What have been First Wave BioPharma’s main highlights from 2022?

While 2022 was a challenging year for the biotechnology industry, First Wave BioPharma was able to weather the storm. Our primary focus for 2022 was advancing an enteric micro granular formulation of our lead clinical product candidate, adrulipase, in preparation for a planned clinical trial. In December, we filed an IND amendment for a Phase 2 clinical trial to investigate the safety, tolerability, and efficacy of our enhanced formulation in a titrated dose-escalation study involving an estimated twelve patients. The IND was subsequently cleared by the FDA earlier this year, and we are now advancing the trial toward expected topline data by mid-2023.

What are the next steps toward advancing the adrulipase program and what is the market potential?

We are happy to report that we have initiated the Phase 2 SPAN adrulipase clinical and are currently screening patients for the study. The study seeks to determine the safety and efficacy of the new formulation of adrulipase in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency. We anticipate topline data by mid-2023.

The current standard of care for EPI is porcine pancreatic enzyme replacement therapy or PERT. While PERT can be effective at treating EPI, it has several shortcomings that make it challenging for patients. PERT is pig derived, carries a black box warning, and requires patients to take as many as 40 pills per day to achieve a therapeutic effect. We believe that adrulipase, which is recombinant and derived from yeast, has the potential to supplant porcine PERT as the standard of care for EPI associated with CF and chronic pancreatitis (CP).

Where does Niclosamide fit into the unmet need in IBD, and what is First Wave’s strategy to successfully achieve the next milestones for the molecule?

Due to market conditions and financial constraints, we have paused the development of our Phase 2 niclosamide IBD programs in ulcerative colitis and immune checkpoint inhibitor-associated colitis (ICI-AC). That said, we do see the potential for niclosamide as a non-steroidal, non-immunosuppressant anti-inflammatory therapy for treating mild-to-moderate ulcerative colitis and Crohn’s Disease. The drug can be targeted at the gut, is non-systemic, and can be administered via oral tablets or topically. We also see its potential as a treatment for Grade 1 and Grade 2 colitis and diarrhea in oncology patients on immune checkpoint inhibitor (ICI) therapy that enables these patients to remain on ICI therapy due to the non-immunosuppressant nature of niclosamide.

How do you assess the current funding environment for biotechs in the US?

2022 was one of the worst years on record for biotechs, especially for nano and microcap companies, in terms of their ability to raise capital on the public markets and their overall stock performance and market capitalization. We are beginning to see early but positive signs of renewed deal activity in the sector and anticipate that lower interest rates will encourage the return of investors to the sector.

What trends do you see shaping the biotech sector in the months to come?

We continue to see some biotechs reduce staff or even close their doors. And while you never want to see companies and employees suffer, these developments present some good M&A opportunities, especially where a company’s science is strong but the balance sheet is weak. Others, like First Wave BioPharma, are likely to regroup and advance their strongest programs so by the end of the year, we will begin to see the sector reemerge significantly stronger than when it started the year.

How does First Wave BioPharma plan to grow in 2023?

We expect to report topline data from the adrulipase Phase 2 SPAN trial by mid-2023. This would not only be a significant clinical milestone for the company, but it would accelerate our ongoing partnering discussions and advance the asset moving towards a pivotal Phase 3 trial in 2024. More important, however, it’s about bringing us closer to filling the unmet medical needs of CF and CP patients with EPI.