Why The Corbus Pharmaceuticals Holdings Inc (CRBP) Cystic Fibrosis Results Are Very Positive

Why No Open Label Extension for CF?

Many who follow Corbus closely are aware of the open label extensions granted the company by the FDA in the dermatomyositis and scleroderma indications. That these were granted in itself is evidence of positive efficacy. So why not in CF is well? Is this a bad sign? The answer is that CF already has 9 drugs available and patients can live 20 to 40 years with the disease. The FDA is less generous in granting early stage open label extensions in these cases. This is not the case with either scleroderma or dermatomyositis, which have no medications available and can be fatal much more quickly.

So before investors sell shares in response to what some financial bloggers have viewed as underwhelming and cherrypicked data, it is important to keep in mind two things. First, if these data can be replicated in a larger trial, Anabasum will likely be approved for CF. Second, the scleroderma and dermatomyositis trials, both with open label extensions, are ongoing.

Conclusion

There is a strong correlation between the frequency and amount of pulmonary exacerbations in CF patients and FEV1 decline. If Corbus Pharmaceuticals Holdings Inc (NASDAQ:CRBP) can show a 75% reduction in annualized exacerbations over 2 months, what will likely follow over a longer period of time is an improvement in FEV1. Regardless of how you may interpret the data, speaking just in terms of the actual hard numbers, if they can be replicated in a larger and longer trial, Anabasum will likely be approved for cystic fibrosis.

Note: This article is written by David Rich and originally published at Market Exclusive.