(Sharecast News) - Biotechnology research and development company Midatech Pharma announced positive headline results from 'study 102' on Wednesday, which it said met its primary endpoints to confirm similar pharmacokinetics and bioavailability of octreotide for subcutaneous and intramuscular routes of administration.
The AIM-traded firm said the results demonstrated that 'MTD201' could deliver sustained plasma octreotide concentrations within the range needed for therapeutic efficacy, with an injection interval of six to eight weeks by either subcutaneous or intramuscular administration.
It said those were "key advantages" for patients, payors and physicians over the current standard of care.
The subcutaneous route of administration was said to be simpler, less painful, and would allow the potential for self-administration at home, with less need for hospital visits or nurse supervision to receive treatment.
An extended dose interval would reduce the annual treatment burden for patients from 12 to six injections per year, providing a much less frequent, more cost effective and patient-friendly treatment regimen.
Those attributes were in addition to already demonstrated advantages for MTD201, Midatech said, including less painful injections due to a smaller needle size, simpler and more reliable reconstitution and injection, and the flexibility for unit doses above 30mg.
Study 102 investigated the subcutaneous administration of MTD201 as an additional alternative injection route to intramuscular administration, and determined the preferred administration route to take forward into the MTD201 registration study to begin in mid-2020.
The primary endpoints were to determine the relative plasma octreotide bioavailability and pharmacokinetics of MTD201 deep subcutaneous injection, MTD201 deep intramuscular injection, and 'Sandostatin' octreotide acetate deep subcutaneous injection.
Midatech said the study was conducted in 28 healthy subjects, and following a single injection of MTD201 either subcutaneously or intramuscularly in early October, with all subjects entering a 63-day observation and sampling period to determine plasma octreotide and insulin-like growth factor-1 concentrations.
The company said the key preliminary results from study 102 included that both subcutaneous and intramuscular injections produced a similar overall extended octreotide pharmacokinetic profile.
They also showed that the octreotide release profile supported injection intervals of up to eight weeks, compared to the predominantly four-weekly current standard of care, with inter-subject variability for MTD201 said to be consistent with that observed for currently commercialised long-acting octreotide products.
Looking at its pharmacodynamics, Midatech said the sustained reduction in plasma insulin-like growth factor-1 throughout the 63-day assessment period was similar for both subcutaneous and intramuscular injections.
On its safety, MTD201 was very well tolerated, the company said, with results showing that adverse events were similar for both subcutaneous and intramuscular injections.
There were only minor and transient injection site reactions, with no differences between the injection routes.
Preparation for the start of the next pivotal study for the clinical development for MTD201 was now underway, which was planned to begin later in the first half.
A pivotal registration programme to support a second indication in NET was also expected to start in 2020.
"We are very pleased with the positive results of Study 102. It confirmed both the subcutaneous dosing route for MTD201, as well as the potential for extended dosing intervals," said chief executive officer Craig Cook.
"These are key advantages for patients, physicians and payors, being the first therapy to offer this, and also gives Midatech a competitive advantage versus others as we move the product through to potential approval."
At 1549 GMT, shares in Midatech Pharma were up 54% at 4.24p.
11 Apr 2016 12:20