LONDON (ShareCast) - (ShareCast News) - Clinical stage biopharmaceutical company Faron Pharmaceuticals updated the market on Thursday, ahead of its full year 2016 audited financial results which its board said will be announced on 29 March.
The AIM-traded firm said for its Traumakine project, it expects to obtain the read-out for the pan-European phase III trial results during H2 2017.

It had recently recently received the third recommendation from the trial's Independent Data Monitoring Committee to continue the study without any modifications, and it had established a manufacturing plan to build its stocks of Traumakine.

Subject to a positive outcome of the INTEREST study, having manufacturing in place should facilitate the application process for market approval of Traumakine, the board said.

It also planned to commence a Phase II US safety study with Traumakine in H2 2017, and expected that the full study will take 12 months to complete.

Faron also currently expected the Japanese Phase III pivotal study recruitment for the treatment of ARDS with Traumakine, run by its Japanese licensing partner Maruishi Pharmaceutical, to progress towards completion during 2017.

The first recruited patient for its Traumakine clinical study for the treatment of patients with rupture of acute abdominal aorta is expected in Q1 2017.

It expected to get interim results from the 160-patient trial in 12 to 18 months, with the aim of the trial is to reduce mortality in operated RAAA patients, which normally varies from 30 to 50% of all patients surgically operated on.

The study will also assist in the design of Traumakine trials for single organ failures.

At Faron's Clevegen development project, the company said it expects to file the first clinical trial application with the UK regulatory authorities in late 2017 or early 2018.

The first, and primarily safety focused, trial is to be conducted with liver cancer patients at the Birmingham University Liver Cancer Centre, the board confirmed, and is expected to continue into a Phase II study via an adapted trial design for hepatocellular carcinomas patients to recognise early efficacy signals.

Faron said the high yield Clevegen production clones prepared by Selexis for Faron demonstrated 5+ g/l production levels without optimisation of the bioreactor conditions.

The company said it expects that its manufacturing partner Abzena will provide purified drug substance for the Clevegen pre- and clinical studies during Q2 2017.

At the end of 2016, Faron confirmed it had approximately €11.5m in cash.

"We are very excited about Faron's prospects for 2017 and beyond," said CEO Markku Jalkanen.

"We are getting close to read-out of the INTEREST trial, which we believe could revolutionise intensive care practices for ARDS patients.

"We are therefore continuing to prepare the business in anticipation of commercial launch soon after the trial results are received."

In addition, Dr Jalkanen said the company was continuing to progress and expand its clinical development programme in order to increase indications targeted and maximise shareholder value.

"The company has made new hires and I would also like to take the opportunity to thank Dr Ilse Piippo for working with us since 2007 and building the current regulatory pathway for Traumakine.

"The skills and commitment she has shown over the years are still evident as she builds the road for treatment with Traumakine in paediatric applications.

"As a replacement, Dr Matti Karvonen has already demonstrated his strengths in the past eight months and I am confident that the Faron pipeline will progress well under his supervision."

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