A self-injectable anti-HIV medication could hit the market as early as 2017. The drug is used to suppress the viral load in HIV patients and is showing a 98% success rate in clinical trials.
If a patient’s viral load is completely suppressed, they are undetectable and the transmission rate of HIV is nearly zero.
PRO 140 has documented an impressive 98% success rate in a Phase 2b clinical trial for patients with HIV. In a monotherapy study, some HIV patients using PRO 140 are experiencing a completely suppressed viral load for 11 months. PRO 140 could be commercial in 2017 if it has positive results from the upcoming Phase 3 trial.
With over 1.2 million individuals already infected in the U.S., and new infections surpassing 50K annually, PRO 140 has received more than $28M in grants from the NIH.
PRO 140 blocks the HIV co-receptor CCR5 on T-cells, preventing viral entry. PRO 140 effectively reduces viral loads by as much as 1.8log with one dose per week. If the HIV patient’s viral load is completely suppressed, the transmission rate becomes almost zero.
For now, the path to first approval for PRO 140 is in the treatment experience population.
Dr. Nader Pourhassan, CytoDyn Inc. President/CEO states, “Results from six Phase 1 and Phase 2 human clinical trials have shown that PRO 140 can significantly reduce viral load in people infected with HIV. Our Phase 3 protocol provides for an upcoming 25-week study with 300 HIV-positive patients. Selection of clinical sites, IRB approvals, patient screening, and other administrative matters are underway and expected to be completed in time for the first patient to be dosed in the third quarter of this year. Although CytoDyn has a green light to start its Phase 3 clinical trial of PRO 140, the Company may apply for a ‘breakthrough’ designation with PRO 140 as the first self-injectable antibody for HIV therapy.”
Phase 3 trials are expected to be conducted at over 30 sites in the U.S. The Company plans to submit its NDA (New Drug Application) for final approval of PRO 140 in November of 2016. PRO 140’s previous fast-track candidate designation carries a possibility of accelerated approval.
