News release: MTD201 Development Plan
Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), the R&D company focused on delivering innovative oncology and rare disease products to patients, is pleased to announce that it has finalised the development plan for its key MTD201 Q-Octreotide product, a treatment for acromegaly and neuroendocrine tumours (NET) based on the Company's unique polymer microsphere technology, Q-Sphera™ for sustained drug delivery.
Following consultations with key opinion leaders, regulators, and potential partners, the Company plans to develop MTD201 as a new differentiated product for the treatment of acromegaly and NETs. Midatech has determined that the product characteristics uniquely conferred by Q-Sphera support this positioning of MTD201 to provide the most valuable, de-risked development programme for the Company. A key factor underpinning this decision is the significant competitive advantage and value added as a result of Midatech's Q-Sphera sustained release technology. The technology has patent protection into the 2030's.
As previously reported, the pharmacokinetic and pharmacodynamic profile of MTD201 established in Midatech's 2018 Phase I exploratory study versus market leading Novartis' Sandostatin LAR (SLAR) delivered favourably on the target profile requirements needed compared to current marketed long-acting somatostatin analogues. Additional advantages demonstrated in the study include smaller, less painful needle size, simpler and error free reconstitution and injection, quicker bedside reconstitution (taking less than 10 minutes versus up to 40 minutes for SLAR), reduced wastage and significantly lower manufacturing costs.
Midatech expects further competitive advantages to be leveraged in a differentiated MTD201 product versus other players in the market, such as SLAR, to be:
- subcutaneous, rather than intramuscular, dosing. This is more convenient for patients, allows the potential for self-administration at home rather than having to come into the clinic, and is less painful to patients;
- longer dosing intervals up to 6 weeks, as opposed to 4 weeks for other products; and
- higher doses of up to 60mg compared to current 30mg doses. This means only a single injection is required for higher doses, compared to current octreotide products that require multiple doses that are both painful and very costly.
The next phase of clinical development for MTD201 as a differentiated product is scheduled to commence in H2 2019 to support a first indication in acromegaly. The pivotal registration study in acromegaly patients will seek to compare MTD201 versus placebo and is planned to commence early 2020 following receipt of approval by regulators. Prior to this, Midatech plans a short Phase I study to look to confirm the use of the sub-cutaneous route in the pivotal trial, which the Company believes will provide further significant advantages, as outlined above. The pivotal program, the costs of which are expected to be in-line with the previously stated budget expectations as outlined on 4 February 2019, is expected to conclude in 2021 and, subject to a successful outcome and expected completion on commercial scale-up of MTD201 production at the Company's manufacturing facility in Bilbao, Midatech plans to submit marketing authorisation applications the same year. Subject to funding, a pivotal registration programme to support a second indication in NET is expected to commence in H1 2020.
Commenting, Midatech's Chief Executive Officer, Dr Craig Cook, said: " We are delighted to be able to lay out our roadmap to bring MTD201 to market. Building on the exciting Phase I 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."
