10 Sep CytoDyn – Company files an IND and a Phase 2 Protocol for Treatment of NASH
CytoDyn Inc (OTCQB: CYDY), a clinical stage biotechnology company, announced the filing of an Investigational Drug License (IND) for treatment of NASH with Leronlimab. The drug candidate is a humanized IgG4 mAb CCR5 antagonist that has been granted the Fast Track designation by the FDA for treatment of two indications, as a combination therapy with HAART for HIV-infected patients and for metastatic triple-negative breast cancer (mTNBC).
Furthermore, the company is also filing for a Phase 2 clinical trial protocol based on positive clinical trial data, for evaluating the efficacy of Leronlimab in the treatment of liver fibrosis associated with NASH. The trial has been designed as a multi-center, randomized, double blind, placebo-controlled trial, with a subject size of 60 adult patients with NASH.
Nader Pourhassan, Ph.D., CytoDyn’s President and CEO states
“We are cautiously optimistic about the potential of Leronlimab to provide a new therapeutic option for individuals diagnosed with NASH. We again thank the men and women who have agreed to participate in our trials”
Additionally, the company has also received an approval from the FDA for a Phase 2 protocol, involving a 30-patient study, which tests the efficacy and safety of a combination of injected Leronlimab and Regorafenib taken orally, for treatment of patients with metastatic colorectal cancer.
The company is engaged in pursuing multiple therapeutic indications which could benefit from the use of CCR5 such as HIV, Immunology, Cancer and Prognostics tools.
CytoDyn Inc (OTCQB: CYDY)
Market Cap: $153.74M; Current Share Price: 0.3999USD
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Industry
Nonalcoholic Steatohepatitis (NASH) is a form of Non-Alcoholic Fatty Liver Disease (NAFLD) and is characterized by the build up of FAT in the liver. This condition is marked by hepatitis, inflammation, cell damage and fat deposits in the liver. These fat deposits can cause fibrosis of the liver, in turn leading to liver cancer or cirrhosis.
According to an estimate only 20 percent of the people suffering from NAFLD have NASH, while the rest only have a simple fatty Liver. While nearly 40 percent in the U.S are afflicted with NAFLD, around 3 to 4 percent have NASH. The American Liver foundation estimates that over 100 million people suffer from NAFLD in the U.S alone.
Though the exact cause of the disease is still unknown, NASH often develops from underlying conditions such as obesity and type 2 diabetes, and can affect people of any age. Individuals who have insulin resistance, high triglyceride levels or abnormal cholesterol levels, hypertension and uncontrolled blood glucose are at an increased risk of developing this condition. NASH also increases the chances of developing cardio vascular anomalies and can lead to death from liver-related causes.
The diagnosis usually involves blood tests, use of imaging techniques such as ultrasound, CT scans and MRI, and a liver biopsy. Losing weight through a healthy diet and exercise can help reduce the fat in the liver and is usually the recommended course of action. Currently there are no approved therapies for this condition, with treatment limited to alleviating the symptoms of the condition.
According to a report by Reports and Data, the Global NASH market will be worth over USD 13.38 Billion by 2026. The healthcare costs associated with this disease will likely reach USD 18 billion by 2030 from USD 5 billion now, if the disease is left untreated.
Company
In May 2019, the company announced an agreement with Dr. Daniel Lindner, M.D., Ph.D, of Cleveland Clinic, for testing the efficacy of Leronlimab in preventing the progression of NAFLD into NASH in humanized murine models. CCR5 pathway has been identified as a key pathway in treatment of NASH. Leronlimab is a highly selective CCR5 inhibitor, which has not shown any hepatotoxicity, unlike other CCR5 antagonists. The compound has the potential to be used a monotherapy or in conjunction with other molecules, and offer a lower dosage regimen. Preclinical trials with other CCR5 inhibitors have demonstrated the ability of CCR5 as an anti-inflammatory and anti-fibrotic, which has encouraged the company to pursue NASH as its next therapeutic target.
Dr. Nader Pourhassan, Ph.D., CytoDyn’s President and CEO opines
“We are extremely fortunate and excited to partner with The Cleveland Clinic and Dr. Daniel Lindner to explore the potential of Leronlimab in the prevention of NASH. A successful proof-of-concept study of Leronlimab in NASH will allow the company to immediately file with the FDA an IND and protocol for a Phase 2 trial, as we have done with other indications”.
The company’s lead candidate for the treatment of NASH, Cancer and HIV is Leronlimab (PRO 140), a fully humanized IgG4 monoclonal antibody directed against CCR5 otherwise known as viral-entry inhibitors. This acts by blocking the HIV (R5) subtype entry into T-cells, used by HIV as a molecular portal, and masking the CCR5 co-receptor, but leaving its ability to provide an immune response intact. Though it does not exhibit agonist activity towards CCR5, it has demonstrated antagonist activity to CCL5, a central mediator in inflammatory diseases.
Image Source: Company
So far the company has conducted over 7 clinical trials for Leronlimab (PRO 140) that have proven its ability to reduce HIV viral load in patients, offering minimal side-effects and lower dosages as compared to conventional medicine.
Image Source: Company
In April 2019, CytoDyn announced the topline results from its Phase 2b monotherapy trial. In addition it filed an application for an investigational new drug application (IND) with a Phase 3 protocol for a monotherapy trial with the FDA. The study will be conducted by Amarex Clinical Research, its principal CRO. It is currently engaged in a crucial Phase 3 trial for Leronlimab (PRO 140), as an adjunct therapy to HAART (Highly Active Anti-Retroviral Therapy). Additionally, it has also initiated a Phase 2 trial for treatment of Graft versus Host Disease (GvHD), in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), who are undergoing bone marrow stem cell transplantation. CytoDyn has also received an approval for a Phase 2 protocol in Metastatic Colon Cancer.
It is pursuing 8 cancer indications and NASH and intends to launch preclinical studies in Melanoma, Pancreatic Cancer, Breast, Prostate, Colon, Lung, Liver and Stomach Cancer.
The company also offers Prostate Diagnostic Test (PCa Test), acquired from ProstaGene in November 2018, which offers an improvement over conventional diagnostic tools such as the Gleason score, by applying artificial intelligence to deciphering gene signatures. The PCa test uses 16 gene biomarker signatures for prognostication and therapeutic substratification of prostate cancer using sophisticated proprietary artificial intelligence algorithms, as per the company.
Risk Assessment
- CytoDyn is focusing majorly on the application of PR-140 for the treatment of HIV. The company is upbeat that the product, which is a mono-therapy, can challenge Gilead’s HIV franchise once it hits the markets in 2020. The company pegs it as an $ 11 billion opportunity in the monotherapy maintenance market in HIV alone.
- In April 2019, the company entered into a strategic agreement with Samsung BioLogics Co (207940.KS), for the clinical and commercial manufacturing of Leronlimab (PRO 140). The quantity produced will translate into potential revenues of approximately $1 billion based upon $120,000 per patient, per year as per the company’s estimates, which serves as a validation of its product potential.
- CytoDyn is actively pursuing multiple potential licensing deals and is pushing for speedy commercialization, so that it can gain access to non-dilutive funds to advance it clinical pipeline.
- The company has a diverse pipeline covering varied indications such as HIV, Immunology and Oncology, which mitigates its risk and helps it optimize its capital and resources; however all of these indications are riding on the clinical success of a single drug candidate Leronlimab.
- Clinical trials are unpredictable and are fraught with risk. The company has a lot riding on the success of Leronlimab and will reap benefits if everything goes according to plan, however any setback may severely affect its future prospects.
Conclusion
We believe that the company is poised to achieve success, owing to its approach to development and focus on licensing its pipeline. The areas that the Company is targeting are those with large unmet medical needs and any breakthrough therapy has the potential to be a huge success.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any position within the next 72 hours.
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Source:
https://www.niddk.nih.gov/health-information/liver-disease/nafld-nash/definition-facts
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK),
https://www.the-nash-education-program.com/what-is-nash/key-figures/
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