Macimorelin Diagnostic

The Only Approved Oral Diagnostic for Adult Growth Hormone Deficiency

Adult Growth Hormone Deficiency

U.S. FDA approved
European Commission approved

Our lead product, macimorelin, is the only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). Macimorelin is currently marketed in the United States under the tradename Macrilen™, through a license agreement with Novo Nordisk. Through a license agreement with Consilient Health Ltd, macimorelin will be commercialized in Europe and the United Kingdom upon receipt of pricing and reimbursement approvals in the particular country. Additionally, we have entered into a distribution agreement with MegaPharm Ltd. under which MegaPharm will seek regulatory approval and then commercialize macimorelin in Israel and the Palestinian Authority.

 

We are also leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD), an area of significant unmet need, in collaboration with Novo Nordisk.

Macimorelin, a ghrelin agonist, is an orally active small molecule that stimulates the secretion of growth hormone (GH) from the pituitary gland. Stimulated growth hormone levels are measured in blood samples after oral administration of macimorelin for the assessment of GHD.

“Because the macimorelin test is simple, well tolerated with minimal side effects, and of shorter duration with only 3 to 4 blood draws compared to other GH–stimulation tests, it is anticipated that its use will increase over time.”*

“Very promising test that is easy to conduct with high reproducibility, safety, and diagnostic accuracy comparable to the ITT and GHRH plus ARG test.”*

 

AACE 2019 Guidelines (https://journals.aace.com/doi/full/10.4158/GL-2019-0405)

*AACE 2019 Guidelines: American Association Of Clinical Endocrinologists And American College Of Endocrinology Guidelines For Management Of Growth Hormone Deficiency In Adults And Patients Transitioning From Pediatric To Adult Care, 2019

American Association of Clinical Endocrinologists 2019 Guidelines

Adult Growth Hormone Deficiency (AGHD)

Growth Hormone (GH) is Critical to Lifelong Health

Maintains Normal Body Stature and Regulates Metabolism

No single signs or symptoms, but recognized by:

• Metabolic syndrome

• Osteoporosis

• Muscle wasting

• Low physical/mental energy

• Impaired quality of life

Increased risk of:

• Cardiovascular (CV) issues

• Bone fractures

Adult Test Procedure  (Macimorelin)

Growth hormone not only plays an important role in growth from childhood to adulthood, but also helps promote a hormonally balanced health status. AGHD most commonly results from damage to the pituitary gland. It is usually characterized by a reduction in bone mineral density, lean body mass, exercise capacity, and overall quality of life as well as an increase of cardiovascular risks.

 

AGHD may occur in an adult subject who has a history of childhood-onset growth hormone deficiency (CGHD) or may occur during adulthood as an acquired condition.

Number of Potential Tests Annually

28,000-62,000*

14,000-28,000*

*Navigant study 2009, TVG study 2017, Huron Consulting study 2018

In other areas of the world, the incidence and prevalence of AGHD are not known, and awareness and diagnosis remain low. GH not only plays an important role in growth from childhood to adulthood, but also helps promote a hormonally balanced health status. AGHD mostly results from damage to the pituitary gland, which can be caused by tumors, traumatic brain injury, brain infarction, radiation, or infections. It is usually characterized by a reduction in bone mineral density, lean body mass, exercise capacity, and overall quality of life as well as an increased cardiovascular risk profile.

No Physician Supervision Required

 

Nurse Administered

Fasted Patient

(at least 8 hours)

Patient Drinks Solution

1 ml (0.5 mg/kg)

per kg body weight

FDA

EMA

30

45

60

90

45

60

90

-

Blood Draws

(minutes)