Our readers have had some great success with our Biotech Catalyst Series throughout 2016 so far. Here’s another one to watch near term that – with any luck – will keep the run of success going.
The company in question is Paratek Pharmaceuticals Inc (NASDAQ:PRTK).
Some reading might already be familiar with this one; the company has put out a string of positive data over the last twelve months or so related to its lead development program (something we’ll look at in a lot more detail shortly) and, on the back of said data, has chalked up some pretty solid media coverage in the biotechnology space.
With this said, as far as wider markets are concerned, Paratek remains very much under the radar. For those new to the company, it’s a Boston, MA based entity that’s trying to develop drugs that overcome the problem of antibiotic resistant bacteria (ARB). ARB is a massive problem in the developed world right now but it’s one that doesn’t get the attention it deserves. People die in hospital settings every day because the currently available antibiotics are unable to kill the bacteria that cause infection and – over the next twenty or so years – the problem is forecast to increase dramatically. Reports suggest that each year in the United States, at least 2 million people become infected with bacteria that are resistant to antibiotics and at least 23,000 people die each year as a direct result of these infections. Basically, the more we use the currently available portfolio of antibiotics to treat infections, the more useless they become.
The only way that we can overcome this problem is through the bringing of new antibiotics to markets – this is where Paratek comes in.
The company has developed an asset called omadacycline and it’s trying to get it approved as a treatment for a range of infections, with a primary focus on skin infections.
To date, the drug has undertaken a host of phase III trials, each of which has resulted in a demonstrable clinical benefit over a variety of standard of care therapies in these indications. In June last year, Paratek announced positive data from a phase III investigating the asset in acute bacterial skin and skin structure infections (ABSSSI), a trial that compared to the already widely used (but increasingly ineffective) linezolid. In April this year, the company announced similarly positive data from a phase III community-acquired bacterial pneumonia (CABP) that compared the drug to moxifloxacin.
Which brings us to the catalyst in focus for this week.
In August last year, Paratek kicked off a phase III trial set up to investigate the efficacy of a once-daily oral-only dosing of omadacycline to a twice-daily oral-only dosing of linezolid in patients with ABSSSI. Enrollment for this study completed in May this year and top line from the investigation is set to hit press (and we’re quoting here) during Mid-July.
We’re in the third week of July right now. We expect, therefore, that the data will hit press at some point this week. If the numbers show that the once daily dose of the drug can generate a response rate that is comparable or better than the twice daily dose of linezolid, it will bolster an already strong program and make this one a shoo-in for approval as and when it goes in front of the regulatory authorities in Europe and the US.
For reference, there are two primary endpoints, each of which caters to the respective requirements set in place by the FDA and the EMA. The FDA wants to see clinical success at the early clinical response assessment 48-72 hours after the first dose of study drug. The EMA wants to see a clinical response at the post therapy evaluation, also known as ‘test of cure’.
If the company can hit against both of these points come data release, it expects to use the data (in combination with data already collected on the back of the above-discussed trials) to submit for US approval first quarter next year and European approval shortly thereafter.
One to watch.
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Image courtesy of John Voo via Flickr
Disclosure: We have no position in PRTK and have not been compensated for this article.