Midatech Announces Interim Results from Proof of Concept Exploratory Study for its MTD201 Q-Octreotide Programme and Q-Sphera™ Microsphere Technology.
The double-blind exploratory study compared tolerability, pharmacokinetics and growth hormone profiles after 30 mg intramuscular injections of MTD201 or Novartis' Sandostatin® LAR® in 24 healthy subjects. The primary objectives of this exploratory trial were to compare the sustained release profile of MTD201 to that of SLAR and to inform the design of a follow-on pivotal registration study.
Results from the study indicate that MTD201 produces a safe and effective sustained-release profile of octreotide, supporting a once-monthly treatment interval, as is indicated for SLAR. Therapeutic octreotide concentrations were achieved, and growth hormone levels were suppressed in this trial by an average of 25%, comparable with SLAR. The release profile of MTD201 was consistent in all subjects and showed no measurable burst release or dose-dumping. This reflects the precision and tuning available with the Q-Sphera microsphere platform.
MTD201 treatment was well-tolerated and the number of adverse events was low, similar to SLAR. Injection site reactions were generally mild and short-lived. Pain at the injection site was reported in 8% (MTD201) and 25% (SLAR) of subjects, and injection site tenderness in 8% (MTD201) and 83% (SLAR) of subjects.
SLAR injections were administered using the pre-packed, larger 19G needle, while MTD201 was given via a smaller 21G needle. This is a key advantage of MTD201 and the Midatech Q-Sphera™ technology compared to SLAR, in addition to other important potential benefits including a simpler and quicker reconstitution process, fewer reconstitution errors and wastage, and fewer needle blockages.
Based on these interim results, Midatech believes that MTD201 has been shown to be safe with advantageous sustained-release properties that support the continued development of a long-acting octreotide product alternative to SLAR. The favourable and improved 'no-burst' and lower variability in the profile of MTD201 suggests a distinct and improved product, rather than an equivalent product, to SLAR. In preparation for a follow-on regulatory trial, Midatech will seek additional regulatory opinion on pursuing approval for MTD201 as an equivalent product or a differentiated improved product. The Company will make further announcements regarding the next steps for MTD201 in due course.
The results from this first-in-human study also provide a successful clinical 'proof of concept' for Midatech's Q-Sphera microsphere technology as a platform for other sustained release drug candidates, either developed internally or with partners.
Commenting on the results, Dr Craig Cook, Chief Executive Office of Midatech Pharma, said: "This study has generated several positive outcomes for Midatech. First, for the MTD201 programme, whilst one objective of the study was to determine whether MTD201 was bioequivalent to Sandostatin LAR with a potentially shorter route to market, this data suggests that we have a better product with an improved clinical profile. Combined with the other advantages around smaller needle size, simpler and more reliable reconstitution and injection, this could lead to a more valuable product either to develop internally or license to pharmaceutical partners. Second, this study is a major validation and inflection point for Midatech's Q-Sphera™ technology establishing it as an exciting new sustained-release delivery platform, to administer pharmaceuticals safely, conveniently and effectively, without a burst phenomenon, and over a prolonged period. After five years of development, we are delighted to have achieved positive first-in-human data. We look forward to unlocking the full potential of our MTD201 programme as well as the Q-Sphera platform, both for Midatech and for our partners looking to capture a share of the multibillion dollar sustained-release treatment opportunities."
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).