New Synthetic Antiviral Drug Approves for ability to Treat HIV Anywhere on Cost
LAS VEGAS A new synthetic version of the antiviral drug serving as a target for treating HIVAIDS is approved for large-scale human use by the Institute of Medicine (Intramural Research ProgrammePROPPO) in partnership with the non-profit ACTRAIDS. The liquid-like compound intravital protease inhibitor or LPEI for short plays an important role in inhibiting replication of HIV which play a key role in the disease. However LPEI is priced at more than 10000 per vial.
The co-lead implementation iterations of the product are now available under a non-exclusive license to other intramural in vitro therapy providers who are working alongside intramural in vitro patients providing rapid access to this lifesaving drug. Over 2 million people worldwide have been treated with LPEI since it was first licensed for use against contracting HIV in 2010.
The challenge in treating HIV is that it is over-stimulated to overwhelm the hosts immune system in the form of an overactive immune response to infection. LPEI acts by acting on a receptor on the surface of HIV cells that is overactive stopping the HIV entry says Target Pharmaceuticals CEO and Chief Scientific Officer Jeffrey van Loo. LPEI was viewed as a promising HIV treatment due to its promising antiviral capabilities.
In a phase 3b clinical trial performed on adults LPEI achieved remission of SIV-associated latency and enhanced viral loadunleukemia as measured by RNA viral load and levels of proinflammatory cytokines. The Phase 3b trial showed 16-hour and 72-hour clinical efficacy against HIV-infection respectively in 21 rural geographically dispersed cohorts spanning 12 sites in Uganda South Africa Russia the Democratic Republic of the Congo and Uganda. In contrast to the clinical trial results they showed no significant differences in viral load or levels of pro-inflammatory cytokines in patients who were not treated with LPEI in the trial.
This latest incarnation of this drug has the potential to be a breakthrough as it targets a specific mechanistic target which is seen in the LPEI license. LPEI is a molecular target for all HIV strains as well as several other herpes viruses van Loo says. We believe LPEI has the potential longevity of the drug while meeting multiple clinical needs.
Visceral covered by insurance and publicly funded facilities like the NIHs National Institute of Allergy and Infectious Diseases launched the phase 3b trial of LPEI in MSM aged 16 to 59 years at 16 sites that include TrialLink an intramural HIV treatment service in Portland Oregon. TrialLink has a population-level user base of almost 40000 people. About 80 are asymptomatic meaning there was no detecting the virus. About 10 are symptomatic meaning they showed symptoms or did not show clinical signs of disease after the trial started.
In the trial participants showed an increase in viral load but did not require supplemental antiretroviral therapy and 20 showed viral clearance levels above 80. No significant differences in pro-inflammatory cytokines were found between the placebo and LPEI groups apart from those seen in participants who are over 60 years old and those who are smokers. Prohibited cytokines included AXL (cytokine receptor alpha) IL1B1 (interleukin-1) and IL5 (interleukin-5) were identified in patients treated with LPEI van Loo says.
The market for LPEI has been rapidly expanding owing to several strategy investments by Target Pharmaceuticals. The company ended 2018 with 193 million in sales up 20 year-on-year. Target Pharmaceuticals has experimented with various licensing as well as buyout acquisition and distribution strategies for LPEI products using an early stage research study that evaluated first product candidates and then the broader potential for LPEI. Target hopes to eventually begin a mass patient registration campaign to demonstrate that LPEIv2. 0 is safe and well-tolerated.