Hypogonadism Treatment Research

Hypogonadism Treatment Research IAS-167A.

In May of 2015, the FDA issued a cautionary notice regarding the use of existing testosterone replacement products to treat hypogonadism (low testosterone) in men due to the possible increased risk of heart attack and stroke. We are developing an orally delivered proprietary peptide to replace current treatments for hypogonadism that we believe will not cause dangerous side effects.

Our lead hypogonadism therapy candidate under development, IAS-167A, is a peptide compound we have identified and patented that uses the body's own regulatory mechanisms to produce normal levels of testosterone in men with low testosterone levels. IAS-167A is a first in class, novel solution that we believe will eliminate the need for administering testosterone externally by allowing the body's own regulatory mechanisms to restore testosterone to normative levels without exogenous testosterone.

IAS-167A is novel new chemical entity in a highly competitive field that management estimates represents a $3.0 billion + market opportunity. Our strategy is to pursue a streamlined clinical/regulatory strategy to further develop our technology as well as identify partnership and licensing opportunities or acquirors as early in our development process as possible in order to monetize the unique benefits of IAS-167A.

IAS-761A represents, to our knowledge, the first report of induction of testicular testosterone production using non-hormonal agents. Our initial studies produced proof-of-principle data supporting a novel approach to stimulating testosterone formation in males with primary, secondary and acquired hypogonadism that increase both serum and intra-testicular testosterone levels without a suppressive effect on gonadotropins.

We have conducted initial animal studies using rats rendered hypogonadal. Treatment with IAS-167A resulted in the recovery of intra-testicular testosterone production and circulating testosterone levels without causing damaging side effects.

Our proof of concept experiments so far has demonstrated that:

  • The identified lead peptide IAS-167A rescued intra-testicular and serum testosterone formation in testes cultures ex vivo and in vivo in adult male rats rendered hypogonadal by treating them with GnRH antagonist (Cetrorelix) which suppressed LH and testosterone production

Future studies will focus on the optimization of the lead peptide IAS-167A and characterization of its stability in-vivo, evaluation of the efficacy (time-and-dose-effects) of IAS-167A to restore circulating testosterone levels in hypogonadal young LH-suppressed and aging rats (resembling more of the human testicular aging biology), formulation, route of administration, study frequency of treatment and long-term effects, and pharmacokinetics studies.

We are also working to develop, and are hopeful to license and/or find a joint development partnership for, an out of body test to identify Alzheimer's disease and related dementias through a process, or method, that we believe will be the basis for creating an early stage blood or fluid test for detecting such diseases. This research is secondary to our primary focus on hypogonadism treatment research and represents a value-added component to the Company’s technology portfolio.