Iterum Therapeutics PLC (NASDAQ:ITRM), an Arix Biosciences PLC (LON:ARIX) investee company, has kicked-off the second and third of three phase III clinical trials of its next-generation antibiotic.
Lead compound sulopenem is being developed to treat gram-negative, multi-drug resistant infections.
Drug resistance is one of the most pressing challenges facing the medical world currently with the Center for Disease Control in the US and its EU counterpart funding critical research in the area.
The Iterum trials are named SURE 2 and SURE 3. The former will see the drug used to treat complicated urinary tract infections, while the latter will assess sulopenem’s potential in patients with intra-abdominal infections.
In each case the drug, whether used in combination or on its own, will be measured against the standard of care.
Arix, which has 7.4% of Iterum, said it invested in the Nasdaq-listed business because it has a clear pathway to commercialisation and, crucially, reimbursement if regulatory approval is gained.
The word novel is bandied around a lot in the drugs world, but Sulopenem is new and innovative in being the only penem-type antibiotic that can be taken orally or administered intravenously. Previously, these types of drug have been via IV only, limiting their use to hospitals.
At the same time, growing resistance has reduced the effectiveness of the current batch of antibiotics that are taken by mouth, while many oral treatments for urinary tract infections are dogged by safety and tolerability concerns.
So, a tablet-form penem such as sulopenem could potentially address an unmet medical need, as well as reducing hospital stays for treatment and by extension cutting costs for insurance companies and health services left to pick up patient bills.
The potential market, meanwhile, could be significant. In the US alone, there are 25mln cases of urinary tract infection, around 4mln of which are the complex variety.
In the year to date, the Iterum share price has fallen from around US$13 a share to US$8.55 currently.
Wall Street analysts said the decline was the knock-on impact of the failures of others in the antibiotic field rather than any self-inflicted harm by the company, where progress appears on track.
A market capitalisation of US$123mln would appear anomalous for a business with a phase III drug in such a hot field of research, they pointed out.