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Aphios Corporation
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Model APH-1104 - Novel a-Secretase Modulator and Potential AD Therapeutic

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An alpha (α)-secretase modulator for ameliorating Alzheimer’s Disease pathophysiology and cognitive impairment with neuroprotection. Aphios is developing APH-1104, a more potent analog of Bryostatin-1, which is neuroprotective by α-secretase activation via novel PKC isoforms, down-regulation of pro-inflammatory and angiogenic processes and the substitution of β-amyloid for its soluble and harmless relative, s-APPα. Aphios has successfully developed and patented efficient methods for manufacturing and formulating APH-1104. In 2008, Aphios investigated APH-1104, a less potent analog of APH-1104, as an intravenous formulation for Alzheimer’s disease in an open-label n=1 clinical trial in the Bahamas. Although limited, the preliminary results of this exploratory study were striking and encouraging.

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In 2010, Aphios Corporation received a highly competitive 3-year, $2.85 million Fast Track Small Business Innovative Research (SBIR) grant from the National Institute on Aging (NIA), National Institutes of Health (NIH) to develop an oral formulation of APH-1104 for mild to moderate Alzheimer’s disease (AD) and cognitive disorders (CD). Aphios and its collaborators at Louisiana State University Health Sciences Center (LSUHSC-S) have now demonstrated by both in vitro mechanistic studies and in vivo efficacy studies that APH-1104 has tremendous clinical translation potential based on clinical safety and efficacy data. This research has discovered and identified even more potent analogs of APH-1104. We plan to develop a more potent analog, APH-1104 (Patent Pending), of APH-1104.

We will develop APH-1104 as a therapeutic for mild to moderate Alzheimer’s disease (AD) and cognitive disorders (CD). We plan to utilize other analogs of APH-1104 as backups for APH-1104. Our milestones are as follows: (1) establish cGMP for the API and FDP at the pilot-scale level; (2) establish a drug master file, design IND enabling preclinical studies and Phase I/IIa clinical trials, and draft IND package; (3) conduct FDA-necessary IND-enabling preclinical in vivo studies, including toxicology, efficacy and pharmacology, under GLP; (4) perform stability testing of API and FDP under GLP; (5) file IND for conducting Phase I/IIa clinical trial of APH-1104; and (6) conduct Phase I and IIa clinical trials of oral APH-1104.