(Alliance News) - Midatech Pharma PLC on Thursday said it has finalised the development plan for MTD201 as a treatment in patients with acromegaly and neuroendocrine tumours using its Q-Sphera technology.
Shares in Midatech were up 4.0% at 6.50 pence in trade shortly before close.
Acromegaly is an overabundance of growth hormone, often caused by a non-cancerous pituitary gland tumour, and can cause changes in appearance, including gigantism if it develops before puberty. Neuroendocrine tumours, which can be cancerous or non-cancerous, effect the cells which release hormones into the body, with symptoms largely dependent on the location and severity of the tumours.
MTD201 will be developed as a new differentiated product for these two conditions, with a key element in this decision being the "significant competitive advantage and value added" by Midatech's Q-Sphera sustained release technology. This technology prolongs and controls the release of drugs "over an extended period of time from weeks to months".
A phase 1 exploratory study of MTD201 in 2018 found MTD201 needed a smaller, less painful needle size to be administered and met its target requirements when compared to Novartis AG's drug, Sandostatin LAR, which currently leads the market.
MTD201's next phase of clinical development as a differentiated product will begin in the second half of 2019, including its first introduction as a treatment for acromegaly, and will be compared to placebo. Before this, Midatech is planning a short phase 1 study to show the drug can be given as a subcutaneous injection rather than needing intramuscular injection, as intramuscular injections require larger needles.
The pivotal programme is to conclude in 2021 and, if successful, marketing authorisation applications will be submitted that same year.
Midatech Chief Executive Craig Cook said: "We are delighted to be able to lay out our roadmap to bring MTD201 to market. Building on the exciting phase 1 data and further leveraging the full potential of the Q-Sphera differentiating technology promises a compelling product opportunity for MTD201. The development path has been finalised in close collaboration with our distinguished advisory board, and we believe we have a clear path to potential commercialisation. We look forward to providing regular updates as the development programme progresses."
