Futura Medical PLC (LON:FUM) saw its shares rise in late morning trading as the group said it is “delighted” by the “constructive feedback” proffered by regulators in both the UK and US reviewing the clinical trial requirements for MED2002, a breakthrough gel for erectile dysfunction (ED).
Crucially, written responses from America’s Food & Drug Administration and the Medicines & Healthcare products Regulatory Agency (MHRA) here in Britain support its timeline, which sees marketing approval for the product in the second-quarter of 2019.
It has been recommended Futura evaluates higher dosing regimes “to optimise efficacy across the spectrum of all ED patients”.
It has also been asked to obtain “limited additional safety data”.
In reaction, Futura Medical shares gained 2.7%, or 1.5p at 57.0p.
Phase III trial gets underway later this year
A phase III clinical trial is set to get underway in the fourth-quarter following the release of phase II data released last September supporting MED2002’s efficacy, safety and speed of onset.
Futura chief executive James Barder said: "We are delighted by the constructive feedback provided on the remaining development pathway for MED2002, our topical gel for ED, from both the US and UK regulatory authorities.
“We believe that to have the remaining development programme aligned with the authorities' suggestions, and with no expected impact on overall timelines, this is an excellent outcome and should provide reassurance for shareholders and prospective licence partners alike.
“We look forward to updating shareholders further on the development and commercialisation of a product that has the potential to be the world's fastest-acting treatment for ED."
The company’s shares rocketed last September on the back of the phase II clinical trial results.
For it meant Futura essentially had a differentiated product in a market worth US$5bn currently dominated by top-selling drugs, such as Viagra and Cialis, that have limitations.
City broker N+1 Singer said it thought MED2002 had “significant potential”, which scored success across all groups tested – mild, moderate and severe cases – but did particularly well in men with mild ED.
Some 82% with the mild form of the condition said the gel began working within 10 minutes, with 54% reporting onset within five minutes.
No safety concerns were registered, which means the gel could be positioned as a consumer health product at the right dosage as well as being a prescription-based medicine.
Research commissioned by Futura found a widespread dissatisfaction with the current crop of ED pills, with the speed of onset being the most common complaint.
MED2002 provides a far more rapid solution to what's out there currently. It takes five to ten minutes before the effect is felt versus 20 for the likes of Viagra.
All of this provides an opportunity: a ready-made market of men who either can’t or don’t like taking the current help available.
It is probably more appropriate to classify Futura as a med-tech rather than a traditional pharma or biotech firm. And this is a crucial distinction.
For what it has created is a mode of action that gets drugs through the skin more quickly and effectively than other gels of this type.
In March Futura said it had been “very encouraged” by the high level of commercial interest from potential licensing partners.
Other potential indications
MED2002 a patented delivery method that has many other uses. For erectile dysfunction, it is incorporated with glyceryl trinitrate, which has been used to treat angina for decades.
You won’t be surprised to learn, then, the technology is being developed to carry traditional and well tolerated painkillers quickly and effectively to the point they are most needed.
It means the company is not a one trick pony – it has a pipeline quick-to-market products that have consumer and medical indications.
The company has already developed CSD500, an erectogenic condom that is now on sale.
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