For a look into what the future of Brilacidin deve
Post# of 72440
Posted On: 11/19/2013 9:30:50 AM
For a look into what the future of Brilacidin development may hold, look no further than this excellent deck put together by PYMX not long ago. It all but lays out the strategy to move forward.
I highly recommend any current or potential CTIX shareholder give this 36 page powerpoint presentation a good read :
http://files.shareholder.com/downloads/ABEA-4...tation.pdf
Most relevant and eye opening slides to me are:
Slide 21 Detailing Brilacidin ABSSSI Phase 2a results:
Efficacy:
• High clinical response rates
• Similar across all treatment groups (95% CIs overlap)
• Efficacy comparable to active control (daptomycin)
• Early & sustained clinical response
• Rigorous study entry criteria, using FDA definitions for ABSSSI
• Results suggest potential efficacy at lower doses and shorter courses
Safety:
• Brilacidin is safe and generally well-tolerated
• Other than expected numbness & tingling, consistently low TRAE’s
Phase 2b dose-finding study planned
Slide 22 - FDA Support!:
Regulatory Clarity
Recent meeting with FDA to discuss U.S. Phase 2b doseoptimization
clinical trial in ABSSSI patients
Provided FDA with Phase 2b protocol and PK/PD data to
support shorter and lower brilacidin dosing regimens
• FDA support for treating ABSSSI caused by both Staph and Strep
• FDA support for proposed single-dose and three-day dosing regimens
Plans to initiate Phase 2b in 2013
Slide 23 ABSSSI 2B protocol:
Phase 2B ABSSSI Trial - Planned Protocol
Randomized, active controlled, efficacy and safety evaluation of three shorter dosing regimens of brilacidin for ABSSSI caused by Staphylococcus aureus or Streptococcus pyogenes (Group A Strep )
200 patients (50 per group)
Endpoints: clinical success bounded by 95% confidence intervals
Primary population: Intent-to-Treat (ITT)
Primary analysis: early clinical response measured at 48-72 hrs of treatment
Brilacidin dosing: once daily i.v. infusion over 60 minutes for -
a) 3 days (0.6 mg/kg day 1 + 0.3 mg/kg days 2-3) followed by 4 days of once
daily placebo (normal saline); or
b) 1 day (0.6 mg/kg) followed by 6 days of once daily placebo; or
c) 1 day (0.8 mg/kg) followed by 6 days of once daily placebo;
Active comparator: daptomycin (7 days)
Slide 32 Oral Mucositis Protocol:
Phase 2 Oral Mucositis – Planned Protocol
Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled
Control and prevent oral mucositis in patients with Head and Neck Cancer
receiving chemotherapy and radiation therapy
“Swish and spit” brilacidin 3x/daily for 7 weeks – 15 ml oral mouthwash
60 patients – 30 each of drug or placebo
Primary endpoint: proportion of patients with clinically observed severe
ulcerative mucositis (WHO grade > 2) at a cumulative radiation dose of 55 Gy
Secondary endpoints: health resource use/pharmacoeconomics; mouth soreness
Additional dose regimen possible
When you look at the scope of what it will take to get these trials done from start to finish, it is "easy" when compared to what we are going through with kevetrin. (not to say the clinical trials are easy, just comparing between the long and time consuming K trial VS the polar opposite B trials which will be days and not months)
We've got a great drug here that we already know is safe and well tolerated, already has been dosed in hundreds of patients and been efficacious, and we have 2 trials that by all accounts should be quite rapid and show some very impressive results. Just look at the photos on the deck, the stuff WORKS!
All we need is one big or mid level sized pharma today to see this potential. I think many of us assume someone like a Roche or another real big player would be our most likely partner, but I think a mid-size pharma is more likely, someone that wants to make a statement and make an aggressive play in the space.
Come on Leo, you can do this. Another transformational change for CTIX in the making. Share price will follow.
I highly recommend any current or potential CTIX shareholder give this 36 page powerpoint presentation a good read :
http://files.shareholder.com/downloads/ABEA-4...tation.pdf
Most relevant and eye opening slides to me are:
Slide 21 Detailing Brilacidin ABSSSI Phase 2a results:
Efficacy:
• High clinical response rates
• Similar across all treatment groups (95% CIs overlap)
• Efficacy comparable to active control (daptomycin)
• Early & sustained clinical response
• Rigorous study entry criteria, using FDA definitions for ABSSSI
• Results suggest potential efficacy at lower doses and shorter courses
Safety:
• Brilacidin is safe and generally well-tolerated
• Other than expected numbness & tingling, consistently low TRAE’s
Phase 2b dose-finding study planned
Slide 22 - FDA Support!:
Regulatory Clarity
Recent meeting with FDA to discuss U.S. Phase 2b doseoptimization
clinical trial in ABSSSI patients
Provided FDA with Phase 2b protocol and PK/PD data to
support shorter and lower brilacidin dosing regimens
• FDA support for treating ABSSSI caused by both Staph and Strep
• FDA support for proposed single-dose and three-day dosing regimens
Plans to initiate Phase 2b in 2013
Slide 23 ABSSSI 2B protocol:
Phase 2B ABSSSI Trial - Planned Protocol
Randomized, active controlled, efficacy and safety evaluation of three shorter dosing regimens of brilacidin for ABSSSI caused by Staphylococcus aureus or Streptococcus pyogenes (Group A Strep )
200 patients (50 per group)
Endpoints: clinical success bounded by 95% confidence intervals
Primary population: Intent-to-Treat (ITT)
Primary analysis: early clinical response measured at 48-72 hrs of treatment
Brilacidin dosing: once daily i.v. infusion over 60 minutes for -
a) 3 days (0.6 mg/kg day 1 + 0.3 mg/kg days 2-3) followed by 4 days of once
daily placebo (normal saline); or
b) 1 day (0.6 mg/kg) followed by 6 days of once daily placebo; or
c) 1 day (0.8 mg/kg) followed by 6 days of once daily placebo;
Active comparator: daptomycin (7 days)
Slide 32 Oral Mucositis Protocol:
Phase 2 Oral Mucositis – Planned Protocol
Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled
Control and prevent oral mucositis in patients with Head and Neck Cancer
receiving chemotherapy and radiation therapy
“Swish and spit” brilacidin 3x/daily for 7 weeks – 15 ml oral mouthwash
60 patients – 30 each of drug or placebo
Primary endpoint: proportion of patients with clinically observed severe
ulcerative mucositis (WHO grade > 2) at a cumulative radiation dose of 55 Gy
Secondary endpoints: health resource use/pharmacoeconomics; mouth soreness
Additional dose regimen possible
When you look at the scope of what it will take to get these trials done from start to finish, it is "easy" when compared to what we are going through with kevetrin. (not to say the clinical trials are easy, just comparing between the long and time consuming K trial VS the polar opposite B trials which will be days and not months)
We've got a great drug here that we already know is safe and well tolerated, already has been dosed in hundreds of patients and been efficacious, and we have 2 trials that by all accounts should be quite rapid and show some very impressive results. Just look at the photos on the deck, the stuff WORKS!
All we need is one big or mid level sized pharma today to see this potential. I think many of us assume someone like a Roche or another real big player would be our most likely partner, but I think a mid-size pharma is more likely, someone that wants to make a statement and make an aggressive play in the space.
Come on Leo, you can do this. Another transformational change for CTIX in the making. Share price will follow.
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