BioVie: Quick Rise And Fall Of An Alzheimer's Disease Drug Developer

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BioVie (NASDAQ:BIVI) announced information from aggregate shape 2 tests successful December, went up hugely, but coming it is down 60%. BIVI is simply a objective shape institution targeting specified divers illness areas arsenic Alzheimer's, Parkinson's and ascites, a liver disease. What is nan communal thread betwixt specified divers illness areas? According to BioVie, it is inflammation. A study published successful Nature Medicine recovered that neuroinflammation creates nan progression from amyloid plaque, coming successful galore older adults pinch Alzheimer's, to dementia and AD. According to nan lead writer of nan study, Dr. Tharick Pascoal, Ph.D., adjunct professor of psychiatry and neurology astatine nan University of Pittsburgh School of Medicine, PA:

Many [older adults] person amyloid plaques successful their brains but ne'er advancement to processing Alzheimer's disease. We cognize that amyloid accumulation connected its ain is not capable to origin dementia - our results propose that it is nan relationship betwixt neuroinflammation and amyloid pathology that unleashes tau propagation and yet leads to wide encephalon harm and cognitive impairment.

Ascites is an wholly different disease. In this disease, fluid collects successful nan abdomen and tin impact various soul organs. There are nary approved therapies. The illness has aggregate etiologies, but immoderate of them tin beryllium attributed to inflammation.

BioVie's pipeline consists of 2 molecules, NE3107 and BIV201. NE3107 is successful objective improvement for Alzheimer's Disease (AD') and Parkinson's illness (PD'), while BIV201 is successful a Phase 2b for refractory ascites. The pursuing is nan information from nan tests tally truthful acold (quoted from Corporate Presentation):

In Alzheimer's, a Phase 2 exploratory biomarker proceedings recovered that patients treated pinch NE3107 for 3 months experienced:

  • Reversal of their cognitive diminution arsenic measured by aggregate appraisal tools

  • Reduction of TNFα successful mode that's correlated pinch cognitive improvements

  • Reduction phospho-tau accumulation and nan ratio of phosphor-tau to amyloid beta (Aβ)

  • Improvements successful 1 aliases much encephalon regions arsenic seen from precocious functional MRI studies among patients pinch abnormal scans astatine baseline

In Parkinson's, a Phase 2 proceedings recovered that patients treated pinch NE3107 for 28-days experienced:

  • Improvements of UPDRS portion 3 people connected Day 28 compared to Day 0 that is 3+ points amended than those treated pinch levodopa unsocial astatine nan 2- and 3-hour marks. This level of superiority is considered by PD experts to beryllium clinically meaningful

  • Improvements of 6+ points among patients younger than 70 years aged (a surrogate for little illness progression)

In liver disease, BIV201 is successful Phase 2b for refractory ascites. In tests frankincense far, patients person experienced:

  • Reductions successful ascites fluid build up and hold of clip betwixt paracenteses

  • No drug-related SAEs

NE3107 is an orally bioavailable mini molecule that tin transverse nan humor encephalon barrier. Discovered astatine Hollis-Eden Pharmaceuticals (renamed Harbor Therapeutics), NE31071 is simply a synthetic analogue of a metabolite of nan adrenal hormone DHEA. DHEA is Dehydroepiandrosterone is simply a steroid precursor hormone people produced successful nan body. Synthetic versions are sometimes utilized to dainty a assortment of syndromes, nevertheless studies person not established a relationship betwixt DHEA usage and immoderate benefit. However, it appears that this is much because of deficiency of investigation alternatively than immoderate deficiency of DHEA's existent usage, because it is well-known that DHEA has galore beneficial functions successful nan body. Studies person besides shown nan cardinal anti-inflammatory effects of NE3107; nan institution now needs to beryllium these successful nan clinic.

BIV201 targets refractory ascites. In this disease, owed to liver cirrhosis caused by inflammation, ample amounts of fluid cod successful nan abdomen. Patients typically acquisition paracentesis each week to 10 days, which involves utilizing a ample bore needle to tie retired nan fluid. This achy process only gives a fewer days of symptomatic relief, and does not reside nan cardinal problem. There are nary approved drugs, and nan only curative remedy is TIPS room (transjugular intrahepatic portosystemic shunt to transmission humor travel astir nan liver) aliases a liver transplant. There are 20,000 US patients and a full addressable marketplace of $670mn.

BIV201 is simply a liquid formulation of terlipressin which is utilized successful immoderate ascites patients. Its main advantage is convenience of delivery.


BIVI has a marketplace headdress of $202mn and a rate balance of $46mn. The institution spent immoderate $11mn successful R&D and $4.5mn successful G&A. At that rate, they person rate near for 3 much quarters starting from Dec 31. Thus, nan institution is not successful a comfortable financial situation.


Anything to do pinch Alzheimer's is simply a large woody these days successful biopharma, and moreover a hint of affirmative information tin return a banal up, for illustration we saw here. However, it is telling that nan banal has settled down to much aliases little wherever it was earlier nan information drop, and that excessively successful conscionable a period aft nan spike. I statement a number of very in-depth articles connected nan subject and truthful on, but frankly, I did not want to "get into" that benignant of in-depth discussion. I took a very cursory position here, and my position broadly depended connected 2 things - nan emergence and consequent autumn successful nan banal price, and nan precarious rate position. There's different angle, arsenic good - nan banal is very, very heavily insider owned, and I americium people wary of specified stocks. Given each that, I, admittedly, avoided wasting my clip delving into nan proceedings claims and truthful on. Perhaps, if nan institution tin unafraid costs and get its banal value moving, I will return another, much thorough look. Right now, I americium firmly connected nan sidelines, which is simply a position I americium comfortable pinch for astir biopharma stocks processing therapies for Alzheimer's.

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Editor: Naga

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