Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), an R&D biotechnology company focused on delivering innovative oncology and rare disease products to patients, is pleased to announce positive headline results from Study 102. The study met its primary endpoints to confirm similar pharmacokinetics and bioavailability of octreotide for subcutaneous and intramuscular routes of administration.
The results demonstrate that MTD201 can 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.
These are key advantages for patients, payors and physicians over the current standard of care. The subcutaneous route of administration is simpler, less painful, and allows 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 just 6 injections per year, thus providing a much less frequent, more cost effective and patient friendly treatment regimen. These attributes are in addition to already demonstrated advantages for MTD201, including less painful injections due to smaller needle size (21 gauge needle, compared to 19/18 gauge for SLAR), simpler, more reliable reconstitution and injection (less than 10 minutes versus up to 40 minutes for SLAR), and 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 be commenced 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 Injection deep subcutaneous injection. The study was conducted in 28 healthy subjects and following a single injection of MTD201 (either subcutaneously or intramuscularly) in early October 2019, all subjects entered a 63-day observation and sampling period to determine plasma octreotide and insulin-like growth factor-1 (IGF-1) concentrations.
The key preliminary results from Study 102 include:
· Pharmacokinetics ("PK")
- both subcutaneous and intramuscular injections produced a similar overall extended octreotide PK profile
- the octreotide release profile supports injection intervals of up to eight weeks, compared to the predominantly 4 weekly current standard of care
- inter-subject variability for MTD201 was consistent with that observed for currently commercialised long-acting octreotide products
· Pharmacodynamics ("PD")
- sustained reduction in plasma IGF-1 throughout the 63-day assessment period was similar for both subcutaneous and intramuscular injections
- MTD201 was very well tolerated. Results show 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 commencement of the next pivotal study for the clinical development for MTD201 is now underway, which is planned to commence later in H1 2020. A pivotal registration programme to support a second indication in NET is also expected to commence in 2020.
Commenting Craig Cook, CEO of Midatech, said: "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. 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."