BCRX is doing just fine!
CBRE|Raleigh Recent Leasing Activity
Aug. 12, 2014
Biocryst Pharmaceuticals renewed 14,910 square feet at Nottingham Hall in Durham, NC.
This is what BCRX said about the upcoming OPUS 2b trial that is set to start this Fall:
“The benefit that you see in this type of study (OPUS 2a) with more severely affected patients becomes even stronger with more mildly affected patients.” Eligibility (OPUS 2b) will be opened up to allow lower attack rate patients in the next trial."
and Marcus Maurer MD
"So my guess is that in the clinics or in future trials (OPUS 2b) that we’ll see even better protection rate of protection from attacks using 4161."
as said earlier, come for ebola, stay for HAE.
Buyout is fine too but every MB has this same mantra.
With 4430 being accelerated into trials, a successful result provides revenue to fund the HAE program. A pivotal designation would allow this drug to be filed for an NDA next year.
Peramivir approval is coming and it will come before the PDUFA date. BCRX will receive seasonal revenue and HHS stockpiling order. ROW orders also expected.
Non-dilutive funding, a dream for most small biotechs, a likely reality for BCRX.
WHO: "Issues of safety and efficacy will be discussed together with innovative models for expediting clinical trials. Possible ways to ramp up production of the most promising products will also be explored."
Forbes: "Their goal is to develop the drug under FDA’s Animal Rule that permits non-human primate efficacy and safety studies for conditional approval as phase I human trials proceed."
Forbes: Aug. 29, 2014
BioCryst to Launch NHP Ebola Drug Safety Studies 'Within Weeks'
"Their goal is to develop the drug under FDA’s Animal Rule that permits non-human primate efficacy and safety studies for conditional approval as phase I human trials proceed."
RESEARCH TRIANGLE PARK, N.C., Aug. 29, 2014 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that the National Institute of Allergy and Infectious Diseases (NIAID) has awarded a contract modification for an additional $2.4 million to BioCryst to conduct a dose ranging efficacy study of an intramuscular formulation of BCX4430 in non-human primates as a treatment for Ebola virus disease. The study is expected to be initiated within weeks.
The successful completion of an efficacy study in an experimental Ebola virus disease model in non-human primates represents an important next step towards understanding the potential of BCX4430 as a treatment for Ebola disease in humans. NIAID, part of the National Institutes of Health, granted a contract to BioCryst in September 2013 valued up to $22.0 million over five years. With this additional award, the BCX4430 development contract has been increased in value to $24.4 million, if all options are exercised.
3 drugs with FDA input in the coming months. HAE normally would / should be the biggest event but now the ebola story may overtake it for the short term.
HAE ph2b pivotal designation
4430 human safety trial
"Think about the combinations of animals feeding on corpses in the street that died from Ebola. The probability of mutation is real."
There's also an illegal bushmeat market here in the US that could bring ebola to the US.
Keep in mind, all of us could be contagious to ebola. Let's hope the odds are nil for an H2H mutation like flu, but even with a small chance exactly what importance do you think world Govts. are looking at this situation???
"For starters, the data show that the virus is rapidly accumulating new mutations as it spreads through people. "We've found over 250 mutations that are changing in real time as we're watching."
While moving through the human population in West Africa, she says, the virus has been collecting mutations about twice as quickly as did while circulating in animals for the last decade or so.
"The more time you give a virus to mutate and the more human-to-human transmission you see," she says, "the more opportunities you give it to fall upon some [mutation] that could make it more easily transmissible or more pathogenic."
Ebola Outbreak Strains Sequenced (excerpt)
Source: Swineflu magazine
"Clearly this virus is evolving, but what's not clear is whether or not the mutations it's accumulating affect the way it behaves."
But he said there was no evidence at present that the virus was changing its behaviour and becoming better adapted to humans.
Seriously, they better get moving quickly on finding the best drug.
Comments from May transcript (thx Yui)
...very good efficacy and safety in high attack rate patients. Something DYAX nor Cinryze trials have attempted to treat on their own. This can't be stressed enough.
Marcus Maurer MD - principal investigator with the study:
"The more severe the disease, the harder it is to reduce the disease activity. With patients who have less severe and less frequent attacks it’s easier to provide protection (Cinryze trial). So my guess is that in the clinics or in future trials that we’ll see even better protection rate of protection from attacks using 4161."
"Significant reduction similar to what we’ve seen with Cinryze. I think it will translate in the clinics to an even better protection.”
“The benefit that you see in this type of study with more severely affected patients becomes even stronger with more mildly affected patients.” Eligibility will be opened up to allow lower attack rate patients in the next trial.
3 high attack rate subjects had 0 attacks throughout the 4161 span. 0 subjects accomplished this on placebo.
TKMR, not sure yet about them. BCRX is the sleeping giant with 4430 and ready to be awaken next week at Geneva.
Let's get that IND filed and human safety trial going ASAP!
Expect updates on 4430 and how it will play into the current ebola epidemic. Possibly next week.
WHO says Ebola outbreak could strike 20,000 people
Reuters 2 hr ago By Stephanie Nebehay of Reuters
GENEVA (Reuters) - The current Ebola outbreak in West Africa could infect more than 20,000 people, the World Health Organisation (WHO) said on Thursday in a bleak assessment of the deadly disease.
The United Nations health agency issued a strategic plan to combat the outbreak in four West African nations where it said the actual number of cases could already be two to four times higher than the reported 3,069. The death toll stands at 1,552.
"This roadmap assumes that in many areas of intense transmission the actual number of cases may be 2-4 fold higher than that currently reported. It acknowledges that the aggregate case load of Ebola Virus Disease could exceed 20,000 over the course of this emergency," the WHO said
3,000 infected as of today's numbers....~7 x worse in 6-9 months. NOT GOOD.
Next week BCRX goes to Geneva and presents 4430 to this elite board of experts.
Long shelf life at ambient temperatures
Easy to administer...this is why I think they went with the IM over IV
Effective when administered after the onset of disease
Safe (preclinical has shown this drug likely be safe)
Broad Spectrum: BCRX represents a compound with broad spectrum potential
Ebola story is not over...6 months expected to resolution. BCRX may get an approved drug sooner than later on 4430.
"Issues of safety and efficacy will be discussed together with innovative models for expediting clinical trials. Possible ways to ramp up production of the most promising products will also be explored."
Tweets from a Nigerian Dr. around Aug. 8th.
Bello Bello Katagum
Chemical Structure Of #BCX4430 AKA The "Secret Serum" .. CC Prof. Iwu
Setting Up A Research Facility For A Possible #BCX4430 Is A Promising Option. It's Time Our Pharm/Researchers Get To Work.
from the 10-Q: " the Company does not currently expect an event of default on the PhaRMA Notes to have a significant impact on the Company’s future results of operations or cash flows."
this is not a stinky fart...hah.
Good catch. This was presented at the 2nd Antivirals Congress in 2012 however it doesn't appear that it was ever published in a journal (that I can find) which is the reason for confusion.
BCRX wants this information out there: "The authors have paid a fee to allow immediate free access to this article"
My note: Besides results of 4430 on hamsters, ***THIS IS WHAT THEY WANT TO BE SEEN IMO***
71 Ideally, a compound
72 developed for the treatment of YF would be stable with a long shelf life at
73 ambient temperature, easy to administer, effective when administered after the
74 onset of clinically evident disease, and safe. From a logistical standpoint, it would
75 also be advantageous if such a drug had broad-spectrum activity against other
76 viral hemorrhagic fever (VHF) pathogens, precluding the need to develop and
77 supply multiple therapeutic agents that treat only a single etiologic agent of VHF.
78 RNA viruses, including other members of the Flaviviridae virus family related to
79 YFV, such as West Nile virus or dengue virus, may share common replication
80 pathways and similar pathogenic mechanisms. Thus, a drug that targets a
81 common replication pathway could result in an effective treatment for a wide
82 range of viruses.
83 The novel adenosine analog BCX4430 represents a compound with such broad-
84 spectrum potential