“There are currently no approved therapies for N
Post# of 154320
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Posted On: 08/15/2022 6:46:21 PM
“There are currently no approved therapies for NASH and current HAART regimens often contribute to hepatoxicity. Patients with HIV and NASH represent an unmet medical need, and we believe leronlimab may play a vital role in this population of patients to reduce HIV viral load, steatosis, and fibro-inflammation. We are currently focused on the following potential strategies:
1. Strengthening our pharmacovigilance program enabling us to remove the FDA clinical holds placed on our HIV and COVID-19 programs to allow us to conduct future clinical studies.
2. Advancing our NASH program to a Phase 2b or Phase 2b/3 trial for steatosis and liver fibrosis associated with NASH.
3. Exploring a study for patients with HIV and NASH.
4. Contining our Phase 2 program for metastatic triple-negative breast cancer with current standard of care, explore a Phase 2 colon cancer trial with current standard of care, and explore other solid tumor indications.
[[Colon cancer seems to be mentioned again. Interesting.
Then continuing mTNBC….Do we want more data before we bring a phase 3 proposal to the FDA ? Maybe that’s why we are waiting till September maybe we can file for BTD by then with the additional data that is due in September?]]
5. Continuing our work to evaluate the feasibility and timelines for the HIV BLA resubmission and explore other cancer and immunologic indications for leronlimab, continue our work on developing a long-acting version of leronlimab, and pursue proof of concept studies for HIV cure using leronlimab and AAV vectors.
6. Reviewing our strategy for our COVID-19 program.”
No mentions of partnerships as far as strategy. Strange. Maybe this is just checking the box information and nothing concrete.
1. Strengthening our pharmacovigilance program enabling us to remove the FDA clinical holds placed on our HIV and COVID-19 programs to allow us to conduct future clinical studies.
2. Advancing our NASH program to a Phase 2b or Phase 2b/3 trial for steatosis and liver fibrosis associated with NASH.
3. Exploring a study for patients with HIV and NASH.
4. Contining our Phase 2 program for metastatic triple-negative breast cancer with current standard of care, explore a Phase 2 colon cancer trial with current standard of care, and explore other solid tumor indications.
[[Colon cancer seems to be mentioned again. Interesting.
Then continuing mTNBC….Do we want more data before we bring a phase 3 proposal to the FDA ? Maybe that’s why we are waiting till September maybe we can file for BTD by then with the additional data that is due in September?]]
5. Continuing our work to evaluate the feasibility and timelines for the HIV BLA resubmission and explore other cancer and immunologic indications for leronlimab, continue our work on developing a long-acting version of leronlimab, and pursue proof of concept studies for HIV cure using leronlimab and AAV vectors.
6. Reviewing our strategy for our COVID-19 program.”
No mentions of partnerships as far as strategy. Strange. Maybe this is just checking the box information and nothing concrete.
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