Testosterone Treatment Research

Testosterone Replacement ProgramIAS-167A.

In May of 2015, the FDA issued a cautionary notice regarding the use of existing testosterone replacement products to treat low testosterone in aging men due to the possible increased risk of heart attack and stroke.1 We are developing a drug to replace current treatments for low testosterone which we believe will not cause dangerous side effects.

Our lead testosterone replacement therapy candidate under development, IAS-167A, is a peptide compound that 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, a condition known as hypogonandism. IAS-167A is a first in class solution with a novel target eliminating the need for administering testosterone externally by allowing the body's own regulatory mechanisms to normalize production of testosterone by the testes.

IAS-167A is novel new chemical entity in a highly competitive field that management estimates represents a $2.0 billion market opportunity. Our strategy is to 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.

IAS761A 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.

Our goal is to build additional value in our novel peptide technology by continuing work to advance this promising product candidate toward preclinical testing in multiple therapeutic areas. For example, we intend to investigate either in our own research or in alliance and/or in collaboration with third parties if our IAS-167A peptide can be used in restoring testosterone levels for rare disorders such as Klinefelter's syndrome or PraderWilli syndromes.