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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - LYSADERM (Platelet LYSAte based DERMal formulation for the treatment of skin ulcers)

Teaser

Summary

\"Acute and chronic ulcers of the human skin, mostly represented by diabetic foot ulcers (DFU), pressure ulcers (PU, also termed bed sores), and leg ulcers (LU) cause significantly decreased quality of life in affected patients and high societal cost. Due to the limited efficacy of the currently available preventive and therapeutic procedures, a large proportion of DFU, PU and LU become chronic. Approximately 40% of Diabetic Foot Ulcers are healed within 4 months of treatment
with conventional therapies (advanced medications with engineered bandages, negative pressure, etc.), leaving more than one half of patients without an effective therapeutic option, and with increased risk to require limb amputation, an expensive procedure significantly associated with decreased patientâ€™s survival. Similarly, PUs cannot be completely and timely healed in a large proportion of patients with bed sores treated with standard procedures or with the more expensive advanced medications. Numerous reports from the medical literature show that a gel obtained from the patientâ€™s own platelets (autologous â€˜platelet gelâ€™ or â€˜platelet rich plasmaâ€™, a blood component rich of tissue regenerative factors), when used in combination with procedures of comprehensive wound management, is more effective than conventional treatments alone in promoting faster healing of Diabetic Foot Ulcers, Pressure Ulcers and Leg Ulcers. Platelet rich plasma, commonly referred to as \"\"PRP\"\", is human blood that is spun down and separated producing a concentration of platelets above normal values. Platelets are the clotting cells of our blood, but they also have great potential in enhancing healing of skin, muscles, tendons and ligaments. Studies show that growth factors released by platelets recruit reparative cells, augment tissue repair, and accelerate soft tissue healing. PRP is applied in the form of a gel and can be obtained either from donors blood donations, \"\"allogeneic\"\", or from patient own blood, \"\"autologous\"\". The latter type is increasingly more common because driven by patient\'s need, while the first type is limited by the availability of donations. Episkey\'s mission is to produce exhaustive evidence that cord and adult blood derived medical products are significantly more valuable and therapeutically effective than other products, due to their distinctive biochemical compositions. The company patented a system of medical bags that will be sold to public and private blood banks in order to easily fractionate cord blood donations and make the components usable for further processing.\"

Work performed

This study was dedicated on the technical feasibility and economic profitability of the development of wound cream called LYSADERM.
The Technical Feasibility was focused on: the evaluation of the stability of the platelet lysate (PL) after different times and methods of storage; the evaluation of potential LYSADERM formulations for the preparation of twin-compartment delivery single use packages; and finally the evaluation of potential improvements of the formulation assessed in step ii) to exploit the synergic effect of PL with other wound regeneration components. The results opened the possibility to consider a patent application for the method of preparation, the composition including a platelet lysate and the method of therapeutic administration.
Then we studied the business model, that can follow two paths, one based on Cord Blood and another based on Adult Donor Blood. Both to be viable have been proved to pass through checkpoints, including blood fractionation performed in public and private cord blood banks and in adult donor blood establishments.
Market studies analysed showed that the global stem cell market is expected to reach USD 15.63 billion by 2025, growing at a CAGR of 9.2%. These research projects have opened the possibility of our company to implement several clinical applications of these cells, thereby impacting disease-modifying treatments. Moreover, cellular therapies have been recognized as the next major advancements in transforming healthcare
Then, according to a market Research, we have quantified the global scar treatment market in which our LYSADERM cream will play its role: it was valued $14.9 billion in 2016 and is expected to reach $28.5 billion by 2025. We acknowledged that our LYSADERM will certainly have a fundamental role on the market, thus we have drafted a development plan that will guide us towards the launch on the market in 2023.
In summary, we have identified the revenues stream of the LYSADERM Cream, raising from royalties paid by partner companies producing and commercializing the product, being part of a general strategy of our company comprising all the products portfolio. The envisaged scenarios we have considered embrace a potential for the sale of LYSADERM Cream in the first three years between about 12,000 units (Most Alike Scenario) and 46,000 units (Best Scenario), affecting the total company turnover with a variable percentage between 46% and 54%. After fixing the price of the LYSADERM product set at around 1,000 â‚¬, we have calculated that the total turnover of the Cream in the first 3 years will vary between 12M and 46M â‚¬.

Final results

Based on the results of the present Feasibility Study, we are going to involve a number of entities in various EU countries in order to develop similar models of collaboration between the private industry and the public sector, in the field of cord blood processing and use. In particular, our company Episkey is now working for finding EU partners able to support clinical trials and to increase the scientific knowledge of possible applications of cord blood derivatives.
During the whole 2018, we have promoted a close collaboration with Banc de Sag I Teixitis from Barcelona (Spain) aimed at the implementation of technical procedures and processes to prepare tissue cells culture made of Cord Blood Platelet Lysate and at the design and development of clinical trials with the use of Cord Blood Platelet Gel for the treatment of diabetic ulcers and corneal lesions, as compared to treatments derived from adult platelet gel. In addition, our collaboration has been drafted in order to contribute to the harmonization of the framework of cord blood therapeutic use in EU.
Overall, the timeframe we have fixed for the joint LYSADERM product development embraces the years 2019-2023, comprising: the realization of 3 different phases of R&D in order to characterize the product; regulatory Approval activities; Marketing and Sales actions tat will start from the beginning of 2023.
To conclude, we have confirmed our willingness to pursue the development of our product in collaboration other renowned European organizations, active in the field of blood banking system; we are therefore in further search of European partners to form a consortium able to pursue the development of the idea.