Company suspends enrolment to trials as coronavirus travel restrictions bite.
UK-based Destiny Pharma hopes its planned IPO will attract investor demand, backed by its promise of new anti-microbial drugs and the huge innovation gap in antibacterial development.
Destiny Pharma is banking that increased awareness of the need to tackle antimicrobial resistance will draw investors to its shares when it makes a scheduled listing on the London's AIM stock market Sept 4.
The British biotech's lead asset, dubbed XF-73, targets antibiotic-resistant bacterial infections in hospitals. Destiny Pharma's proposition to investors is that the XF drug platform offers potential to generate a new range of anti-microbial drug products which kill bacteria quickly, using a unique mechanism of action that bacteria seem unable to resist.
Supporting that are studies showing XF-73 is the only antibacterial drug to resist 55 repeat exposures to the superbug Methicillin Resistant Staphylococcus aureus (MRSA) without resistance emerging, the firm says.
"This type of feature - and this extreme resistance to bacterial resistance emergence - means that we foresee a long clinical lifetime for our products, and the ability to go into areas where resistance and antibiotic resistance is an issue for existing antibiotics, so we are clearly differentiated," said Bill Love, founder and chief science officer at Destiny Pharma.
The biotech's CEO, Neil Clark told Scrip that its initial public offering "should allow Destiny to progress XF-73 to the cusp of Phase III pivotal studies in the prevention of post-surgical Staphylococcus aureus infections during 2019."
He noted that the recent high-profile and multi-faceted review on antimicrobial resistance and the international crisis it poses should offer a receptive backdrop for Destiny Pharma's AIM listing.
"We're finding that the O'Neill Review's high exposure helps people understand what we're trying to do. It helps with attaining non-urgent funding, grants and other support such as regulatory understanding and pathways and so on."
The CEO said: "if successful, XF-73 would be the first to be specifically labelled for this new US FDA sanctioned indication; a market we believe to be worth a billion dollars in the US alone, and growing.”
Clark and Love believe XF-73 has been significantly de-risked by the completion of five successful Phase I/IIa clinical trials showing fast antibacterial action, along with evidence of a zero to low bacterial resistance profile. "The next challenge for us is replicating our safety and efficacy findings in a Phase IIb clinical trial in the US," Love told Scrip.
They believe the patent position that Destiny Pharma holds through the XF platform is strong and durable. "It's a novel mechanism and the IP is 100% owned by Destiny," Clark said.
CSO Love explained that XF drugs are designed to bind to bacterial cell walls. "They don't need to be internalized. The bacteria don't even need to be metabolically active; XF drugs still will act on the membranes and still cause the membranes to become selectively leaky, and still kill the bacteria," he said.
Evidence suggests XF-73 kills bacteria within 15 minutes. "That's extremely rapid and well within the typical replication time cycle of the bacteria. That's why we believe we see this non-resistance profile. No drug has ever shown that profile before to that extent," Love said.
Destiny management said the IPO proceeds will be used to take XF-73 through to a Phase III-ready status, at which point its hoped that a corporate partner will be brought in to progress the asset further.
"We see ourselves more as a drug development engine, so we are looking to partner XF-73 and further collaborations and partnerships down the line. We already have connections along those lines; there is interest from a range of companies across the world and the AIM listing will help us with our partnering efforts," Clark concluded.
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