Per the Captain: Take this bash it, pump it, spin it, I’m delivering the word from the chief’s mouth.
1 . 9:00 - Prialt acts as a clinically validated target for Z160. This provides guidance for where the drug must target. If Zlcs is able to hit this target it is expected to see the analgesic effects validated by Prialt.
Z160 demonstrates robust efficacy across a wide range of animal pain models and the highest dose shows no rotarod response.
Chung Model 13:30 – Most predictive model in measuring efficacy in Humans – At the highest doses the studies show that Z160 is on par with Prialt (Conotxin) and Gabapentin. **** Key take away - Comparable to competition without the harmful side effects.
2. 10:15 - Safety Database confirms that over 450 patients have been exposed to Z160. At the highest dose given “The database continues to grow without very severe consequences and to date (Sept 8 2013) we have not seen any neuro-psychiatric side effects. He believes this is a result of Z160 being state dependent.
3. 14:31 – Bioavailibilty – Original formulation (225mg) shows a Plasma Concentration of 65 vs. the new formulation (225mg) with a Plasma Concentration of 553. This is an 8.5 fold increase. 15:09 - “This gets us to the blood levels we believe are going to be necessary for efficacy. AUC scores - Original formulation 500 concentrations with 225 mg and new formulation of 225mg shows a 5.2 fold increase to over 2,500.
4. 17:15 - PHN is the Gold Standard for accessing clinical efficacy in neuropathic pain. This trial is well established with standard outcome measures and a clear development and regulatory path. Pfizer paved the regulatory path and many of those features are in Z’s PHN trial.
PHN also provides ZLCS with the potential for Orphan Drug designation.
Both trails are under a very efficient trail management program and results are scheduled Q4 and data has been brought to Z quickly. Corrigan sees Z160 as a value driver.
With Efficacy on par with the competition, especially morphine, in the animal studies and a 450 patient profile with no adverse side effects, I feel that we are at decent odds of moving to phase III with Z160. Add the increased Bioavailability and the Orphan Drug Designation, and it helps give me more confidence that Z160 will be positive. Below is a subset from the FDA website that leads me to believe that the pre-clinical data was reviewed already by the FDA.
The regulations say that the sponsor is required to submit all relevant data about their drug, why doesn’t the sponsor have to submit animal toxicology data for orphan designation?
In order to designate a product as an orphan drug, the scientific rationale portion of the designation application must include enough information to establish a medically plausible basis for expecting the drug to be effective in the rare disease. This is best supported by clinical trials of the drug in the rare disease or condition
However, in absence of human data, the application for orphan drug designation may be satisfactorily supported with compelling preclinical data that uses the active moiety or principal molecular structure of the proposed orphan drug in a relevant animal model for the rare human disease. Animal toxicology data, which describes the safety of the drug in animals, does not provide efficacy data, so is not useful in supporting the scientific rationale section of the orphan drug designation.
Just wanted to bump this back to the top and shed some light on what we do know about Zalicus and Z160 from the CEO himself. There are a lot of accusations and irrational thoughts swirling around this board. It does appear the Reverse Split hurt, however I think they did us a favor or we would be heading for delisting.
The main point is that the RS does not change the science behind Z160 and if you don’t feel comfortable with the information presented from Corrigan himself, than the option for you to sell comes with every account.
Also noted: z160 potentially poised for a Phase 3 start at the end of next year or early 2015. Z944 1B results by EOY and Corrigan is hopeful for another clinical candidate by the end of the year. Z is continuing their ongoing research with their collaborative partners on efficacy in cancer.