NKTR-118-We have a large, well-controlled 52-week open label safety study, the KODIAC-08 study, that was completed in December and that analysis is ongoing and we’ll give you an update as soon as that analysis is complete. We’ll provide you with a safety analysis update this quarter, but again, that was an open label study. Astra-Zeneca, our partner, is planning NDA/MA filings in Q3 of this year pending the results of the 08 study and the pre-NDA meeting with the FDA; and they’re responsible for all regulatory and commercialization activities.
NKTR-181--So NKTR-181 is in Phase II. The program will complete by the middle of this year. We’re measuring efficacy in 200 patients with chronic pain from osteoarthritis of the knee, and we’re also starting this quarter a Phase II human abuse liability study to compare the likability of NKTR-181 to commonly abused opioids in recreational opioid users.
NKTR-192---It’s currently in Phase I. It’s finished the first part of Phases I which is a single ascending dose study to measure the pharmacokinetic profile, and the pharmacokinetic profile we set out to achieve we did achieve. The second study is underway measuring the pharmacodynamics of that single dose and then we will start the multiple dose Phase I study to establish a dose range for Phase II. And we expect to complete the entire Phase I program by the middle of this year and get the program ready for Phase II.
A new drug not named yet, but IND filing this year----I’m going to show you another program in the pain area that we expect to file an IND for this year, and I think a real interesting use of our polymer conjugate technology – much akin to what we did with NKTR-118. This is not an opioid; this is a sodium channel blocker and you know, for neuropathic pain gabapentinoids don’t work all that well. Sodium channel blockers work exceptionally well in neuropathic pain; however, because they’re CNS drugs they’re generally anti-epileptics, they come with all kind of CNS side effects – significant sedation, the potential for causing seizures, etc. So this is a CNS drug which you really can’t use for neuropathic pain in any substantial way because of the side effect profile.
NKTR-102---Ovarian Cancer--I want to talk a bit about ovarian cancer. We finished our expansion study with Etirinotecan pegol and ovarian cancer – 169 women with platinum refractory disease. All patient treatments were completed in November. The final data clearly show that 102 was highly active in platinum resistant ovarian cancer, and we plan to take this data to the FDA EMA in Q2 this year and determine opportunities and next steps in ovarian cancer.
NKTR-214 (IND Filing) Let me show you what NKTR-214 looks like in that model. Over the first twelve days we only dosed twice. You can see a dramatic control of tumor growth. We had less than 5% deaths associated with treatment. We gave one more dose at day 19 just to see how long we could extend it out and then we let it run out. But here you have the first time anyone’s used polymer conjugates to allow selective binding sites, and if we can activate tumor killing T-cells without activating the inhibitory cells; and at the same time confine the drug to tumor and not normal tissue, I think this is a very, very exciting advance in tumor immunotherapy. So we’re getting ready to file an IND on this drug.
Bayer(Amikacin) --Let me talk about Amikacin Inhale, a very important partnered program that we have with Bayer. Bayer plans to start Phase III in March of this year. This is to treat ventilator-associated pneumonia which is a very, very serious problem and has a very high mortality rate. The concept is putting Amikacin directly in the lungs. If you give Amikacin systemically you can’t get enough into the lungs to treat a resistant bacteria without causing substantial systemic toxicity.
BAX-855-----Baxter is moving into Phase III this quarter. Their study will include prophylaxis use as well as on-demand use and they plan regulatory filings for 2014. This is a fairly short study; I think it’s approximately 100 patients.
And finally—MAPP has a PDUFA date for their NKTR partnership for a migraine drug on April 15th. |
