Development Strategy

Optimisation Products

FTP Optimisation Products are supported by both formulation and use patents. Although again, utilising existing drugs in their approved indication, the higher level of novelty typically requires two clinical studies prior to partnering - a dosing study and then a proof of concept Phase II study.

FTP216 is an example of the four projects in the Optimisation portfolio:

FTP216 - FTP’s lead optimization project, an oral product for the treatment of testosterone deficiency
(Hypogonadism).

Testosterone is the male hormone secreted by the testis. Deficiency in testosterone can either be due to damage to the testis, primary gonadal failure, or damage to the pituitary, secondary gonadal failure. The incidence of hypogonadism has been estimated to affect 1% of young men. However, testosterone levels fall with age and there is increasing recognition of hypogonadism in aging men especially those with other conditions such as diabetes where an incidence of 17% has been reported. Testosterone deficiency results in loss of secondary sexual characteristics and hypogonadal men share a variety of signs and symptoms such as loss of body hair, decreased muscle mass, osteopoenia, increased fat mass, fatigue, decreased libido and cognitive dysfunction.

Oral testosterone is poorly absorbed and undergoes rapid degradation in the liver through first pass metabolism. Up until the last decade effective replacement therapy with testosterone was almost entirely with injections. These were oily injections which were painful and provided replacement with abnormal peak and trough levels. Patients frequently experienced swings in mood and found the injections very inconvenient. In the last decade the have been a developments in the number formulations and routes of delivery. These include skin patches, gels and buccal tablets. However, there is no oral form of the native testosterone.

FTP has gained exclusive access to technology which should make it possible to deliver testosterone orally. The objective of the development plan is show proof of concept for a first-in-class oral, once a day product for native (human) testosterone. Patent applications have already been filed and pre-clinical studies have generated strong supporting data. FTP plans to undertake a Phase 1 study in healthy individuals to determine the absorption profile of the oral product.