AzurRx BioPharma Shares Surge On Positive Phase 2 MS1819 Data; Primary and Secondary Endpoints Reached Treating EPI In Patients With Cystic Fibrosis (NASDAQ: AZRX)

August 20 07:20 2021

AzurRx BioPharma, Inc. (NASDAQ: AZRX) shares soared by more than 40% on Wednesday after reporting positive topline results from its Phase 2 MS1819 Combination Trial. The study is evaluating MS1819 in combination with the current standard of care, porcine-derived pancreatic enzyme replacement therapy (PERT), to treat severe exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF). The data is excellent.

The study reached both primary and secondary endpoints, showed clinically meaningful improvement in Coefficient of Fat Absorption (CFA) endpoints, and most importantly, indicates that its combination therapy may benefit cystic fibrosis patients with severe EPI. In short, the results are an overwhelming validation of AZRX’s platform. Hence, multiple strategic opportunities to monetize the asset could now be in play.

Interest would be well deserved. And that’s especially true on the potential partnership side where Big Pharma is now far more apt to acquire assets than to develop them. Indeed, the program is strong enough to merit substantial interest. 

Data collected from 20 patients showed that MS1819 in combination with PERT led to clinically meaningful improvements in the primary efficacy endpoint, the Coefficient of Fat Absorption. It was also clinically significant, with patients showing an average gain of more than six percentage points from baseline, compared to the five-point improvement in CFA cited by the clinical literature as clinically significant. Notable, too, the data demonstrated positive improvements in weight gain and other secondary endpoints. And while the results made for an excellent day at AZRX, the same is true for investors following and invested in the story.

AzurRx isn’t shying away from its accomplishment, either. In fact, they are already moving forward, taking its next steps toward marketing approval by finalizing the development of a new enteric-coated microbead formulation they believe can enable more medication to reach the small intestine, thereby enhancing its therapeutic potential. The better news is that the process won’t take long. AzurRx expects that the formulation work will be completed by the end of this year. That puts another potential catalyst in view.

Accelerating MS1819 Program Development

From both the company’s and investor’s perspective, the better news is that its clinically meaningful data does more than validating its treatment thesis. It opens doors of opportunity. And with roughly $13.1M in cash after its July capital raise, they are well-positioned to negotiate from strength. Its cash position, by the way, should be more than enough to fund its next stages of program development. Thus, they don’t need to give assets away on the cheap. Moreover, they are accelerating the pace toward earning final approvals.

AzurRx said it is now developing a new enteric-coated microbead formulation for MS1819 with plans to initiate a bridging study in 2022 evaluating the formulation as a single-agent therapy. And with the goal-posts moved closer, the revenue-generating shots on goal from MS1819 providing a safe and effective means to control EPI has never looked better.

Patients should be paying attention as well, embracing the potential for this therapy to mitigate the debilitating gastrointestinal conditions common to its cystic fibrosis condition. As it stands, roughly 25% to 30% of refractory cystic fibrosis patients with severe EPI cannot achieve adequate nutrition using PERT alone. There are other substantial benefits to patients as well.

Foremost, a safe and effective therapy that allows CF patients to control EPI could significantly diminish the daily pill burden required with PERT-based medications. It also fills the gap where PERT alone is insufficient.

Its MS1819 Phase 2 data suggests that the combination therapy improved fat absorption and other nutritional levels, which are essential for maintaining a healthy weight, better pulmonary function, and prolonged survival in CF patients. Notably important, overall safety was excellent, with no serious adverse events (SAEs) and only a few mild adverse events reported. The better news is that several patients reported feeling considerably better after being on the MS1819-PERT combination for six weeks.

While the news about MS1819 could be transformative to AZRX today, don’t underestimate the rest of its pipeline going forward, either.

Broad Pipeline Of GI Treatment Candidates

In fact, more value from its broad pipeline of targeted, non-systemic large and small molecule therapies to treat gastrointestinal (GI) and infectious diseases may come sooner rather than later. And like its MS1819 program, AZRX designs its other trials to take advantage of lower-risk development pathways.

A potentially transformative in-licensing deal with First Wave Bio could be the next to add to the value proposition. This collaboration could be a value driver in the coming quarters, bringing a new asset -proprietary formulations of micronized niclosamide, a small molecule with anti-viral and anti-inflammatory properties, to its treatment arsenal. It also adds two new therapeutic indications, treatments for COVID-19 GI infections and for immune checkpoint inhibitor-associated colitis (ICI-AC) in advanced cancer patients, to its clinical-stage GI pipeline.

That study is timely. What is significant is that AZRX is one of the few clinical-stage companies focused on treating the long-term effects of the COVID-19 virus, specifically in the GI tract, where data shows it can remain for weeks or months. 

Targeting specific COVID-related conditions, its Phase 2 RESERVOIR trial which launched in April is evaluating FW-1022, an oral micronized niclosamide tablet for COVID-19-related GI infections. If the data shows as intended, the program could lead to marketing one of the most needed drugs in a generation and be a lifesaver to millions of patients worldwide. Even better, it could position them as the first to develop therapeutics to help the world’s population deal with the lasting effects of COVID-19 infections.

Topline data from its Phase 2 RESERVOIR trial is expected during the first quarter of 2022. Thus, despite the jump in share price, more value may be on the way.

MS1819 The Star Of The Day

Undoubtedly, the data from its MS1819 published on Wednesday changes the near-term trajectory at AZRX and gives them the top spot to deliver a best-in-class front-line treatment targeting the debilitating effects of EPI in patients with cystic fibrosis.

Moreover, the news on that program could be the start of several more catalysts to come. And seeing how investors reacted to its EPI in CF treatment candidate, valuations could become cumulative. Of course, that’s a good thing.

Better still, the results from MS1819 demonstrate that they are building a program onto a solid foundation that can deliver multiple shots on revenue-generating goals and target conditions where there are high unmet medical needs. Perhaps best of all, AZRX appears to now have at least one drug on a course toward regulatory approval.

As noted in prior coverage, AZRX is always a single press release away from adding substantial shareholder value. The more than 40% jump on Wednesday proves that point. However, the better news is that AZRX may have more value-creating data to come sooner rather than later. Hence, staying long on this one may be a wise and compelling consideration.

 

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