Promore Pharma and Cellastra Inc. announce Phase III clinical collaboration to develop therapeutic peptide PXL01 for the US market

PXL01 first indication targets major unmet need for prevention of post-surgical adhesions after tendon- and nerve-repair procedures.

STOCKHOLM, SWEDEN and SAN FRANCISCO, CA, December 21, 2016– Promore Pharma, a specialist biopharmaceutical developer of therapeutic peptides, and Cellastra Inc., a clinical stage developer of pharmaceutical assets, today announced the signing of a term sheet, towards a strategic collaboration for the Phase III clinical development of PXL01 and subsequent registration and marketing in the US and Canada.

"This co-development initiative for PXL01 in the US market is pivotal to our strategic approach and Cellastra is an ideal partner for us,” said Jonas Ekblom, President of Promore Pharma, “Together we will deploy our combined development capabilities and networks to expedite the development of this first-in-class pharmaceutical product for the North American market.”

The collaboration will target a first indication of prevention of post-surgical adhesions after tendon- and nerve-repair procedures in the hand, arm and foot.Adhesions frequently occur during the healing process, when scar tissue forms and connects tendons to the surrounding tendon sheath, thereby impeding normal tendon function.

Adhesions are common to all invasive surgical procedures, in particular after tendon injuries in the hand. Hand injuries usually affect young, active and otherwise healthy people and are often caused by sports or recreational injuries or work-related accidents. These adhesions tend to cause reduced mobility and difficulties performing everyday work task and recreational activities that involve fine motor skills such as the use of machinery, computers, playing instruments and sports. The result may be a substantial and permanent impairment of quality of life. An estimated target market of more than 350,000 tendon and nerve repair procedures with a high risk of incapacitating post-surgical adhesions/scars are conducted annually in North America. There are no pharmaceutical products available on the market to prevent adhesions and scars.

“PXL01 is an advanced clinical-stage asset with a perfect fit for Cellastra’s strategy around first- and best-in class products for tissue repair and wound healing – the treatment focus-area where our US development expertise can be leveraged optimally,” commented Karl Mettinger, co-founder, President and CEO, Cellastra Inc.

“PXL01 addresses the large unmet medical need that exists because 30-50 percent of sports and many work and home activity injuries involve tendons, all with substantial quality of life consequences and substantial cost of health care,” said Professor Christopher H. Evans, Rochester, Maurice Müller Professor of Orthopaedic Surgery Emeritus, Harvard Medical School. He is a new member of the Cellastra Scientific Advisory Board and senior author of a recent review publication of new treatment modalities for tendon repair².

Promore Pharma, which discovered and developed PXL01, has reported promising safety and efficacy results in a peer-reviewed publication of a Phase IIb prospective, randomized, placebo controlled, double-blind clinical trial involving 138 patients undergoing flexor tendon repair surgery[1]. This proprietary product candidate is based on a human peptide sequence that is part of the innate immune system and found to have potent anti-infective, anti-inflammatory, and immunomodulatory effects. PXL01 has been shown to limit the production of inflammatory markers and to down-regulate secretion of Plasminogen Activator Inhibitor 1 (PAI-1), considered to reflect important mechanisms in the cause of scarring and adhesions.

Deal terms of the collaboration have not been disclosed.

[1](Wiig et al, PLOS One, 2014, 9, 10 e110735), ² Docheva et al, Adv Drug Deliv Rev. 2015, 84:222

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About Promore Pharma (www.promorepharma.com)
Promore Pharma, is a biopharmaceutical company specialized in the development of therapeutic peptides for local application in advanced wound care. The company’s vision is to develop a portfolio of unique development programs representing high medical value in advanced wound- and skin care that ultimately, through global partnerships, will result in first-in-class products. The current development pipeline includes several therapeutic peptides of which two programs are in clinical development, with potential for use in several medical applications. Rosetta Capital, Midroc New Technology and PharmaResearch Products Ltd are the main investors in Promore Pharma, which is affiliated with Lipopeptide AB.

About Cellastra Inc. (www.cellastra.com)
Cellastra Inc. is a private biotech firm in San Francisco, founded and managed by proven industry executives with a mission to develop first-in-class therapeutics and disruptive technologies that address serious unmet medical needs through partnerships designed to reduce risk and accelerate product development. Cellastra identifies and in-licenses assets, multiplying value by completing preclinical/clinical development via partnerships with world class institutions, then monetizes programs through partnering with pharmaceutical companies at relevant milestones.The initial portfolio focuses on tissue and tendon repair and a platform of collagen mimetic peptides for wound healing using proprietary stem cell, exosome and biomatrix combinations.

Contact
Jonas Ekblom

President, Promore Pharma

Tel: [+1] 714 369 0478

E-mail: jonas.ekblom@promorepharma.com

Karl L. Mettinger

President and CEO, Cellastra Inc

Tel: [+1] 877 650 3417

E-mail: karl.mettinger@cellastra.com