Programs

MAJOR GLOBAL HEALTH CARE CONCERN

T deficiency is a global phenomenon. T deficiency can arise for a number of reasons:

Primary and Secondary Hypogonadism

Acquired Hypogonadism
(e.g. in chemotherapy, AIDS, chronic lung disease and renal failure, cirrhosis, opioid treatment and critical illness).

Late (or Adult) Onset Hypogonadism

The prevalence of low T levels in men is linked with conditions such as:

Reduced Libido & Infertility

Obesity

Diabetes & Metabolic Syndrome

Orphan Diseases (e.g. Klinefelter Syndrome)

high blood pressure, high blood sugar, unhealthy cholesterol levels, & belly fat

Source: TranslAndrolUrol. 2017 Apr; 6(2): 183–191; The Journal of Clinical Endocrinology & Metabolism, 2007, 92(11):4241–4247

The problem

Current exogenous T treatments may carry high risk for patients:

Increased risk of stroke, heart
attack & high blood pressure

May promote
prostate tumorigenesis

May reduce intratesticular T
and sperm numbers
leading to infertility

ACESIS’ SOLUTION

Our T inducing proprietary family of peptides are expected, after rigorous testing and necessary regulatory approvals, to be a safe treatment for male hypogonadism

Comparison of acesis’s novel solution with marketed low t treatments

Acesis’ plans to fulfil an unmet market need

ATTRIBUTE	ACESIS’ PEPTIDE MARKETED T PRODUCTS	MARKETED T PRODUCTS
Active compound	Peptide (non-steroidal)	100% - Anabolic steroids
Intervention	T Restoration (Induces the body to recover T)	100% - T Replacement (Introduces excess exogenous T)
Administration	Oral	>95% - Transdermal, Injections etc.
Safety	No significant side effects expected & in preclinical testing our peptides are bioactive in very low concentrations	100% - Steroidal side effects FDA Black Box Warning*
Abuse/Misuse	None expected	100% - Possible steroidal abuse

*”A black box warning is the FDA’s most stringent warning for drugs and medical devices on the market alerting the public and health care providers to serious side effects, such as injury or death” https://www.drugwatch.com/fda/black-box-warnings

Pipeline

Orally bioavailable ACE-167 Peptide: Platform Product Will be Developed for Additional Indications

INDICATION	CONCEPT/DISCOVERY	PRECLINICAL EFFICACY in relevant animal models	Preclinical IND ENABALING STUDIES	PHASE 1	VALUE ADDED EVENT
Primary Hypogonadism (PH)			8 -22 months	~ 24 months	Peptide manufacturing Pivotal animal trials IND submission to FDA
Secondary Hypogonadism (SH)			8 -22 months	~ 24 months	Peptide manufacturing Pivotal animal trials IND submission to FDA
Orphan Diseases: - Klinefelter Syndrome(PH)		12 –18 months	18 – 24 months	*	Initiate partnerships w/ academic or private partner Obtain orphan drug designation
NAFLD (non-alcoholic fatty liver disease)		16 –20 months	> 24 months	*	Initiate partnerships w/ academic or industry partner
Pre-Diabetes/Diabetes type II		> 18 months	> 24 months	*	Initiate partnerships w/ academic or industry partner
Overweight/Obesity		> 18 months	> 24 months	*	Initiate partnerships w/ academic or industry partner
CACHEXIA - Cancer - HIV		> 18 months	> 24 months	*	Initiate partnerships w/ academic or industry partner

Acesis’ clinical lead ACE-167 peptide is a platform PRODUCT to be used across many disease indications where there is strong scientific evidence linking low T to conditions such as obesity and type II diabetes and as per list above; ACE-167 is targeting the same “protein to protein interaction” of 14-3-3ε with VDAC1, across all proposed indications with the biological effect to restore/increase endogenous low T levels; additional clinical studies will be required for testing the efficacy of our product candidate in the above indications.

Starting of timelines is triggered after the successful closing of financing

* Additional funding will be required for testing Acesis’s drug candidate(s) in these indications

Market opportunity

Find out more >