The Cleveland Clinic and Dr. Daniel J. Lindner, MD, PhD will collaborate with microcap biotech CyoDyn (OTC.QB: CYDY) to study its investigational CCR5 antagonist leronlimab (PRO 140) for its ability to prevent Non-Alcoholic Steatohepatitis (NASH) in humanized murine (mice) models. TrialSite News has written on the imminent NASH crisis. As Pfizer’s Maraviroc HIV drug has been the subject of several positive comparable studies CytoDyn seeks to consider the opportunities.
The CCR5 pathway evidences potential promise in addressing NASH. Leronlimab, a highly selective CCR5 inhibitor, in over 700 patients thus far has not exhibited hepatotoxicity associated with other CCR5 antagonists. Moreover, CyoDyn speculates that leronlimab may provide less frequent dosing and has the interesting potential to be used as a monotherapy or synergistically with other molecular compounds.
Dr. Linder on NASH
“Nash is a quickly growing global epidemic without an approved treatment in the U.S.,” and “we have successfully developed humanized murine NASH models and look forward to determining if leronlimab can offer potential breakthroughs in NASH inhibition.”
NASH is liver inflammation and damage caused by buildup of fat in the liver. Many people have buildup of fat in the liver, and for most people it causes no symptoms. However, as reported by the NASH Education Project, up to 25.2% of the adult population may have NAFLD and the prevalence of NASH is expected to increase to 63% between 2015 and 2030. NASH is now on pace to become the leading cause of liver transplantation in the U.S. by 2020.
Success will Lead to IND & Protocol for Phase 2 Trial
Dr. Nader Pourhassan, PhD, President and CEO of CytoDyn touts, “a successful proof-of-concept study of leronlimab in NASH will allow the company to immediately file with the FDA and IND and protocol for Phase 2 trial, as we have done with other indications.” Moreover, he noted, “we are encouraged by Pfizer’s (Maraviroc) results in this field and we look forward to sharing the results of our study as soon as it is available.”
About Leronlimab (PRO 140)
The investigational drug has been granted FDA Fast Track designation as a combination therapy with HAART for HIV-infected patients, and for metastatic triple-negative cancer. It is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor metastases and immune signaling. It has successfully completed phase 1/2/3 clinical trials in 700 people, including a successful pivotal Phase 3 trial in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients.
A biotech company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of HIV to enter and infect healthy T-cells. It also appears to implicate in tumor metastasis and in immune-mediated illnesses, such as graft vs. host disease (GvHD) and NASH.
It has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a BLA in 2019 for that indication. The industry sponsor is currently conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients, and plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, could support a label extension.
Based in Vancouver, WA, CytoDyn is traded as a microcap valued today at $145.3 million (stock value at .45 per share). They lost approximately $52 million last year. Only about 13% of the stock is held by insiders according to Yahoo Finance. CytoDyn represents a thinly capitalized structure and will need continuous capital raise offerings for commercial success—risk is high.