ALM201 is a novel first-in-class synthetic peptide that is based on the naturally-occurring protein, FK506 binding protein-like (FKBPL). This protein has been reported to bind to the cell surface receptor CD44 and have anti-angiogenic activity in preclinical tumor models (Valentine et al., 2011; internal unpublished results). An ALM201 peptide derivative has been reported to have an association with CD44 in a Biacore® pull-down assay (Yakundi et al., 2013). Interestingly, CD44 has also been proposed to play a critical role in inflammation (Puré & Cuff, 2001) suggesting that ALM201 has both anti-inflammatory and anti-angiogenic modes of action.
ALM201 has undergone successful pre-clinical GLP safety testing and clinical development including CMC and synthetic scale-up. Furthermore, ALM201 successfully completed a phase 1 dose escalation study in patients with advanced solid tumors (EudraCT no. 2014-001175-31) demonstrating better than expected PK and tolerability after systemic dosing (see El-Helali et al., 2017). ALM201 is not cytotoxic nor immunogenic and has demonstrated a very good tolerability profile both pre-clinically and clinically.
Although initially developed as an anti-angiogenic agent for solid tumors, the dual potent anti-angiogenic and anti-inflammatory activity of ALM201 led us to examine its utility in pre-clinical models of eye disease where inflammation and neo-vascularisation cause life-limiting sight loss and where new therapeutic approaches are urgently needed.
We have demonstrated that ALM201 is a potent inhibitor of neo-angiogenesis and inflammation in pre-clinical ophthalmology models following systemic and topical administration. Following topical dosing, ALM201 distributes throughout the eye and suggests clear advantages over intra-ocular injections for back of eye conditions. Together, these properties make ALM201 a potentially relevant novel therapeutic for treating a wide range of life-limiting ocular indications.
The dual modes-of-action combined with distribution throughout the eye following topical ocular application provide great therapeutic potential to develop a novel agent for treating both front and back of eye indications.
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