March 9th, 2022.  Amryt Announces Successful Bioavailability Study for Mycapssa® (octreotide capsules)

Data supports a planned Phase 3 study in the treatment of carcinoid symptoms associated with Neuroendocrine Tumors (NET)

Amryt’s TPE® platform enables the oral delivery of the octreotide molecule which is otherwise delivered as an injectable. Mycapssa® (oral octreotide) is approved by the FDA for long-term maintenance treatment in acromegaly patients who have responded to and tolerated injectable treatment with octreotide or lanreotide (i.e. somatostatin analogs (SSAs)).

Pharmacokinetics (PK) Study Results 

The objective of the PK study was to demonstrate that doses of Mycapssa® up to 80mg result in the desired bioavailability and dose proportionality with an acceptable safety and tolerability profile.

The Phase 1 study was an open-label, six sequence, 3 period cross-over design, enrolling 30 healthy subjects who were administered single doses (20mg, 60mg and 80mg) of Mycapssa®. The study results showed dose linearity from 20mg to 80mg. Safety and tolerability were acceptable and in line with expectations and no serious adverse events were reported.

The study achieved its objectives, and the data supports the planned Phase 3 study in patients with carcinoid symptoms due to NET. The study results are consistent with the prior PK study which was undertaken with these higher doses (20mg, 60mg and 80mg) and compared to injectable SSA (see MPOWERED clinical trial here).  The full results of this trial are not yet available to the general public.  

The US Food and Drug Administration (FDA) has confirmed that a single positive Phase 3 study would be sufficient for approval, consistent with the 505(b)(2) regulatory pathway previously agreed. Amryt is currently finalising the study protocol with the FDA and expects to initiate the Phase 3 study in Q4 2022 (Oct-Dec). (now running late!)