Want to buy a pain therapy? Nektar lays out a PhIII sales pitch
Nektar Therapeutics has a late-stage pain drug to sell to someone. And this morning the San Francisco-based biotech — which has been building a focus on oncology — added a Phase III readout showing NKTR-181’s ability to handily beat out a placebo in treating chronic pain.
The key attraction to this drug, though, is Nektar’s $NKTR billing this therapy as the first mu-opioid agonist to lessen the pain without triggering the euphoria that launched the opioid epidemic in the US.
First, the data. In the Phase III trial, patients suffering from low back pain were titrated to up to 400 mg twice daily, with pain scores dropping an average of 63%, then moved into a double-blind phase while investigators tracked average weekly pain scores for 12 weeks. Pain scores in the placebo arm increased on the rating scale by 1.46 compared to a lower 0.92 higher score for the drug arm. That was statistically significant, says Nektar, though a long way from living pain free.
And if NKTR-181 does hit the market eventually, it won’t be up against a placebo in the real world.
Nektar, though, has been enthusiastically pumping evidence that the drug doesn’t lead to euphoria, killing an effect that made opioids too popular with addicts. Its shares shot up more than 20% this morning.
Nektar execs didn’t hold back on touting the results.
“As a new molecule, NKTR-181 has a highly differentiated profile with the potential to be one of the most important advancements in pain medication,” noted CEO Howard Robin in a statement. He went on to say the company is committed to bringing the drug to patients as quickly as possible.
Just don’t expect Nektar to market the drug or file for an approval.
A couple of weeks ago the CEO told analysts:
Assuming positive Phase 3 efficacy results from the current SUMMIT-07 trial, we plan to out-license NKTR-181 to a company that has a strong presence and long-term commitment in the pain market.
That’s what Nektar did with Movantik (naloxegol), an opioid induced constipation drug which was licensed to AstraZeneca. Nektar insists that drug is a blockbuster in the making, though sales have been off to a slow start.
The big focus at Nektar now centers on NKTR-214, a preclinical biologic that the company believes can play a role in immuno-oncology. Last fall Nektar pulled the wraps off a 50/50 deal to collaborate with Bristol-Myers Squibbs to see how their experimental drug matches up with Opdivo, one of the leaders in the first wave of checkpoint inhibition.