Non-healing wounds are a sizable burden for the individual patient and for the health care system.
Today, there are more than 15 million patients globally, and virtually no medical progress has been
made over the last few decades in regard to pharmacological treatments.

“LL-37 is a therapeutic peptide which contributes to enhanced healing of chronic wounds through its biological role in the human host defense system”, said Jonas Ekblom, CEO of Pergamum AB. “This clinical trial will allow us to evaluate a promising new treatment aimed for the segment of advanced wound care products.”

In this double blind multicenter study, 34 patients with venous leg ulcers have been randomized to
receive either placebo or one of three different doses of LL-37. The primary objective of the trial is to assess the safety and tolerability of Pergamum’s proprietary formulation of the therapeutic peptide LL-37. The trial will be concluded in 2013. The principal investigator is Dr. Ola Rollman, associate professor at the Department of Medicine at Uppsala University, Sweden.

“We look forward to evaluate the top line-data from the study, which we anticipate will be presented
in the third quarter”, said Torbjörn Bjerke, CEO of Karolinska Development AB and Chairman of the
Board of Pergamum.

For further information, please contact:

Jonas Ekblom, President and CEO, Pergamum AB
Phone: +46 (0)70 551 6660, e-mail: jonas.ekblom@pergamum.com

Torbjörn Bjerke, CEO, Karolinska Development AB
Phone: +46 (0)72 744 41 23, e-mail: torbjorn.bjerke@karolinskadevelopment.com

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Pergamum’s strategy is to develop state of the art therapeutic peptides for the treatment of infections and wounds. As the company is reaching proof-of-concept in patients with three of its programs, it has now started the search to find partners for the programs or an acquirer of the company. As part of this active search, Pergamum has appointed Ernst & Young as a strategic advisor.

“Ernst & Young has a formidable international network,” said Jonas Ekblom, CEO of Pergamum AB. “Together with their team, we are now commencing the preparatory steps for a sale or a significant strategic alliance, as we await the final data from our remaining clinical trials.”
Pergamum has developed three clinical stage peptides – LL-37, PXL-01 and DPK-060 – for topical administration for (i) treatment of chronic wounds, (ii) prevention of scars and adhesions and (iii) anti-infective treatment. The peptides in development are structurally derived from human molecules and optimized in terms of their biopharmaceutical.

“The company has now completed the patient enrolment for three clinical trials that are expected to generate final clinical study reports in 2013. This is a logical time point to start searching for acquirers or strategic partners that can continue the development of these exciting programs towards the market”, said Staffan Folin, Partner, Ernst & Young. “It is a pleasure for us to work together with Pergamum to find a commercial partnership for their promising new treatments aimed for the segment of advanced wound care products.”

For further information, please contact:

Jonas Ekblom, President and CEO, Pergamum AB
Phone: +46 (0)70 551 6660, e-mail: jonas.ekblom@pergamum.com

The two companies will collaborate on the preclinical and clinical development of a novel therapeutic peptide that has been developed by Pergamum AB. The development will be conducted at the facilities of Cadila Pharmaceuticals Ltd in Ahmedabad, India. Cadila will be responsible for all costs related to the development of the product up to Phase II and global rights will be shared between the companies.

Infections caused by resistant microorganisms often fail to respond to conventional treatment, resulting in prolonged illness and greater risk of death. There is a significant need for safe and effective new products to avoid infections.

“Pergamum has developed a new class of short synthetic peptides with both anti-infective and anti-inflammatory properties derived from the body’s own defense system. There is a rapidly increasing global prevalence of antibiotics resistance that limits the therapeutic value of conventional products, and we think that we can meet this need with this novel therapeutic peptide”, says Jonas Ekblom, CEO of Pergamum.

“This partnership combines Cadila’s advanced product development capabilities with the innovative capacity of Pergamum. Cadila Pharmaceuticals bring their expertise in drug development and demonstrates that commitment towards developing affordable innovative compounds to the market in this collaboration”, says Rajiv Modi, Chairman and Managing Director of Cadila Pharmaceuticals Ltd.

For further information, please contact:

Jonas Ekblom, President and CEO, Pergamum AB
Phone: +46 (0)8 470 37 40, e-mail: jonas.ekblom@pergamum.com

Download press release: Press release in English

“The study results announced today, clearly shows the potential for DPK-060 to play a significant role in the future treatment of outer ear infections. We estimate that more than 10 million people in the US, EU and Japan seek medical care for this disease, causing a considerable workload at otolaryngology departments”, said Jonas Ekblom, CEO of Pergamum AB.”There is a clear medical need to avoid rapidly increasing global prevalence of antibiotics resistance that limits the therapeutic value of conventional products.”

The completed study is a Phase II double-blind, randomized, placebo-controlled, multi-center trial in patients with acute external otitis. The primary objective of the trial was to assess local tolerability and safety of 2% DPK-060 ear drops in infections caused by bacterial or fungal pathogens. The trial enrolled 69 patients. After top-line analysis of the study data, it was concluded that DPK-060 is safe and tolerable for topical treatment in the outer auditory channel. In addition, secondary endpoints showed a complete cure in 85% – 94% (depending on which rating scale is utilized) of the patients after 10 days of treatment with DPK-060, and the difference compared to placebo was statistically significant.

External otitis, also frequently called swimmer’s ear is one of the most common ear, nose and throat infections treated in out-patient settings. The clinical signs of the condition can range from mild inflammation and discomfort to life-threatening symptoms. DPK-060 is a novel anti-microbial peptide, which is unlikely to evoke antibiotic resistance.

“The data from this randomized study demonstrate that topical treatment with DPK-060 is safe and well tolerated. Furthermore, a sizable fraction of the patients that received DPK-060, demonstrated complete clinical cure after 10 days of treatment. As a consequence, we will start searching for a corporate partner for this program in 2013”, said Torbjörn Bjerke, CEO of Karolinska Development AB and Chairman of Pergamum AB.

For further information, please contact:

Jonas Ekblom, President and CEO, Pergamum AB Phone: +46 (0)8 470 37 40, e-mail: jonas.ekblom@pergamum.com

Torbjörn Bjerke, CEO, Karolinska Development AB Phone: +46 (0)72 744 41 23, e-mail: torbjorn.bjerke@karolinskadevelopment.com

Download press release:

Press release in English

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“Non-healing wounds are a huge burden for the individual patient and for the health care system. Today, there are an estimated 15 million patients with chronic wounds globally, and virtually no medical progress has been made in this area over the last few decades”, said Jonas Ekblom, CEO of Pergamum AB. “This clinical trial will allow us to evaluate a promising new treatment, based on the body’s own immune defense, for patients with venous leg ulcers. The ultimate goal is to accomplish faster healing and improved quality of life for patients who typically have a poor prognosis.”

In this double blind multicenter study, patients with chronic leg ulcers will be randomized to receive either placebo treatment or one of three different doses of LL-37. The primary objective of the trial is to assess the safety and tolerability of Pergamum’s proprietary formulation of the therapeutic peptide LL-37. The Phase I/II study is expected to enroll 32 patients. The principal investigator is Dr. Ola Rollman, associate professor at the Department of Medicine at Uppsala University, Sweden.

“This is the third drug candidate developed by Pergamum to enter clinical development. It is primarily a safety study but we will also be able to see early signs of potential efficacy”, said Torbjörn Bjerke, CEO of Karolinska Development AB and Chairman of the Board of Pergamum.” The progress of LL-37 into human trials is yet another sign of our ability to bring our project portfolio to maturity.”

For further information, please contact:

Jonas Ekblom, President and CEO, Pergamum AB Phone: +46 (0)8 470 37 40,e-mail: jonas.ekblom@pergamum.com

Torbjörn Bjerke, CEO, Karolinska Development AB Phone: +46 (0)72 744 41 23, e-mail: torbjorn.bjerke@karolinskadevelopment.com

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Press release in English

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Top-line results from the Phase II trial on subjects that have undergone tendon repair surgery in the hand have now been analyzed. Treatment with PXL-01 was well tolerated, and did not adversely affect tendon or wound healing. The study did not show any statistically significant difference between the group that were treated with PXL-01 and the placebo group measured as TAM2 (Total Active Motion, sum of two finger joints), which was the primary end point. However, there is a clear trend that treatment with PXL-01 may improve the postoperative outcome as the number of patients categorized as having good or excellent mobility of the injured finger 12 weeks after the surgery, was higher compared to treatment with placebo. In the group treated with PXL-01, 67 percent of the subjects demonstrated excellent or good range of motion according to Strickland’s classification scale, compared to 48 percent of the subjects in the group treated with placebo. This endpoint is an important indicator of deficit in hand function after the surgical procedure.

In total, 138 patients undergoing hand surgery was treated in this prospective, double-blind, randomized placebo controlled clinical trial conducted in Sweden, Denmark and Germany. The final Phase II report is expected to be published in the third quarter 2012 while the trial continues to include 6 and 12 months follow up.

Jonas Ekblom, CEO of Pergamum:
“Adhesion formation after surgery is a considerable debilitating adverse effect and there are currently no pharmacological products for treatment of these complications. We are now analyzing this complex data set to decide on the next step in the PXL-01 clinical program. We are looking forward to concluding the study in February 2013 including follow up data and are hopeful that the positive trends observed will continue.”

According to a recent article published in The Lancet, there are more than 230 million surgical procedures performed in the world annually and in many of these cases the patients are at risk for the formation of surgical adhesions.

Torbjörn Bjerke, CEO of Karolinska Development AB and Chairman of Pergamum AB:
“This is a study on patients after hand surgery, but there are several types of surgery where patients frequently experience complications with adhesions. These undesirable adverse effects are both painful for patients and costly for society, why an effective pharmaceutical product targeting postsurgical adhesions would have great medical and commercial potential. We will await the full analysis of this data before we make any further conclusions.”

For further information, please contact:

Jonas Ekblom, President and CEO, Pergamum AB
Phone: +46 (0)8 4703740, e‐mail: jonas.ekblom@pergamum.com

Torbjörn Bjerke, CEO, Karolinska Development AB
Phone: +46 (0)72 744 41 23, e‐mail: torbjorn.bjerke@karolinskadevelopment.com

Download press release:
Press release in English
Press release in Swedish

Pergamum AB was formed in 2009 with the objective of synergetically aggregating a number of programs in the field of locally delivered biopharmaceuticals. The company has operations in several locations in Sweden. The company announced today that Dr. Margit Mahlapuu will take on the role as Chief Scientific Officer in Pergamum.

”I would like to congratulate and welcome Dr. Margit Mahlapuu in her new role as Chief Scientific Officer. She provides the strength and continuity that we need in the development organization of our company.” said Jonas Ekblom, CEO of Pergamum. “This is part of an ongoing consolidation process. Coordinating our company’s efforts in the most important development programs, while streamlining our operations, will reduce ongoing operating expenses and increase quality.”

The company continues clinical development of the core programs: PXL-01, DPK-060 and LL-37 for the treatment of wounds and skin infections. Moreover, Pergamum will seek to co-develop some of its initiatives in strategic partnerships with other companies. Dr. Margit Mahlapuu, who also holds a position as Associate Professor in Medicine at the University of Gothenburg, has more than 15 years of life science experience and has held several senior positions in small and large pharmaceutical companies. Most recently, Dr. Mahlapuu has served in the role as Executive Director for the PXL-01 technology platform.

For further information, please contact:
Jonas Ekblom, CEO,Pergamum AB
Phone: +46 (0)70 551 66 60, e-mail: jonas.ekblom@pergamum.com

About Pergamum AB
Pergamum is a biopharmaceutical company specialized in the development of therapeutic peptides for local application in infections and wounds. Within Pergamum, companies and projects are managed as fully integrated operating units. The company’s vision is to develop a portfolio of unique development programs representing high medical value that ultimately, through global partnerships, will result in first-in-class and first-in-category products. The current development pipeline includes three therapeutic peptides that have reached clinical stage, with potential for use in several medical applications.

In total, 138 patients undergoing hand surgery have been included in Pergamum’s placebo controlled, multi-center trial that has been conducted in Sweden, Denmark and Germany. The trial evaluates the safety and effectiveness of the novel therapeutic peptide PXL01 to improve mobility and function of the hand after surgery. Many patients undergoing hand surgery today suffer from debilitating scar formation which reduces the range of motion and complicates daily activities. PXL01 is a product under development with the purpose to reduce the formation of obstructing scars and restore mobility and function back to the patient’s normal level. The final patient will be followed-up for a period of 12 weeks and results from the study are expected to be presented later this year.

“It is an important milestone to be able to finalize the recruitment to this exciting study. PXL01 has the potential of becoming, the first pharmaceutical product registered to target post-surgical adhesions. We believe that this new treatment concept can have a great impact on the surgical outcome, not only for hand surgery patients but also for patients undergoing knee and shoulder surgery, after which adhesion formation is a considerable debilitating sideeffect”, said Jonas Ekblom, CEO of Pergamum.

According to a Lancet article, there are more than 230 million surgical procedures performed in the world annually and in many of these cases the patients are at risk for the formation of surgical adhesions. Pergamum estimates that the global market for surgical sealants, wound closure and anti-adhesion was in excess of USD 9bn in 2011. Currently there are no pharmaceutical products available for prevention of adhesion. A successful Phase II trial would open up the possibility for the development of similar treatments for a variety of surgical procedures.

“The dermatology and wound care field represents a huge market opportunity, with over USD 13bn in global annual sales in wound care alone, according to Espicom. Many products on the market are old and innovation in the field has been scarce. PXL01 is one of several innovative projects in Pergamum’s pipeline aiming at creating unique specialty care products in this area”, said Torbjörn Bjerke, CEO of Karolinska Development AB and Chairman of Pergamum AB.

For further information, please contact:

Jonas Ekblom, CEO, Pergamum AB
Phone: +46 (0)70 551 66 60, e-mail: jonas.ekblom@pergamum.com

Torbjörn Bjerke, CEO, Karolinska Development AB
Phone: +46 (0)72 744 41 23, e-mail: torbjorn.bjerke@karolinskadevelopment.com

Download press release:
Press release in English
Press release in Swedish

“Every year more than 10 million people world‐wide seek medical care for treatment of infections in the outer ear. There is a significant medical need to avoid rapidly increasing global prevalence of antibiotics resistance that limits the therapeutic value of conventional products, and we think that we can meet this need with DPK‐060″, says Jonas Ekblom, CEO of Pergamum

Pergamum’s Phase II‐study is a double‐blind, randomized, placebo‐controlled, multi‐center trial in patients with acute external otitis. The objectives of the trial are to assess the efficacy, local tolerability and safety of DPK‐060 ear drops in infections caused by bacterial or fungal pathogens. The trial is expected to enroll approximately 70 patients. The principal investigator for this trial is Dr. Pekka Koskinen, who is Managing Director at the Center för Läkemedelsstudier, Malmö, Sweden.

DPK‐060 is a novel anti‐microbial peptide which is structurally derived from the endogenous human protein kininogen. It has a broad‐spectrum action on bacteria such as Staphylococcus aureus, including multidrug‐resistant strains, as well as fungi such as Candida and Malassezia. DPK‐060 has shown positive data in a clinical Phase II study in atopic dermatitis and has the potential to treat many other dermatological conditions where these microorganisms are a major problem.

“Pergamum has developed a new class of broad‐spectrum‐acting antimicrobial agents based on a peptide from the body’s own defence system”, says Torbjörn Bjerke, Chairman of the board in Pergamum and CEO of Karolinska Development AB. “The results of this clinical study is an important step towards a potential new prescription product for topical application that could change the treatment of skin infections, not only in the field of external otitis, but also in several other infections under investigation by Pergamum.”

For further information, please contact:

Jonas Ekblom, President and CEO, Pergamum AB
Phone: +46 (0)70 551 66 60, e‐mail: jonas.ekblom@pergamum.com

Torbjörn Bjerke, CEO, Karolinska Development AB
Phone: +46 (0)72 744 41 23, e‐mail: torbjorn.bjerke@karolinskadevelopment.com

Download press release:
Press release in English
Press release in Swedish

Eftersom bakterier är negativt laddade och peptiderna har positiv laddning dras de till varandra. Peptiderna löser upp cellmembranet och bakterien dör. Det hela är över på någon minut. Vanlig antibiotika verkar inom några timmar eller dygn. Den tiden kan räcka för att resistens ska uppstå.

Samtliga tre peptider är kroppsegna ämnen som ingår i immunförsvaret. De utvärderas just nu i kliniska försök. Först ut på marknaden blir troligtvis ett läkemedel som ska förhindra ärrbildning och infektioner i kirurgiska sår.

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