Bright Prospects for Pulmatrix in 2017 and Beyond

With its Drug Development Programs on Track, Pulmatrix is Meeting all its Targets – and is Delivering on the Huge Promise of its Innovative Inhaled Drug Delivery Technology, According to CEOCFO

LEXINGTON, MA / ACCESSWIRE / November 1, 2016 / CEOCFO Magazine, an independent investment publication that highlights important technologies and companies, today announced that Pulmatrix, Inc. (NASDAQ: PULM) is successfully meeting its drug development targets and is delivering on the huge promise of its innovative inhaled drug delivery technology. CEOCFO concludes that Pulmatrix is on track to achieving its goal of becoming a major pharmaceutical company.

In an interview with CEOCFO, Pulmatrix Chief Executive Officer Robert W.
Clarke, Ph.D., described the company’s accomplishments in 2016, and its plans for 2017 and beyond. “It’s been a great year for us,” Clarke said. “We’ve done everything we said we would do and plan to move our lead programs forward quickly in the next few years.”

Pulmatrix’s original innovation was creating a better technology for inhaling drugs into the lungs. The company engineered dry powders that ‘fly’ much more easily into patients’ airways than the current technology, while delivering virtually any type of drug. The Pulmatrix iSPERSETM platform thus can treat lung diseases more effectively than can current inhaled drugs. It also has great potential for many other diseases, including cancer, because the lungs offer a very efficient portal for delivering drugs locally to targets within the airway or systemically into the bloodstream.

Clarke carefully selected Pulmatrix’s first two drug candidates using two criteria: bringing important medical benefits to patients and offering quick paths to market. “We decided to focus on high value products for both patients and our business,” Clarke explained.

The first, PUR00200, is an inhaled drug for COPD that is being developed in collaboration with pharmaceutical giant Mylan. Under a special regulatory path in Europe, Pulmatrix can get rapid approval by simply showing that PUR0200 is “bioequivalent” to an existing blockbuster product, meaning that it can deliver the same amounts of drug to the lungs resulting in similar patient exposure.

“That program is right on target,” said Clarke. “As we promised, we successfully completed a clinical trial in July showing a clear path to bioequivalence.” The data showed that several formulations of PUR0200 not only work as planned, they also achieve the required levels of the drug in the lung with an 80% lower dose, because the delivery technology is so efficient. “That’s a major advantage,” said Clarke.

The next step is a larger trial that Pulmatrix will begin in the second quarter of 2017,
using the best formulation from the first trial. The data, expected in Q4, will then enable Pulmatrix to conduct a pivotal, final trial in 2018. “We are making sure that, when we get to the pivotal trial, we’ve maximized the potential for a successful outcome,” said Clarke. In parallel, the company is also working with its contract research organization to scale up production for the expected launch of the product.

Pulmatrix’s second drug candidate is an inhaled antifungal drug, PUR1900, which also offers major medical benefits. Many cystic fibrosis patients suffer from a condition called allergic bronchopulmonary aspergillosis (ABPA) caused by fungal infections. Studies show that an oral drug can help, but at the cost of severe side effects. That’s because high levels of drug in the bloodstream are needed to get enough drug to the lungs. By delivering the same drug directly to the lungs, PUR1900 can avoid those side effects.

As it promised, Pulmatrix was awarded ‘orphan
drug’ designation from the FDA for PUR1900 in 2016, putting the drug on a quick regulatory path to approval. It also successfully completed a
clinical trial confirming the huge advantages of delivering the drug to the lungs compared to an oral pill. The trial also showed that the drug has potential for treating fungal infections in the lungs of severe asthmatics. “Our commercial assessment shows a viable opportunity for CF, but a much greater opportunity for severe asthma,” said Clarke.

In the second quarter of 2017, Pulmatrix will move ahead with a larger trial and is then targeting a key proof of concept trial with CF patients in 2018. At the same time, it is developing a second inhaled antifungal drug formulation in parallel that could fight a wider range of fungal infections allowing the company to consider differentiated products for multiple indications.

CEOCFO’s analysis suggests that smart investors have a chance to get ahead of the pack, since Pulmatrix’s potential – and its continued success at meeting every goal and target – remains largely under the radar. As Clarke said: “I don’t think much of the investment community has gleaned the size of the opportunities we have.”

Those opportunities will continue to grow once Pulmatrix has products on the market and the resources to pursue breakthrough inhaled drugs for everything from pneumonia to cancer.

Contact:

Bud Wayne, Editorial Executive
CEOCFO Magazine
budwayne@ceocfomagazine.com

SOURCE: CEOCFO Magazine

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