Oratrope

MIDLOTHIAN, Va., May 23, 2017 (GLOBE NEWSWIRE) — Ammonett Pharma LLC (the Company or Ammonett), a privately-held biotechnology company developing a novel, daily, orally-administered mini-pill Growth Hormone (GH) secretagogue, today announced that the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) issued a positive opinion recommending the Company’s MK-0677 (Oratrope™) for designation as an orphan medicinal product for the treatment of Growth Hormone Deficiency (GHD).

Pediatric Growth Hormone Deficiency (PGHD) in children and 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 recombinant growth hormone (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 daily injection.

“Receiving a positive opinion for Orphan Designation for Oratrope in the European Union represents a significant milestone for our global regulatory strategy for the clinical development of Oratrope,” said Michael Thorner, MB, BS, DSc, FRCP, MACP, Ammonett’s Founder and Chief Scientific Officer. “Based on previously generated clinical data, we believe Oratrope could be a potentially new effective treatment option for children with PGHD and we look forward to initiating our planned Phase 2b trial in this indication.”