First Wave BioPharma, Inc., (NASDAQ: FWBI) stock is getting bid higher after announcing adrulipase, its product candidate for treating exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP), was identified having an enhanced enteric microgranule drug delivery profile. That data does more than support its use in FWBI's ongoing development of its FW- EPI clinical program; it's likely to keep the bullish trend intact.
It's provided an excellent start. Since the announcement, FWBI shares have increased by about 16%, decoupling from market weakness that has sharply decreased biotech company valuations during the past week. Still, while an appreciable gain, the better news is that it could be the precursor of more to come, supported by FWBI saying it intends to submit an Investigational New Drug (IND) application for a Phase 2 "proof-of-concept" clinical study evaluating the improved formulation to potentially treat specific types of EPI.
Even better for those liking to trade ahead of potential catalysts, FWBI said that upon FDA approval, it's prepared to commence that trial before the end of 2022.
Good For FWBI, Excellent For Investors
FWBI is optimistic that will be the case. And good news for FWBI could be excellent news for investors, especially those taking advantage of that milestone, plus riding the momentum inherent to FWBI reigniting its adrulipase development program.
The invigorated program will add to data showing adrulipase's impressive treatment potential for EPI associated with CF and CP, which in earlier clinical trials demonstrated an excellent safety profile and a mechanism of action that should enable a therapeutic benefit. While its prior formulation resulted in an inconsistent dispersal of adrulipase in the gastrointestinal tract, this new in vitro formulation shows compelling differences, with the latest in vitro enteric microgranule drug delivery formulation of adrulipase outperforming prior drug versions.
Data suggest the new formulation's delayed-release profile should protect adrulipase in the stomach and enable it to be delivered to the targeted areas of the GI tract where it can mix with food in the duodenum to provide its therapeutic effect. FWBI believes the data indicate that the new formulation of adrulipase will result in consistent coefficient of fat absorption (CFA) values greater than 80%, with 80% and higher the recognized threshold for achieving therapeutic benefit in patients with EPI associated with CF and CP. There's more good news.
Replacing A 40-Pill Per Day Regiment
Research further indicates that the enhanced adrulipase formulation may significantly decrease the number of pills patients need to take to achieve a desired therapeutic effect. That's a significant advantage, with the pill burden associated with pancreatic enzyme replacement therapy (PERT) as high as 40 capsules per day, creating a substantial challenge to treat EPI due to patient regimen resistance. That advantage alone is more than a critical differentiator for patients; it could help expedite approvals from an FDA sympathetic to patient needs.
Getting that approval is a mission in progress, accelerated by FWBI's strategic decision to direct its near-term resources toward filing its IND application and beginning a Phase 2 clinical trial. With that the case, FWBI stock could decouple further from broad weakness in the biotechnology sector, where company stocks of all sizes have been met with a decidedly bearish sentiment.
The Biotech Bulls Always Look For Value
While that may be the overall mood, investors are still seizing on opportunities, including those presented by undervalued companies with treatment solutions that have the potential to become standard of care. FWBI checks those boxes.
Moreover, with a significantly improved balance sheet, having made significant strides in its clinical development efforts, and advancing a potentially best-in-class treatment option for certain EPI indications, they may be checking many more in the coming weeks. That makes the FWBI value proposition and investment consideration more than attractive; it makes it timely.
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