December 13, 2021 07:00 ET | Source: First Wave BioPharma, Inc. First Wave BioPharma, Inc.
Boca Raton, Florida, U.S.
Boca Raton, Florida, December 13, 2021 (Global News Service)--First Wave BioPharma, Inc., (NASDAQ: FWBI), ("First Wave BioPharma" or "Company"), A clinical-stage biopharmaceutical company specializing in the development of targeted non-systemic therapies for gastrointestinal (GI) diseases, today announced that James Sapirstein, Chairman, President and Chief Executive Officer of First Wave BioPharma, has agreed to the company’s 2021 shareholder The annual meeting sent a letter to shareholders so that it will be held at 9 a.m. Eastern Time on December 17, 2021. This letter provides an update on recent events and prospects for the company's clinical projects in 2022.
The full text of the letter is as follows.
Message from our Chairman and CEO
First Wave BioPharma is a transforming company, and I am writing to you today, as excited about our future as since becoming CEO in 2019.
Two major events provided the end of the book for an extraordinary year for our company. In January, as AzurRx BioPharma, we signed an exclusive global license agreement with First Wave Bio, Inc. for the treatment of COVID-19-related gastrointestinal infections and immune checkpoint inhibitor-related colitis (ICI-Communications). Eight months later, in September 2021, we completed the acquisition of First Wave Bio, which included a patented and proprietary formulation of niclosamide for other indications for inflammatory bowel disease (IBD), including ulcers Proctitis (UP), Ulcerative Colitis (UC) and Crohn’s Disease. Subsequently, we changed the company’s name to better align with our new IBD assets and opportunities, including changing our company name Changed to "First Wave BioPharma" and started trading our common stock under the new stock symbol "FWBI" on NASDAQ.
In the process of 2021, we have transformed from a company with a single asset Adrulipase and two clinical projects to a company with two assets and five new clinical-stage projects, including three for multi-billion dollar clonazepine The commercial market for the saliamine project IBD. In order to highlight this potential, we are investigating the phase 2 clinical trial of the main candidate drug FW-COV based on niclosamide in COVID-19-related gastrointestinal infections. The number of registrations continues to increase. We recently launched FW- UP Clinical Program We conducted our first clinical trial in IBD. This is a phase 2a study that evaluated the safety of niclosamide in ulcerative proctitis (UP) and ulcerative rectal sigmoid colitis (UPS) And effectiveness, this is the most common form of ulcerative colitis (UC).
To support this growth, we strengthened our clinical operations, supervision, quality assurance, and manufacturing teams, added new members to the board of directors and scientific advisory committee, and strengthened our capital position. In 2021, we completed the financial transactions that have raised approximately US$48 million so far and reorganized the payment terms for the combined consideration of First Wave Bio, thereby freeing up funds to fund our ongoing clinical trials.
The new year is approaching, and we look forward to 2022 with excitement. Our priorities for the coming year have been determined, and we are ready to achieve several key milestones. I am happy to share with you more detailed information about the work done and the work we are about to plan to achieve.
First Wave BioPharma – clinical opportunities for six GI indications with a multi-billion dollar commercial market
We built a pipeline around two intestinal restrictive GI technologies-Niclosamide, a small molecule with antiviral and anti-inflammatory properties, and adrulipase, a recombinant lipase designed to help digest fat and other nutrients substance. We now have development and clinical stage projects covering six GI indications with significant market-scale opportunities, including: COVID-19-related GI infections (estimated at US$10 billion for COVID-19-related antiviral drugs); Ulcerative colitis, ulcerative proctitis, and ulcerative proctosigmoiditis (estimated value of 5 billion U.S. dollars); Crohn's disease (estimated value of 7.4 billion U.S. dollars); immune checkpoint inhibitor-associated colitis (immune checkpoint inhibitor) Estimated value of 22 billion U.S. dollars); and exocrine pancreatic insufficiency (EPI), a dangerous digestive system disease that plagues most patients with cystic fibrosis and chronic pancreatitis (estimated value of 1.6 billion U.S. dollars).
Looking forward to 2022, our focus is on advancing three phase 2 clinical phase projects. We hope to achieve near-term clinical and regulatory milestones in these projects, including FW-COV, a niclosalin used for COVID-related gastrointestinal infections. Amine oral tablet preparation; FW-UP, an external preparation of niclosamide for ulcerative proctitis; finally, FW-EPI, an oral biocapsule preparation of Addu lipase for exocrine pancreatic insufficiency.
Niclosamide-a potential game changer in the treatment of IBD
The core of the acquisition of First Wave Bio is that we see great opportunities for non-systemic, non-immunosuppressive oral and topical niclosamide therapy for IBD. These are huge, fast-growing commercial markets with significant unmet medical needs. In the United States last year, it is estimated that there were more than 825,000 UC diagnoses and 625,000 Crohn's disease (CD) diagnoses, and these numbers are expected to increase to 850,000 and 810,000, respectively, by 2026. However, despite the large and growing number of patients, there have been few recent innovations to address the increasing demand for new drugs or the limitations and challenges associated with currently available treatments, including steroids, 5-ASA, JAK inhibitors, and biologics.
We entered the IBD field in October, when we administered the first patient in a phase 2a clinical trial, which was designed to evaluate the effects of niclosamide on UP and UPS, two forms of ulcerative colitis, and a chronic The safety and effectiveness of patients with inflammatory bowel disease (IBD) attacks the lower large intestine (colon and rectum). Patients are being recruited at clinical trial sites in Italy, and we expect to add more trial sites in Austria and Germany, and complete recruitment in the first half of 2022.
Our optimism about niclosamide in the FW-UP program and other IBD indications is based on our positive phase 1b UP data, which for the first time proves the principle of niclosamide in the treatment of IBD. In addition, Niclosamide was listed as an essential drug by the World Health Organization and was approved by the FDA in 1982 for the treatment of intestinal tapeworm infections. It has been safely used by millions of patients. Studies have shown that Niclosamide can also selectively target disease-causing cells in the digestive tract, including Th17 immune cells that infiltrate the intestines of patients with IBD.
We believe that Niclosamide can prevent or delay the progression of IBD, prevent sudden onsets, and meet the needs of patients at all stages of the disease (from mild to severe) without the risk of immunosuppression. In addition, Niclosamide is a small molecule drug that can be administered without the use of a needle, usually in the form of oral tablets, and is a highly targeted drug designed to solve the inflammation that causes the disease Area of the gastrointestinal tract. By doing so, our Niclosamide products have the potential to avoid systemic complications usually associated with steroids and other immunosuppressive agents.
The decision to prioritize the FW-UP clinical program over ICI-AC is part of a well-thought-out strategy that uses the UP and UPS indications as a stepping stone into the wider IBD market. This strategy is based on two factors. First of all, our other IBD assets UC and CD have not yet entered the clinic, and we have completed the early clinical trials of UP and UPS. Second, these tests of UP and UPS provided positive safety and effectiveness data. Niclosamide is well tolerated when administered in low and high doses. In addition, in the preliminary data of the first 17 patients in a phase 1a trial that treated patients at a low dose (150 mg/twice a day), the drug showed a long-lasting therapeutic effect and a clinical remission rate of 59%, much higher than 38 % According to reports, the commonly used steroid budesonide has a remission rate of 44%. This data marks the first evidence of niclosamide as a principle for the treatment of IBD. If the additional data from our ongoing high-dose phase 2a trial continues to support the safety and effectiveness of the drug in UP and UPS, we believe we There will be a strong foundation for extending our clinical activities to other larger IBD indications. This in turn should attract cooperation opportunities and ultimately create shareholder value.
Niclosamide-a new oral antiviral therapy to fight COVID-19
Our optimism towards Niclosamide further strengthens our latest progress in the clinical program for COVID-19-related gastrointestinal infections. The Phase 2 RESERVOIR trial aims to evaluate the safety and effectiveness of niclosamide oral preparations, and started to be administered to patients in June. This marks an important milestone in our global struggle to develop new therapies for COVID-19. With the rise of highly contagious variants of Omicron, the COVID-19 pandemic continues despite the global vaccine measures.
Like many others in the biopharmaceutical industry, we believe that COVID-19 will eventually become epidemic. Overcoming the virus requires antiviral therapy that is safe for everyone, effective in mild to moderate cases, and easy to administer.
FW-COV is designed to remove the SARS-CoV-2 virus from the gastrointestinal tract. Studies have shown that the virus can hide in the gastrointestinal tract, cause infection, and may cause long-term gastrointestinal damage and fecal transmission of the virus. About 18% of COVID-19 patients have gastrointestinal symptoms, and about 43% of COVID-19 patients have a virus in their gastrointestinal tract. There is currently no treatment available for the treatment of COVID-19-related gastrointestinal infections. Since Niclosamide targets the entire virus, not just the spike protein, we believe that FW-COV may prove effective against multiple COVID-19 strains, including Delta and Omicron variants. In addition, long-term observation can indicate whether niclosamide has the potential to prevent "long-term" COVID-19 symptoms.
An independent data monitoring committee has twice reviewed the early safety data of the second phase RESERVOIR trial and found no safety issues. The trial has entered the second phase of safety and effectiveness, with plans to recruit up to 150 patients at 23 trial sites in the United States, India, and Ukraine. Based on the current timetable and strong entry rhythm, we expect to report RESERVOIR's top-line results in the first half of 2022, including an assessment of the ability of FW-COV to clear the COVID-19 virus from the gastrointestinal tract.
Adrulipase – Towards a safer non-animal-derived EPI therapy
Earlier this year, we reported the top-line data from two phase 2 clinical trials of Adrulipase-one is the Phase 2b OPTION 2 trial, which evaluated the drug as a monotherapy for EPI inpatients with cystic fibrosis, and the other evaluated adrulipase and the current standard of care, pancreatic enzyme replacement therapy (PERT). The phase 2 combination trial of 20 patients has achieved significant success. The data showed a clinically significant improvement in the coefficient of fat absorption (CFA) (the primary efficacy endpoint), indicating that the combination therapy may benefit patients with cystic fibrosis with severe EPI.
The top-line results for Option 2 were mixed. Although the drug has proven its safety and tolerability, and clearly demonstrated its activity, the trial has not always met the primary efficacy endpoint for all patients. We believe that the root cause of the uneven efficacy of the drug is that the enteric-coated capsule formula used for drug delivery causes the drug to dissolve in the small intestine too slowly, and the lipase cannot be released in time to help proper digestion and nutrient absorption.
We are focused on advancing the development of a new formulation of Adrulipase, which we believe will prove to be the best choice as a monotherapy. To this end, our manufacturing team has been developing capsules containing acid-resistant particles, similar to those used in our commercial competitors CREON®, ZENPEP® and other porcine pancreatin replacement (PERT) therapies. The capsule dissolves in the stomach, disperses the particles, and then enters the small intestine, where the particles break down and release lipase so that they can be thoroughly mixed with food during digestion. Our goal is to complete the formulation work in the first quarter of 2022 and initiate a phase 2b trial in the second half of 2022 to evaluate this new formulation clinically.
The key to the Adrulipase program is that we believe that the drug provides a key advantage over PERT and has the potential to replace it as a standard of care. EPI is an enzyme deficiency that makes it difficult for patients to digest fat and absorb the nutrients needed to maintain a healthy weight and growth. For many cystic fibrosis patients, lung function is good. In the United States alone, the market value of EPI is estimated at $1.6 billion, including more than 30,000 cystic fibrosis patients and another 90,000 chronic pancreatitis patients.
PERT drugs are made from porcine pancreas, which poses challenges for manufacturing. The pigs on which PERT depends may be affected by infections, including swine flu. Many cystic fibrosis patients are concerned about pig-based products. In addition, the "pill burden" of PERT is daunting. Patients may take more than 25-40 large PERT capsules a day to control their symptoms, but almost one-third of cystic fibrosis patients cannot use PERT to control their EPI, and the dose cannot be increased for safety reasons. In contrast, adrulipase has the potential for safety and well tolerability, does not contain any animal products, and is made from highly abundant resources, can be safely produced in large quantities on demand, and has a high degree of repeatability.
We still believe that Adrulipase has strong potential to attract cooperation opportunities and licensing interest from large pharmaceutical companies.
Capital resources-prioritize planning, reduce expenditures and reach clinical milestones
First Wave BioPharma has sufficient funds to fund our clinical strategy by achieving our near-term clinical goals. In 2021, we raised approximately US$48 million in total proceeds through the sale of preferred and common shares in public offerings and private equity transactions and the exercise of warrants. In the fourth quarter of 2021, we raised approximately $10.5 million in total proceeds from “on-the-field” (ATM) sales, which provides us with a cash runway through the second quarter of 2022, at which time we expect to announce the completion of our Two phase 2 clinical trials of COVID-19-related gastrointestinal infections and UP are ongoing, and phase 2 trials of new adrulipase new formulations have begun. We plan to continue to raise funds in the most efficient and cost-effective manner as needed, minimize dilution, and provide financial resources to advance our clinical projects and achieve expected milestones.
To further strengthen our capital resources is the successful negotiation with First Wave Bio to modify the payment structure of the initial acquisition consideration. According to the initial terms of the acquisition, we prepaid US$3 million in cash to First Wave Bio and issued 624,025 common stocks worth US$4 million. The remaining USD 15 million advance payment will be paid in two instalments in October 2021 and March 2022, but has been reorganized into smaller monthly instalments until 2023. The reorganization of these payments provided us with additional financial resources to achieve our major clinical milestones-the completion of our ongoing two phase 2 niclosamide clinical trials and the development of Adrulipase formulations.
This has been a difficult year for biotech stocks, with many stock prices falling, including First Wave BioPharma, especially in the second half of 2021. In fact, SPDR S&P Biotech ETF (XBI) is an equal-weighted index of biotech stocks that has fallen by about 18% so far this year, while the S&P 500 has gained 25%, which is down from its peak on February 8, 2021. 33%.
As shareholders of the company, our team was also frustrated and disappointed with the decline in stock prices during the year. We believe that our stock price does not reflect the value of our assets and the development stages of multiple Phase 2 clinical projects. We focus on wisely managing our cash expenditures and reserves, and prioritize clinical projects with near-term, high-impact milestones.
Despite the current market turmoil, we believe that 2022 is an optimistic year for First Wave BioPharma, which is based on our pipeline strength and the countless value creation opportunities that we expect to realize soon. I look forward to working with my management team and other board members to implement a business and clinical strategy that has the potential to build First Wave BioPharma into a gastrointestinal treatment powerhouse and create value for shareholders.
In every aspect, our mission is the same-to provide relief to patients who live with the pain, danger and discomfort inherent in gastrointestinal diseases every day, protect their health and restore their quality of life. We look forward to embarking on what we consider to be fruitful 2022, and we thank you for your continued support.
Sincerely, James Sapirstein Chairman, President and CEO First Wave BioPharma, Inc.
First Wave BioPharma, Inc. Annual Meeting of Shareholders
First Wave BioPharma, Inc.’s annual shareholder meeting will be held at 9:00 AM Eastern Time on December 17, 2021. The virtual address is: www.virtualshareholdermeeting.com/FWBI2021. The board of directors unanimously recommended that shareholders vote for all the proposals on the agenda.
About First Wave BioPharma, Inc.
First Wave BioPharma, Inc. is a clinical-stage biopharmaceutical company that specializes in the development of targeted non-systemic therapies for gastrointestinal (GI) diseases. The company is currently advancing a therapeutic development pipeline, which includes multiple clinical-stage projects built around its two proprietary technologies-Niclosamide, an oral small molecule with antiviral and anti-inflammatory properties, and biological Addu Lipase, a recombinant lipase, is designed to enable the digestion of fats and other nutrients. First Wave BioPharma’s niclosamide product portfolio is led by two clinical projects in phase II clinical trials: FW-COV for COVID-19 gastrointestinal infections and FW-UP for ulcerative proctitis (UP) And ulcerative rectosigmoid colitis. The other three indications of niclosamide include FW-ICI-AC, which is used to treat patients with advanced tumors in the treatment of grade 1 and 2 immune checkpoint inhibitor-related colitis and diarrhea, FW-UC (ulcerative colitis) and FW-CD (Crohn's disease). The company is also advancing FW-EPI (adrulipase) for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. First Wave BioPharma is headquartered in Boca Raton, Florida. For more information, please visit www.firstwavebio.com.
This press release may contain certain forward-looking statements related to future results. The company’s actual results and financial conditions may differ materially from the expected results and financial conditions indicated in these forward-looking statements, depending on whether the results obtained in preclinical and non-clinical studies and clinical trials are indicative. Factors: the results obtained in future clinical trials; whether the preliminary or interim results of clinical trials will represent the final results of the trial; the potential market size of the company’s drug candidates and their ability to serve these markets; the acquisition of First Wave Bio, Inc. and its The impact of the announcement on the company’s business, operating results and financial prospects; the integration of First Wave Bio, Inc.’s business with the company’s own business; and the company’s current and future capital needs and its ability to raise additional funds to meet its capital needs. For other information about the company and its business, including discussions on factors that may have a significant impact on the company’s financial performance, please refer to the company’s annual report on Form 10-K for the year ended December 31, 2020, titled "Risk Factors, "And the company's subsequent documents submitted to the US Securities and Exchange Commission. All forward-looking statements contained in this press release are made only on the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect subsequent events or circumstances that occur or that we will be aware of in the future.
For more information: First Wave BioPharma, Inc. 777 Yamato Road, Suite 502 Boca Raton, FL 33431 Tel: (561) 589-7020 info@firstwavebio.com
Media Contact: Tiberend Strategic Advisors, Inc. David Schemelia (609) 468-9325 dschemelia@tiberend.com