First Wave announces RESERVOIR recommendation

Rising or Falling

Boca Raton, Florida-based First Wave BioPharma, Inc., a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases,  announced on November 30 that an independent data monitoring committee (DMC) has recommended that enrollment continue in Part 2 of the ongoing RESERVOIR Phase 2 trial evaluating FW-COV as a treatment for COVID-19-related gastrointestinal (GI) infections. FW-COV is a proprietary, oral, tablet formulation of micronized niclosamide developed to remove SARS-CoV-2 (SARS2), the virus that causes COVID-19, from the GI tract.

The recommendation was based on a review of the safety data collected from the first 25 patients enrolled in Part 2 of the RESERVOIR trial. Data review uncovered no safety issues. Part 2 of the study is expected to enroll as many as 150 patients.

RESERVOIR, a two-part, two-arm, randomized, placebo-controlled Phase 2 study, is attempting to confirm the safety of FW-COV and assess the drug’s ability to remove the SARS-CoV-2 (SARS2) virus from the digestive tract. Patients are randomized to receive either niclosamide or a placebo treatment for 14 days. After that, patients stop treatment but remain under observation for as long as 6 weeks, with additional follow-up observations at 4 and 6 months to assess persistence or recurrence of symptoms. The efficacy of FW-COV is measured by the rate of SARS2 clearance from stool samples assessed by PCR test, comparing the niclosamide arm and the placebo arm. Long-term observation could indicate whether niclosamide treatment has the potential to prevent “long haul” COVID-19 symptoms.

The company was formerly known as AzurRx BioPharma, Inc. It changed its name to First Wave BioPharma, Inc. in September 2021.

According to James Sapirstein, president and chief executive officer of First Wave BioPharma, “The DMC’s review of interim safety data was very positive with no substantive safety issues documented in the initial 25 patients dosed in Part 2 of the RESERVOIR trial. This news comes at a critical time in the COVID-19 pandemic with the rise of the fast-spreading Omicron variant. Because niclosamide targets the entire virus, and not just the spike protein, we believe that FW-COV may prove effective against multiple strains of COVID-19 and may provide an effective therapeutic to help millions of COVID-19 patients overcome the debilitating and often overlooked effect the virus can have on the GI system. Based on current timelines and pacing of enrollment, which is strong, we expect to report topline results from the RESERVOIR trial next year, including an assessment of FW-COV’s ability to clear the COVID-19 virus from the GI tract.”

James Pennington, M.D., chief medical officer of First Wave, added, “Despite vaccination campaigns and booster shots, COVID-19 and its growing family of dangerous variants continue to spread, and the virus’ lingering effects have developed into a major medical issue for millions of people. Research suggests SARS2 may form reservoirs in the GI tract and cause illness long after the abatement of the initial infection. Early data demonstrated that our micronized oral niclosamide therapy is well tolerated, and we believe that FW-COV may have the ability to remove these viral reservoirs from the GI tract, adding a much needed drug to the COVID treatment regimen.”

Gastrointestinal infection symptoms, such as severe diarrhea, vomiting and abdominal pain, have been reported in approximately 18 percent of COVID-19 cases, and it is estimated that about 43 percent of all COVID patients may have the virus present in their GI tracts. Of the 48 million individuals who are reported to have contracted COVID-19 in the U.S., this would translate into over 8 million patients having GI infection with symptoms. Of the 260 million cases reported globally, it would translate into almost 47 million patients with GI infection symptoms. Furthermore, about 10 percent of patients who were infected with COVID have persistent symptoms months after their initial diagnosis. About 86 percent of these COVID “long haulers” are reported to have GI infection symptoms, with 60 percent continuing to have diarrhea months after their initial infection. Some evidence supports the view that the GI tract is a possible reservoir for recurrence and fecal spread of the COVID-19 virus as ACE-2, the entry receptor for COVID-19, is highly expressed on GI cells. There currently is no targeted treatment for COVID GI infections.

Niclosamide, a prescription small molecule drug listed as an essential medicine by the World Health Organization (WHO), has been safely used on millions of patients for other clinical indications. In the U.S., niclosamide was approved by the U.S. Food and Drug Administration (FDA) in 1982 for the treatment of intestinal tapeworm infections. In addition to its antihelminthic activity, niclosamide has demonstrated anti-inflammatory and anti-viral properties. There remains an urgent need to develop new medicines that can be manufactured at large scale quickly to treat COVID-19.

Two additional formulations of niclosamide, FW-UC (ulcerative colitis) and FW-CD (Crohn's disease) are focused to enter into pipeline development. The company is also advancing FW-EPI (adrulipase) for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis and chronic pancreatitis. 

Shares of First Wave rocketed 46.6 percent on very heavy volume in premarket trading November 30, after the company revealed the news. Trading volume spiked to 12 million shares ahead of the open, enough to make the stock the most actively traded in the premarket, and compared with the full-day average of about 1.4 million shares, according to MarketWatch. The stock, which underwent a 1-for-10 reverse stock split in September, and closed at a split-adjusted record low of $1.86 on November 23, had plunged 68.5 percent over the past three months prior to the announcement.

Some analysts say that the stock is in the middle of a very wide and falling trend in the short term and is likely to fall further. In view of the current short-term trend, the stock could fall as much as -64.41 percent during the next 3 months and have a share price between $0.24 and $0.58 at the end of this 3-month period. If the stock price manages to stay at current levels or higher, the prediction could change for the better. Several analysts call the stock a strong buy, believing the company will be profitable by 2024. In the short term, First Wave’s annual earnings growth rate is not forecast to beat the U.S. biotechnology industry's average forecast earnings growth rate.