Corbus Pharmaceuticals Gets New Stock Coverage, FDA Trial Approval, and Grant from the Cystic Fibrosis Foundation

Everybody’s favorite no cannabis cannabis company has three pieces of good news to close out January 2018. Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) is continuing its long-term steady progress toward approved drug status.

Stock Coverage by Raymond James

Raymond James Financial began coverage on shares of Corbus Pharmaceuticals with a research report issued on Friday, January 19th, 2018. The firm’s financial researchers are giving the stock an initial “outperform” rating with a $24.00 price target. The biopharmaceutical company’s price target indicates a potential upside of approximately 250 percent from the stock’s current trading range.

Other financial analysts already follow Corbus. Raymond James’s decision to initiate coverage is significant as Raymond James Financial provides middle America with personalized services through a nationwide network of offices.

Their one-on-one advisors may bring more individual investors to Corbus’s stock. Greater holdings by small investors tend to add stability to a company’s long-term market pricing.

FDA Approves Phase 2B Trial for Lenabasum

Corbus Pharmaceuticals announced that it has an agreement with the U.S. Food and Drug Administration on the design of its next study of the lenabasum pro-resolving drug, in the treatment of cystic fibrosis. The FDA will instead evaluate Corbus’s drug, Lenabasum, based on its ability to reduce disease flare-ups.

Typically, companies were required to demonstrate an improvement in lung function as measured by forced expiratory volume in one second, or FEV1. This change will dramatically cut the cost and time necessary to develop the drug.

The FDA also agreed to the inclusion of adolescents 12-17 years of age alongside adults in the Phase 2b study. The Company expects the first patient to start the program during this quarter.

"Pulmonary exacerbations are a key driver of morbidity and mortality in cystic fibrosis," said Barbara White, M.D., Chief Medical Officer of Corbus. "We now have agreement from the FDA that the event rate of pulmonary exacerbations is an acceptable primary efficacy outcome in the clinical development program to support registration of lenabasum for the treatment of CF. The FDA's input underscores the importance of new treatments that reduce the number of pulmonary exacerbations. With about 415 patients treated for 6-months, the next Phase 2 study is large enough and long enough to potentially provide statistically significant data regarding the benefit of lenabasum in pulmonary exacerbations in CF."

Yuval Cohen, Ph.D., Chief Executive Officer of Corbus, added, "The outcome of our meeting with the FDA represents a very significant milestone for our CF development program and builds on the foundation provided by the clinical data from our previous Phase 2 study. Lenabasum is the first pro-resolving drug to be tested for efficacy in CF and the first experimental therapeutic to be tested in CF patients with the event rate of pulmonary exacerbation as the sole primary efficacy endpoint, without a requirement from the FDA to consider FEV1% as a co-primary endpoint. We look forward to working closely with the stakeholders within the CF community on successfully executing this first of its kind trial."

The Cystic Fibrosis Foundation Awards Corbus a $25 Million Development Grant

The award will support a 415-patient, 6-month Phase 2b study designed to provide clear evidence of clinical benefit for people with CF. Lenabasum’s prior Phase 2 study was supported by the CF Foundation through a $5 million Development Award.

"We believe this award highlights the potential for lenabasum to serve as an important therapy for people living with CF by targeting a critical unmet need in all CF patients. We are grateful to the CF Foundation for expanding its support for our CF clinical program, including our Phase 2b clinical development program in which the event rate of pulmonary exacerbations will be the primary efficacy endpoint," commented Yuval Cohen, Ph.D., CEO of Corbus.

"People with CF and their physicians understand the need to reduce pulmonary exacerbations, a major driver of disease burden. New treatments are essential, given most adolescent and adult patients have at least one episode per year. Lenabasum showed promising efficacy against pulmonary exacerbations in a previous 85-subject Phase 2 study and we look forward to getting a more definitive answer about lenabasum's beneficial impact on reducing pulmonary exacerbations in high-risk patients in the upcoming study," added James Chmiel, M.D., M.P.H., co-principal investigator of the Phase 2b study and specialist in pediatric pulmonary diseases at the LeRoy W. Matthews Cystic Fibrosis Center at University Hospitals Rainbow Babies & Children's Hospital.

The study will be conducted at approximately 100 sites across North America, Europe, Israel, and Australia. Subjects will be centrally randomized to one of three regimens of lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day for 28 weeks. The Company expects to complete the study by the end of 2019.

Lenabasum was granted Orphan Drug Designation and Fast Track status for the treatment of CF by the FDA in 2015 and Orphan Drug Status from the European Medicines Agency in 2016.

What is Lenabasum?

Lenabasum is a synthetic, oral, small-molecule, selective cannabinoid receptor type 2 (CB2) agonist that preferentially binds to CB2 expressed on activated immune cells and fibroblasts. CB2 activation triggers physiologic pathways that resolve inflammation, speed bacterial clearance and halt fibrosis. CB2 activation also induces the production of specialized pro-resolving lipid mediators that activate an endogenous cascade responsible for the resolution of inflammation and fibrosis, while reducing production of multiple inflammatory mediators.

Through activation of CB2, lenabasum also is designed to have a direct effect on fibroblasts of halting tissue scarring. Lenabasum is believed to induce resolution rather than immunosuppression by triggering biological pathways to turn "off" chronic inflammation and fibrotic processes.

If you want a simpler explanation of lenabasum, watch the video on the corporate website.

The No Cannabis Cannabis Drug

Nowhere in the above portions of this article is anything said about lenabasum being derived from cannabis.

Nothing is said regarding lenabasum being a synthetic form of THC, CBD, or any other cannabinoid.

The closest thing to anything to do with cannabis is that the drug binds to CB2 receptors. CBD binds to the same receptor but so do several other substances. This does not make lenabasum a form of CBD.

Every article you have read saying Corbus is making a synthetic form of THC is wrong.

Every article you have read saying Corbus’s stock could be damaged by Jeff Sessions’ war on marijuana is wrong.

Not enough for you? Visit the website for Corbus Pharmaceuticals and search for any scrap of cannabis language.  

The closest you will come is this phrase: “Lenabasum is a novel, synthetic oral endocannabinoid-mimetic drug designed to resolve chronic inflammation and fibrotic processes.”

Endocannabinoid-mimetic drug does not mean lenabasum is a cannabinoid.

When you consume cannabis, the cannabinoids in the plant interfere with and overwhelm the natural endocannabinoids in the body throwing the entire system off balance.

Even though you have two substances that interact with the same neurotransmitter system, it does not make them the same thing.

Kale and a chocolate shake both interact with the digestive system, but kale is not a dessert.

Why is Corbus Considered a Cannabis Stock?

Good question.

Once upon a time, someone writing an article made the wrong assumption about endocannabinoids and cannabinoids. The falsehood spread under the principle of everything on the internet is true.

The company does not deny the connection as the cannabis industry hype helps raise their stock price which makes it easier to raise the capital necessary to bring a new drug to market.

Everyone wants to see seriously ill people get relief.

Final Thoughts

The best reason for considering Corbus as an investment is not in this article.

Lenabasum is in stage three clinical trials for the treatment of systemic sclerosis. Positive results in this test could start a low 10-figure revenue stream in two to three years.

 

CRBP is currently trading at $6.93.

The author has no direct investment in CRBP. The author may have an indirect interest in CRBP through ownership of shares in the Horizons Marijuana Life Index ETF (TSX:HMMJ).

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