Ammonett Pharma Receives Notice of Allowance of U.S. Patent for “Detecting and treating GHD”

The U.S. Patent and Trademark Office has issued a Notice of Allowance in favour of Ammonett Pharma for Patent Application No: 15/271,542, entitled “DETECTING AND TREATING GROWTH HORMONE DEFICIENCY”. This patent claims a method of treating children who will respond to Oratrope in an equivalent manner to those treated with injectable recombinant Growth Hormone (rhGH).

PGHD in children and Growth Hormone Deficiency (GHD) in adults are conditions caused by insufficient amounts of GH in the body. Children with GHD have abnormally short stature with normal body proportions. GHD can be present at birth (congenital) or develop later (acquired). Current standard treatment of PGHD and GHD is through daily injections of rhGH.

Oratrope is Ammonett’s novel drug, ibutamoren, a small molecule, which mimics the effects of Growth Hormone release inducing hormone (Ghrelin), a natural hormone found in the stomach, which controls the release of GH from the pituitary gland. Oratrope is intended to be administered orally as a daily mini-pill, allowing the body to produce its own natural GH in a physiologically pulsatile manner over 24 hours, unlike the single daily bolus of exogenous GH delivered at present by injection.

Michael Thorner, MB, BS, DSc, FRCP, MACP, Ammonett’s Founder and Chief Scientific Officer, said that this patent allowance is another important achievement for Ammonett, adding key intellectual property protection in GHD, and complementing our current patent estate in Sarcopenia. They believe the use of Oratrope to quickly detect GHD through a simple blood draw following the oral administration in a mini-pill formulation will allow for more accurate diagnosis of GHD and enable Ammonett to identify which patients will respond to Oratrope in a manner similar to injected rhGH, which, based on their discussions with key opinion leaders in the industry, represents approximately 70% of the PGHD market. They look forward to initiating their planned Phase 2b trial in the PGHD indication.