Some notes/thoughts on Dr. Manuso's presentation yesterday -
Dronabinol -
Dronabinol Phase 2b results expected Q3-2016. Dr. Manuso said this study may possibly be pivotal/registrational, ie - potentially could file for FDA approval based on this Phase 2b (accelerated NDA).
They are looking at developing an extended release form of Dronabinol. Not only would this extend the patent life (regular Dronabinol is generic, Cor/Resp's method of use patent goes to 2025), but Dronabinol has a halflife of only 2-4 hours. In the previous Phase 2a Sleep Apnea study, the efficacy using the lower doses (2.5 mg, 5 mg) petered out halfway through the night, with only the highest (10 mg) showing good efficacy through the entire night.
Interestingly, in the first half of the night the 2.5 mg dose actually had slightly better efficacy than the 10 mg dose, though some of that might be due to the small N of the trial. The current Phase 2b is much larger, with 120 patients. If the current Phase 2b confirms good efficacy at 2.5 mg, the winning approach could be an extended release version that can maintain 2.5 mg blood levels for 8 hours. That would also minimize any unwanted side effects compared to the 10 mg dose, and extend the patent protection on the drug considerably, so a win all around. If they can get Dronabinol approved, then this extended version could be the ideal follow on product.
In the Phase 2a Dronabinol showed an approx 30% improvement in sleep apnea symptoms (slide 12).
Dronabinol is generic, but Cor/Resp have a method of use patent that runs to 2025. See other aspects of its commercial viability on Slide 15, 16
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Ampakines -
Central Sleep Apnea (brain mediated) (CX-1739) - is actually a big market, since it's found in 70% of chronic opioid users and up to 40% of heart failure patients, and 5% of all SA patients have the purely central type (as opposed to mixed and obstructive). In heart failure patients the presence of sleep apnea greatly shortens the patient's life compared to heart failure patients without sleep apnea (slide 18)
- CX-1739 - Comp of Matter patent to 2028 and Method of Use patent to 2030
- Histopath summary - Slide 22
- CX-1739 - Extremely dramatic efficacy in Central Sleep Apnea (slide 24)
The Respiratory Depression trial to start first, then Central Sleep Apnea, then looking at a Phase 2a in Pompe or Spinal Cord Injury (restoring respiratory drive) as funding allows. Dr. Manuso said they are fascinated with the potential in Pompe, spinal cord injury, and other breathing related orphan indications.
I like it. Let's get things moving :o)
