The AIM-listed pharmaceutical firm said it recently received the pre-submission minutes of a meeting held on October 19, 2020, by the US Food & Drug Administration (FDA), which has confirmed the outline design of the requested FM17 supplemental clinical trial.
Futura said FM71, assuming it meets its primary endpoints, will provide the FDA with the “necessary reassurance” of MED3000’s efficacy and safety for up to six months use by ED patients. The group said the FDA is also continuing to provide constructive comment on the development of a product label to achieve over-the-counter (OTC) clinical treatment status for MED3000.
The company said it has submitted a final detailed clinical study protocol to the FDA and a meeting with the regulator has been scheduled for February to agree on details primarily related to the statistical analysis plan.
Futura also said detailed planning and preparatory activities for the study are continuing and it expects patient enrolment to commence “as soon as feasible” after final advice on the final FM71 study protocol is received from FDA.
Meanwhile, the firm said following the submission for a technical file for MED3000 for treatment for ED under the European Medical Device Regulation for marketing approval as a Class 2B medical device, the European Union approval process “continues to progress well” with the technical file now actively under review by the regulator and European approval for MED3000 still targeted for 2021.
Futura also said that it is working with retained specialised corporate advisers on active commercial discussions with potential licensing and marketing partners in line with an agreed process. The company said that following an announcement in late October that it has given priority to certain negotiations for one specific region for the exclusive marketing rights for MED3000 with certain parties, these discussions have “progressed positively” and the firm has signed non-binding terms and entered into exclusive negotiations for a specific region.
The group said it continues to have “reasonable expectations” that an agreement can be reached.
“We are continuing to progress along the regulatory timeline for MED3000 and executing upon our strategic plans. Aside from the prioritised regional negotiations, Futura is making steady progress on commercial discussions in multiple other regions. We look forward to providing further updates as we move ahead on both regulatory and commercial tracks”, Futura chief executive James Barder said in a statement.
Shares in Futura were steady at 14.1p in early trading on Tuesday.