dm+d

Unassigned

New Medicines

HIV infection treatment and prevention - in combination with current Anti Retroviral Therapy (ART)

Information

New molecular entity
CytoDyn
CytoDyn

Development and Regulatory status

None
None
Phase III Clinical Trials
Oct 20The MHRA has cleared CytoDyn to file its BLA for leronlimab as a combination therapy for multi-drug resistance HIV pts in the UK. The clearance included a treatment regimen of 1 x 350mg injection/week as contrasted to the dosing regimen used in the PIII trial of 2 x consecutive injections of 175mg/week. CytoDyn announced plans to complete filing 'very soon' as well as working towards a label expansion for monotherapy in UK. [15]
Sep 20 CytoDyn is in talks with FDA regarding resubmission of its Biologic License Application (BLA) for leronlimab. [16,17]
Jul 20The FDA rejected filing application for leronlimab due to missing information. In a refusal-to-file letter, the FDA state that the application “does not contain certain information needed to complete a substantive review”. Cytodyn have committed to providing the information as soon as possible and have confirmed that further trials are not needed.[14]
Jan 20The first section (non-clinical) of the Biological License Application (BLA) under the FDAs rolling review process has been submitted. CytoDyn indicate on website that work is underway to complete the submission.[11]
Jan 19On company pipeline (PIII).[7] Investor presentation suggests company plans for submission of marketing authorisations in Q1 2019.[8]
Feb 18Company pipeline indicates in PIII trials.[6]
Dec 15PRO 140 has been designated a "fast track" product candidate by the FDA [2,3].
Dec 15PRO 140 has finished PII clinical trials with demonstrated antiviral activity in man and is currently in PIII trials which are due to complete in 2017 [2-4].
Aug 15CytoDyn completed an end -of-PIIb meeting with the US FDA following which they indicated that they might seek for accelerated approval. The company expects to apply for breakthrough designation for PRO 140 monotherapy, as a component of HAART, in pts with HIV 15 [2,3].

Category

Fully humanised IgH4 monoclonal antibody of CCR5 receptor. Potently blocks the HIV co-receptor, CCR5, on T-cells, preventing viral entry into T-cells [2,3]
In 2017, ~ 84,725 people in England were living with HIV and 78,000 were aware of their infection. Of these, 90% are treated and 3% fail to achieve viral suppression following treatment which indicates multi-drug resistance. The prevalence of CCR5 tropic HIV infection is ~70% so it is estimated that overall, around 1470 adults in England (2-3 per 100,000 people in England) would be eligible for this. [12]
HIV infection treatment and prevention - in combination with current Anti Retroviral Therapy (ART)
Subcutaneous and
Intravenous

Trial or other data

Oct 18New class of HIV/AIDS therapeutics called viral-entry inhibitors that are intended to protect healthy cells from viral infection. Could be used as monotherapy to allow pts to rotate off their HAART regimens for several months. PRO 140 has potentially fewer side effects and less frequent dosing requirements as compared to daily drug therapies currently in use [3].
Feb 18Results from a one-week, randomised, double-blind mutlicentre, placebo-controlled PIIb/III trial (n=52) showed significant reduction in HIV-1 RNA viral load of >0.5log from baseline vs. pts in placebo arm (p0.5log reduction in HIV-1 RNA viral load from baseline.[5]
Oct 15The US FDA accepted a protocol submitted by CytoDyn in May 2014, to conduct a 25-week PIII trial in 300 pts with HIV in the US. The primary end point of the trial is to reduce the viral load in HIV pts, who have experienced a viral load breakout, by 0.7log (a 5-fold drop) in one week with one 350mg dose of PRO 140 [2,3].
Jun 15CytoDyn reported that PRO 140 is in PIII development as a component of HAART (highly active antiretroviral therapy) in pts with HIV infections (PRO140CD02; NCT02483078) [2,3].