It is worth to note that in the 10-Q CytoDyn presents the investigational Mono trial as 2/3.
Somebody posted the possibility of going towards approval more rapidly.
Well, the answer is in maroon above
.
If FDA takes the trial as P2/3 as pivotal we are very close:
Enrollment for this trial is now closed after reaching 565 patients. This trial assesses the subcutaneous use of leronlimab as a long-acting single agent maintenance therapy for 48 weeks in patients with suppressed viral load with CCR5-tropic HIV-1 infection. The primary endpoint is the proportion of participants with a suppressed viral load to those who experienced virologic failure. The secondary endpoint is the length of time to virologic failure. The trial evaluates three dosage arms, 350 mg, 525 mg and 700 mg. We recently reported that interim data suggested that both the 525 mg and the 700 mg dosages are achieving a responder rate of approximately 90% after the initial 10 weeks. Some of the data from this trial is also being used to provide safety data for the BLA filing for leronlimab as a combination therapy. In view of the high responder rate at the increased dosage levels, coupled with the newly developed CCR5 receptor occupancy test, we recently filed a pivotal trial protocol with the FDA for leronlimab as a monotherapy. We are discussing finalization of that protocol with FDA and could initiate the Phase 3 trial in the first quarter of 2020. Upon finalization with the FDA of the pivotal trial protocol for monotherapy, the Phase 2b/3 investigative trial will likely be discontinued.
1) The primary endpoint is the proportion of participants with a suppressed viral load to those who experienced virologic failure: We recently reported that interim data suggested that both the 525 mg and the 700 mg dosages are achieving a responder rate of approximately 90% after the initial 10 weeks.
Approximately 30% of subjects fail within the first 10 weeks of monotherapy on a 525 mg dosage and 17% at a dosage of 700 mg. Those patients who pass the first 10 weeks of monotherapy on a 525 mg dose have reached an average total of 32 weeks with sustained viral load suppression.
2) The secondary endpoint is the length of time to virologic failure: Currently, there are four patients in this ongoing extension study and each has surpassed five years of suppressed viral load with leronlimab as a single agent therapy. This extension study will be discontinued upon any FDA approval of leronlimab as combination therapy for HIV.
50 patients in 350 mg dose arm have reached more than 1 year of monotherapy.
In addressing the initial virologic failure (only 17% with 700 mg) Dr. Patterson tests will determine most effective dose for each HIV monotherapy patient to achieve viral suppression. (receptor density-occupancy test) that will improve this number.
Now, Phase 2A is specifically designed to determine dosage, Phase 2B to determine efficacy. I would think we have done that with flying colors.
Definition of pivotal Trial below:
Pivotal Clinical Trial means (a) a Phase III Trial or, (b) a Phase II Trial to the extent: (i) in the United States, the protocol for that Phase II Trial shall have been reviewed by the FDA under its current Special Protocol Assessment Guidelines (or equivalent guidelines issued in the future), and any comments from the FDA on that protocol are incorporated in the final protocol for that Phase II Trial or are resolved to the FDA’s satisfaction as evidenced by further written communications from the FDA; or (ii) a process with a comparable result – acceptance of a Phase II Trial protocol as “potentially pivotal” – has occurred with the EMA or other Regulatory Authorities in the EU; or (iii) based on the results of that Phase II Trial, either the FDA or the EMA has determined that the Phase II Trial can be considered as a pivotal clinical trial for purposes of obtaining Regulatory Approval.
I submit that we have already have an acceptable number of patients treated (565) with demonstrated safety and efficacy. FDA should accept Phase 2/3 trial as pivotal trial and approve Leronlimab for Mono pronto!!
Somebody posted the possibility of going towards approval more rapidly.
Well, the answer is in maroon above
.
If FDA takes the trial as P2/3 as pivotal we are very close:
Enrollment for this trial is now closed after reaching 565 patients. This trial assesses the subcutaneous use of leronlimab as a long-acting single agent maintenance therapy for 48 weeks in patients with suppressed viral load with CCR5-tropic HIV-1 infection. The primary endpoint is the proportion of participants with a suppressed viral load to those who experienced virologic failure. The secondary endpoint is the length of time to virologic failure. The trial evaluates three dosage arms, 350 mg, 525 mg and 700 mg. We recently reported that interim data suggested that both the 525 mg and the 700 mg dosages are achieving a responder rate of approximately 90% after the initial 10 weeks. Some of the data from this trial is also being used to provide safety data for the BLA filing for leronlimab as a combination therapy. In view of the high responder rate at the increased dosage levels, coupled with the newly developed CCR5 receptor occupancy test, we recently filed a pivotal trial protocol with the FDA for leronlimab as a monotherapy. We are discussing finalization of that protocol with FDA and could initiate the Phase 3 trial in the first quarter of 2020. Upon finalization with the FDA of the pivotal trial protocol for monotherapy, the Phase 2b/3 investigative trial will likely be discontinued.
1) The primary endpoint is the proportion of participants with a suppressed viral load to those who experienced virologic failure: We recently reported that interim data suggested that both the 525 mg and the 700 mg dosages are achieving a responder rate of approximately 90% after the initial 10 weeks.
Approximately 30% of subjects fail within the first 10 weeks of monotherapy on a 525 mg dosage and 17% at a dosage of 700 mg. Those patients who pass the first 10 weeks of monotherapy on a 525 mg dose have reached an average total of 32 weeks with sustained viral load suppression.
2) The secondary endpoint is the length of time to virologic failure: Currently, there are four patients in this ongoing extension study and each has surpassed five years of suppressed viral load with leronlimab as a single agent therapy. This extension study will be discontinued upon any FDA approval of leronlimab as combination therapy for HIV.
50 patients in 350 mg dose arm have reached more than 1 year of monotherapy.
In addressing the initial virologic failure (only 17% with 700 mg) Dr. Patterson tests will determine most effective dose for each HIV monotherapy patient to achieve viral suppression. (receptor density-occupancy test) that will improve this number.
Now, Phase 2A is specifically designed to determine dosage, Phase 2B to determine efficacy. I would think we have done that with flying colors.
Definition of pivotal Trial below:
Pivotal Clinical Trial means (a) a Phase III Trial or, (b) a Phase II Trial to the extent: (i) in the United States, the protocol for that Phase II Trial shall have been reviewed by the FDA under its current Special Protocol Assessment Guidelines (or equivalent guidelines issued in the future), and any comments from the FDA on that protocol are incorporated in the final protocol for that Phase II Trial or are resolved to the FDA’s satisfaction as evidenced by further written communications from the FDA; or (ii) a process with a comparable result – acceptance of a Phase II Trial protocol as “potentially pivotal” – has occurred with the EMA or other Regulatory Authorities in the EU; or (iii) based on the results of that Phase II Trial, either the FDA or the EMA has determined that the Phase II Trial can be considered as a pivotal clinical trial for purposes of obtaining Regulatory Approval.
I submit that we have already have an acceptable number of patients treated (565) with demonstrated safety and efficacy. FDA should accept Phase 2/3 trial as pivotal trial and approve Leronlimab for Mono pronto!!
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