FWIW, this is my two minute elevator pitch to total newbies:
Big pharma has done great with vaccines but done nothing to help the really sick, those with full-face oxygen masks or tubes down their throat. This is the “cytokine storm” phase of the disease, when an over-active immune system, rather than viral replication, is causing morbidity and mortality.
Fortunately, 4 small bios* have filled randomized, blinded “Phase 3 Registrational Trials” for those patients. Barring safety issues, if the trials show statistical significance, this should be enough data for full FDA approval.
Leronlimab, by Cytodyn. had its last patient/last visit on January 13th, so read out could be any day. Their 400-patient “trial of the sickest” is the only one to finish its trial exactly as it was begun, retaining “28-day mortality” as its endpoint. The other trials were modified by their “data safety monitoring committees” to add more patients or weaken their endpoints.
Within a week of the study’s end, the FDA authorized the trial centers to offer leronlimab for all patients fitting the trial’s conditions, and allowed any US doctor to request emergency use for such patients. Enticingly, Medicare documentation already has a payment code for the drug.
This is the third of four Covid-related data sets for leronlimab. First was a non-randomized collection of 60 emergency IND patients, indicating a rough 50% reduction in deaths versus comparable groups. This triggered a quick, small, Phase 2 trial for mild/moderate patients and the more extensive severe/critical Phase 3 trial mentioned above.
The Phase 2 trial showed surprising significance in reducing the UK’s “national early warning score,” which captures the risk of deteriorating to severe disease, along with a significant 63% reduction in severe adverse events. The fourth dataset is to come: the FDA has approved leronlimab for the first “long haulers” trial - first injections are next week.
Leronlimab blockades a receptor called “CCR5” on the immune system’s T-cells, so they don’t sense the siren call of inflammatory attractors - specifically "RANTES" - that are over-recruiting immune cells to the lungs and other organs in Covid. It is in use in HIV, where it blocks entry of the virus into immune cells, and is being tested in cancer, where it appears to block metastases. It is an extra-ordinarily safe drug.
* Leronlimab by CytoDyn, Lenzilimab by Humanigen, RLF-100 by Relief Therapeutics, and SACCOVID by OncoImmune
Big pharma has done great with vaccines but done nothing to help the really sick, those with full-face oxygen masks or tubes down their throat. This is the “cytokine storm” phase of the disease, when an over-active immune system, rather than viral replication, is causing morbidity and mortality.
Fortunately, 4 small bios* have filled randomized, blinded “Phase 3 Registrational Trials” for those patients. Barring safety issues, if the trials show statistical significance, this should be enough data for full FDA approval.
Leronlimab, by Cytodyn. had its last patient/last visit on January 13th, so read out could be any day. Their 400-patient “trial of the sickest” is the only one to finish its trial exactly as it was begun, retaining “28-day mortality” as its endpoint. The other trials were modified by their “data safety monitoring committees” to add more patients or weaken their endpoints.
Within a week of the study’s end, the FDA authorized the trial centers to offer leronlimab for all patients fitting the trial’s conditions, and allowed any US doctor to request emergency use for such patients. Enticingly, Medicare documentation already has a payment code for the drug.
This is the third of four Covid-related data sets for leronlimab. First was a non-randomized collection of 60 emergency IND patients, indicating a rough 50% reduction in deaths versus comparable groups. This triggered a quick, small, Phase 2 trial for mild/moderate patients and the more extensive severe/critical Phase 3 trial mentioned above.
The Phase 2 trial showed surprising significance in reducing the UK’s “national early warning score,” which captures the risk of deteriorating to severe disease, along with a significant 63% reduction in severe adverse events. The fourth dataset is to come: the FDA has approved leronlimab for the first “long haulers” trial - first injections are next week.
Leronlimab blockades a receptor called “CCR5” on the immune system’s T-cells, so they don’t sense the siren call of inflammatory attractors - specifically "RANTES" - that are over-recruiting immune cells to the lungs and other organs in Covid. It is in use in HIV, where it blocks entry of the virus into immune cells, and is being tested in cancer, where it appears to block metastases. It is an extra-ordinarily safe drug.
* Leronlimab by CytoDyn, Lenzilimab by Humanigen, RLF-100 by Relief Therapeutics, and SACCOVID by OncoImmune
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