EP Vantage Interview - Pulmatrix tops up Series B to reach next milestones

Pulmatrix announced a second series B financing round today, securing another $14m from the same syndicate of investors that provided the Massachusetts respiratory company with $30m almost two years ago.

Having successfully hit the three goals set out for the first tranche of money, which included testing lead product PUR118 in man for the first time, the company’s venture capital backers were willing to throw a bit more money in the pot to fund more extensive clinical trials, Robert Connelly, chief executive of Pulmatrix, tells EP Vantage. With five trials in chronic obstructive pulmonary disease (COPD) and cystic fibrosis planned, important data is on the horizon over the next 18 months.

Growing understanding

Pulmatrix was founded almost 10 years ago amid the scramble by the US government to fund biosecurity efforts in the wake of the anthrax mailings – the company’s technology was originally intended as a technique to prevent contaminated individuals spreading whatever nasty contagion they may have contracted.

Over the years however the company’s ambitions have expanded as a growing understanding of the mechanism of action of its technology, called iCalm, and improvements made along the way revealed a broader potential.

PUR118 is the most advanced product to emerge so far and is what Pulmatrix describes as an inhaled cationic airway lining modulator, or iCalm. Comprised of simple cationic salts formulated as a dry powder for inhalation, the company believes the products act through both biophysical and biochemical pathways to improve the symptoms of chronic lung conditions, and possibly infections.

“The last couple of years we have learnt that it not only has anti-infective properties, it is also potently anti-inflammatory and enhances the lungs’ clearance system. So it targets three mechanisms in the lung that bring important efficacies that are not pathogenic or disease specific. Which means it can be applied to a variety of conditions,” Mr Connelly says.

The first indications to be explored are COPD and cystic fibrosis, although the company believes potential also lies in asthma and influenza.

Proof of concept

Work is still very early stage and Pulmatrix has long way to go to establish the product is both safe and effective. However having spent the last couple of years gaining a much deeper understanding of the mechanism of action and developing the technology to re-formulate the product from a liquid to a dry powder – which has resulted in the company’s platform technology iSphere – as well as completing clinical studies in healthy volunteers, it believes now is the time to start more extensive clinical testing.

The five trials will take place over the next 18 months; two phase Ib studies in mild-to-moderate COPD patients have already started. Three further studies of a longer duration, including a cystic fibrosis trial, will start next year.

“Hopefully if all goes well we can move into bigger trials in 2013,” Mr Connelly says.

Considering concerns about the safety of respiratory drugs that have arisen over the last couple of years – seen with attempts to bring inhaled insulin to the market as well as fears about the long-used LABA class of bronchodilators in asthma – Pulmatrix is likely to face a challenging regulatory environment. Still, Mr Connelly believes safety will be iCalm therapies’ key attribute.

“The materials we are using are GRAS – generally recognised as safe - so we’re not breaking any new grounds about new molecules that haven’t been in the body before. The formulation should be very well tolerated and has been so far,” he says.

Locked in

Important data should start to emerge next year, and these first signs of the technology’s safety and efficacy are important milestones. Ultimately a partner will be sought for PUR118, in particular for the large indication of COPD.

“We’re not in any rush but we’d like to get someone in by the end of next year or the beginning of 2013. It will be key to have someone on board before going into phase IIb,” Mr Connelly says.

Also on the cards for next year – thanks to the new funds - is work establishing a stronger patent estate, and hopefully progressing more products generated by the company’s iSphere platform towards the clinic.

Using the dry powder formulation technology that created PUR118, Pulmatrix intends to reformulate other existing agents with iSphere to create new therapeutics, for example inhaled steroids and bronchodilators, as well as antibiotics. Partners will also be sought for this technology, Mr Connelly says.

“We would prefer to strike iSperse deals around specific compounds rather than transfer the technology to someone else. Our core competency is in dry powder formulation.”

With the series B now topped up to $44m, Pulmatrix’s investors have locked themselves in for the next milestones. By the beginning of 2013, they will know whether the top up was worth it.

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