Saturday, January 31, 2015

Nuplazid for Juvenile Psychosis

Acadia plans to run a phase 2 trial using their lead drug Nuplazid (pimavanserin) for juveniles with psychotic symptoms in the second half of this year.  This is an area that would be addressing an unmet need, because the current anti-psychotics being used today have been difficult to tolerate for an extended period of time. Some of the side effects exhibited include weight gain, high blood sugar, pleasurelessness, movement disorders, low energy and motivation. The current drugs being used for this age group include, Risperdal, Zyprexa, Serequel, Geodon, Clozaril, and Abilify.  The company plans on testing Nuplazid for patients in the maintenance phase of schizophrenia, which is the time period between acute psychotic episodes, and it will be tested as mono-therapy treatment. We'll have more to say on this trial, and the market opportunity in the future. Thank you for reading.

Wednesday, January 14, 2015

Acadia - JP Morgan Healthcare Conference ($33.76)

Acadia (ACAD) presented yesterday at the annual JP Morgan Healthcare Conference.  Not much new information was presented, just a reiteration of timelines, and current, and future clinical trials.  The breakout session afterwards yielded a few questions regarding their phase 2 ADP (Alzheimer's Disease Psychosis) trial.  
  • The company is looking for a -3 point reduction from placebo on the hallucinations and delusions sub-scale at six weeks, as primary endpoint.
  • Also at six weeks into the trial, they will be using a more broad scale, the NPI - NH (Neuropsychiatric Inventory-Nursing Home) and the CMAI-SF (Cohen Mansfield Agitation Inventory - Short Form) respectively.  The NPI-NH scale encompasses behavioral as well as psychosis as one complete measure.
  • At 12 weeks, they will measure cognition, functional and behavioral performance since the beginning of the trial using the ADCS - CGIC (Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change).
Bottom Line:  Management did another fine job explaining the science, clinical trial updates, and timelines for 2015.  Thank you for reading.

Sunday, January 11, 2015

Lundbeck Clinical Trials - Update

Lundbeck and their marketing partner Otsuka (the manufacturer of the #1 selling drug Abilify) are major players in the central nervous system (CNS) space.  An update on new phase 3 trial data for depression and schizophrenia are listed below.  The links are below.

12-10-2014
Lundbeck 2014 Press Releases
Trial: (NCT01360645) Phase 3
Brexpiprazole as adjunct for Major Depressive Disorder (MDD)
Study 1 (2mg + ADT (N=175): -3.21, p=0.0002)  MADRS

12-11-2014
Lundbeck 2014 Press Releases
Trial: (NCT01396421) Phase 3
Brexpiprazole as mono-therapy for adults with Acute Schizophrenia.
Total Score (4mg: -19.65, p=0.0006) PANSS

Both studies achieved significant efficacy results, which may lead to approval from the FDA mid 2015.  Brexpiprazole has patent exclusivity through 2026.