(Alliance News) - Midatech Pharma PLC on Tuesday said a phase one study of MTD201 as a treatment for acromegaly and neuroendocrine tumours has begun.
The goal of the study is to assess subcutaneous administration as an additional injection route versus intramuscular administration.
Acromelagy is hormone disorder which can cause bones in the hands, feet, and face to get bigger. Neuroendocrine tumours affect the cells responsible for releasing hormones.
A previous 2018 study already found that MTD201 had a better long-acting clinical profile when administered as a intramuscular injection compared to Novartis AG's drug Sandostatin. This dosing method study will decide which method of administration will be used in Midatech's pivotal registration study starting 2020.
The first cohort of healthy volunteers in this newer study have been dosed, being 14 of the 28 subjects. The cohort all received one dose of Sandostatin on Friday last week, followed by either a subcutaneous or intramuscular dose of MTD201 on Monday this week.
The other 14 subjects will experience the same procedure later this week, which will complete the study's dosing phase. All subjects will be observed for 63 days before data is analysed. Top line results are due by 2019 end or early 2020.
Shares in Midatech were up 2.2% at 6.26 pence in London late on Tuesday morning.
By Anna Farley; annafarley@alliancenews.com
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