(Sharecast News) - Oncology and rare disease-focussed company Midatech Pharma announced on Friday that it has received feedback from the US Food and Drug Administration (FDA) on the regulatory study for its lead product, 'MTD201 Q-Octreotide'. The AIM-traded firm outlined three scenarios for MTD201 in an announcement on 20 December, which included a single-dose pharmacodynamic study in healthy volunteers, a multi-dose study in healthy volunteers, and a study in patients.It said the FDA feedback received indicated that the first scenario - a single dose pharmacodynamic study in healthy volunteers - would not support a new drug application.With that regulatory guidance, the company said it would now focus on the second and third scenarios to determine the optimal study design for the final phase of the development of MTD201, to either establish equivalence of MTD201 compared to Novartis' 'Sandostatin LAR' (SLAR), or the development of a differentiated product with an improved clinical profile.That could therefore include a multi-dose study in healthy volunteers, as in the second scenario, or a study in patients, as in the third.Midatech said the final study protocol would be subject to the customary regulatory approvals. The MTD201 exploratory study conducted in 2018 showed MTD201 to have a number of competitive advantages over SLAR, Midatech noted, including a smaller needle size, simpler and more reliable reconstitution and injection, reduced wastage, and "significantly lower" manufacturing costs.It said the Q-Sphera technology used in MTD201 had patent protection through into the 2030s. Regulatory marketing authorisation submissions were currently planned for 2021, based on the company's commercial manufacturing plan, with Midatech expecting to generate the required clinical data within that time frame.With regards to the firm's cash position Midatech said it had "very limited" cash to enable it to continue as a going concern.Following its announcement on Friday morning, the board said it would "urgently" look to conclude its discussions with a potential strategic investor, which it had also described on 20 December.The board cautioned that there could be "no guarantee" that the company would be able to conclude those funding discussions on terms or quantum similar to those outlined in December, or at all, with it promising further announcements "as appropriate"."We are pleased to receive clarity from the regulator on the development path for our lead product MTD201 and we are excited by the prospects of the MTD201 program, as well as the Q-Sphera platform," said Midatech Pharma chief executive officer Dr Craig Cook."With the feedback from the FDA now in hand, we are in a position to finalise the advancement plan for the program as we look to capture a share of the multibillion dollar sustained-release treatment opportunities."We look forward to updating the market on our funding and our development plans."
