ICO Therapeutics: Could AmpB Provide A Functional Cure For HIV?

A look at oral AmpB
As iCo Therapeutics Inc, (ICO) awaits all-important Phase II trial results in March/April 2014 on iCo-007 for diabetic macular edema (DME). We review its oral formulation of amphotericin B (AmpB). iCo recently started an in vitro study using samples from HIV patients undergoing highly active antiretroviral therapy (HAART), to assess if AmpB can lower latent viral loads, which could reduce the need for lifelong HAART in HIV/AIDS patients.

Developing oral amphotericin B
iCo is advancing an oral formulation of antifungal AmpB, a drug typically used intravenously for systemic fungal infections but associated with high toxicity. iCo anticipates that a successful oral formulation can reduce safety risks and broaden patient access to this antifungal. iCo is seeking funding for the necessary GLP/GMP preclinical work to enable Phase I testing.

Could AmpB provide a functional cure for HIV?
While HAART is the mainstay for treating HIV, it does not eradicate the virus as latent viral reservoirs form in certain immune cells, resulting in a need for lifelong therapy. Preclinical data suggest that AmpB could potentially reactivate latent HIV expressing cells while inhibiting HIV replication, which may allow the immune system to fully eradicate infected cells and possibly facilitate a “functional cure” for HIV. The “functional cure” represents a potentially disruptive holy grail in the $14bn global HIV drugs market, as other companies (eg Sangamo with SB-728) are also developing treatments seeking to lessen or eliminate the need for lifelong HAART.

In vitro AmpB study in HIV patients on HAART
iCo has started a study in which eight patients undergoing HAART (recruitment to complete in Q214) with detectable latent viral reservoirs will have their serum extracted, treated with AmpB and then evaluated in vitro to determine the effects on such reservoirs.

Valuation: C$35m EV discounts development risk
The AmpB opportunity could generate long-term value, but is at a very early stage in relation to iCo-007 for DME, the primary near-term value driver. iCo finished Q313 with C$2.1m in net cash. With a 9M13 burn rate of C$2.6m and a recent (November 2013) exercise of C$0.96m in warrants, we estimate net cash of C$2.3m as of end December 2013, and a funding runway into Q314. iCo’s EV of C$35m discounts the potential of iCo-007 in a DME market estimated at US$7bn, so positive Phase II (iDEAL study) data could generate significant upside.

To Read the Entire Report Please Click on the pdf File Below.