CytoDyn Inc. (OTCQB: CYDY) is set to profit from helping the HIV positive with its lead product candidate, PRO 140. The company is close to submitting a rolling Biologics License Application (BLA) for PRO 140 as a combination therapy with highly active antiretroviral therapy (HAART).
The biologic has already been designated a “fast track” product candidate by the FDA, and, earlier this month, the company filed a request for Breakthrough Therapy Designation with the FDA for PRO 140 as a treatment for HIV-1 infection in treatment-experienced patients with virologic failure. Getting PRO 140 to market means CytoDyn Inc. will be entering the $15 billion industry for HIV therapies in the U.S.
Data released by the National HIV Surveillance System and Medical Monitoring Project reveals the market opportunities. There are an estimated 1.2 million people in the U.S. living with HIV. However, about 168,000 of those, some 14 percent of those infected, are unaware that they are HIV positive. The remaining 1,032,000 know they have the virus, yet just 40 percent (480,000) are under care.
Why this is so has prompted a number of studies. Researchers in the European Union and Australia conducted a number of surveys of the HIV positive and the doctors who treat them. They found that the major reason why those carrying HIV eschew treatment is that they do not feel sufficiently unwell or have symptoms serious enough to hasten entry to treatment. The studies also revealed ‘that 47% of respondents did not wish to start therapy because they did not want to be reminded about their HIV status’.
Of the 480,000 HIV positive patients who are being treated, about 92.5 percent, or 444,000, have been prescribed antiretroviral therapies. Meanwhile, just 360,000, or 75 percent of the HIV positive population under care, have been able to achieve viral suppression.
PRO 140 has the greatest potential as a mono-therapy, if replacing HAART as a first-line or higher therapy. This is a market of 460,000 people estimated at $11 billion. As a combination therapy replacing second line therapy and higher, the prospect is also attractive. With 207,000 patients falling into this segment, this is a market that could yield over $5 billion. In addition, as the stigma of HIV/AIDS lessens, it is likely that more of the HIV positive will be encouraged to start treatment, bringing over half-a-million into the fold.
PRO 140 is a viral-entry inhibitor, a new class of HIV/AIDS therapies that work by blocking the entry of the human immunodeficiency virus (HIV) to healthy cells. It is currently being evaluated in two Phase III trials and, in one of those, a pivotal Phase III trial testing PRO 140 as a combination therapy, primary endpoint results are expected during the first half of this year.
The second Phase III trial, testing PRO 140 as a mono-therapy, is also going well. The company announced in December 2016 that the first patients had been treated in a multi-center, open-label trial. For the HIV positive, this is positive news from CytoDyn Inc.
CytoDyn is a biotechnology company focused on the clinical development and potential commercialization of humanized monoclonal antibodies for the treatment and prevention of HIV infection. In trials, its lead product candidate, PRO 140, has shown it can significantly reduce viral burden in those infected with HIV. CytoDyn intends to continue to develop PRO 140 as a therapeutic anti-viral agent in persons infected with HIV and to pursue non-HIV indications where similar autoimmune responses are involved.
For more information, visit www.CytoDyn.com
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