation (Paris et al., 2010; Bachmeier et al., 2011). Independent research has shown that Nilvadipine may prevent cognitive decline in patients with mild cognitive impairment (MCI) and act as a disease modifying agent (Hanyu et al., 2007).
Since posteromedial hypoperfusion suggests the presence of underlying Alzheimer’s disease pathology and predicts conversion to Alzheimer’s disease (Hirao et al., 2005), most patients with MCI in this study (Hanyu et al., 2007) were at high risk of progression to Alzheimer’s disease and may also have included a portion of patients with prodromal Alzheimer’s disease. This study then suggests that ARC029 may stabilize cognitive function over time.
Archer’s open label Phase I/IIa trial of Nilvadipine in Alzheimer’s patients demonstrated its safety and tolerability, and also showed APOE-genotype dependent stabilization of cognition and improvement in executive function over the 6 week duration (Kennelly et al., 2011a & b).
These promising findings led to the creation of the NILVAD consortium to evaluate the effects of 18 months of treatment with Nilvadipine in Alzheimer’s patients in a double-blind placebo controlled Phase III trial study being conducted in nine European countries, currently underway.
ARC031 – Follow-up Compound Archer data suggest that nilvadipine and related compounds can have direct effect on lowering soluble amyloid levels independently of their impact on calcium channels. Critically, this has allowed the development of non-calcium channel blocking derivatives of nilvadipine, including ARC031. ARC031 is not a calcium channel blocker but works in the same way as ARC029 to lower soluble amyloid levels. This compound has the advantage of not having antihypertensive effects in comparable doses to ARC029, which may be an additional advantage in Alzheimer’s disease.