CytoDyn Inc. (CYDY) Requests FDA Breakthrough Therapy Designation for HIV-1 Treatment

Biotech company CytoDyn Inc. (OTCQB: CYDY) this morning announced that it has filed a request with the U.S. FDA for Breakthrough Therapy Designation for its lead product candidate, PRO 140, as a treatment for HIV-1 infection in treatment-experienced patients with virologic failure.

The request stems from limitations with the current standard of care for HIV infection, which features a combination of medications from numerous antiretroviral classes that are known to interfere with individual steps of the HIV lifecycle. As the virus multiplies within the body, it sometimes mutates, producing variations of itself with drug-resistant characteristics that can limit the effectiveness of existing treatment options. As a result, a significant number of long-term survivors are currently faced with issues of drug resistance, requiring new treatment options and creating a sizable unmet need in the HIV treatment market. CytoDyn is taking aim at this unmet need through the ongoing development of PRO 140 for HIV-1 patients with uncontrolled viral load, despite conventional antiretroviral therapy.

To-date, PRO 140 has completed Phase 2 clinical trials and is currently in Phase 3. Results from a total of seven Phase 1 and Phase 2 human clinical trials have shown PRO 140 effective in significantly reducing viral burden in individuals living with HIV. By filing for Breakthrough Therapy Designation, CytoDyn will seek expedition of the biologics license application (BLA) process for PRO 140 ahead of commercialization.

“Investigators from several sites have requested continued access to PRO 140 to allow patients to continue deriving clinical benefit and maintain HIV-1 viral suppression after the end of treatment in the CD02 Phase 3 Combination Therapy study,” Dr. Nader Pourhassan, president and CEO of CytoDyn, stated in this morning’s news release. “Seven patients have entered the rollover study to receive continued access to PRO 140 after the completion of the 25-week treatment period in this study. Additionally, 10 patients in the ongoing Phase 2b extension arm of Monotherapy trial have shown suppressed viral load for two years.  We believe PRO 140 has demonstrated its value as a combination therapy and as a single agent in patients with the R5 strain of HIV and are hopeful that receiving Breakthrough Therapy Designation will speed our BLA process to get this product to the market.”

While statistics relating to drug resistance in HIV patients are limited, data from the Centers for Disease Control and Prevention (CDC) gives some insight into the scope of the issue. The CDC estimates that roughly 10 percent of people with HIV in the United States – about 120,000 Americans – are unable to maintain an undetectable viral load despite being on antiretroviral therapy. Poor adherence to treatment regimens and extended treatment interruption likely play a role in some of these cases, but many of these individuals have developed a drug-resistant strain of HIV for which there is currently no approved treatment option.

For more information, visit www.CytoDyn.com

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