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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 2 - WHILYAS (Wound healing ILYA-style)

Teaser

Summary

ILYA PHARMA is a Swedish, clinical stage, company developing the next-generation biological drugs for treating wounds in skin and mucosa.

The first indication targeted with a large unmet medical need is accelerated healing of large and chronic wounds. Wounds, acute and chronic, entail a huge distress for people and the disrupted barrier is an immediate window for microbes. Small wounds becoming chronic is particularly problematic for people with underlying pathologies that both increase the susceptibility for acquiring wounds as well as reduce healing abilities. Diabetes is one of such pathologies. The occurrence of foot ulcers, or a history thereof, means a 14 years reduction in lifetime expectancy.

In this WHILYAS (Wound Healing Ilya Style) project the objectives are to accelerate development of the drug candidate ILP100 through toxicity testing in large animal models, GMP-manufacturing, a first in human clinical study and outlining a strategic development program forward. The objectives for ILP100 is to heal difficult and chronic wounds in patients with diabetes in a better, faster and more cost-efficient manner than any other drug or medical device available today or in pipeline.

Work performed

The WHILYAS-project is the lead project in Ilya Pharma and when we received the great news of the proposal being granted we first adapted the organization accordingly and put in the right company structures in place to be able to deliver the project in the 18 months as well as to continuously adapt the organization to prepare for future growth and successful drug development. The main technical milestones achieved are that we performed a large animal repeated dose toxicity study with very good safety and efficacy results, scaled the bioprocess and produced a GMP-cell bank and a first GMP-batch and in parallel developing and validating a panel of bioanalyses for the bioprocess, cell banks, drug product as well as for non-clinical and clinical samples. The development plan have also been verified by regulatory bodies. Further the project has been presented at numerous conferences and events and we have gotten a good spread in different media.

Final results

Drug development has long lead times and if successful engage global multidisciplinary team and serves multiple markets. During this period the growth of Ilya Pharma and the subsequent growth of other companies have been interesting to follow as well as how we have built a strong and integrated team of senior experts, researchers, industrial expertise and external parties. This structure has accelerated the development of ILP100 and is a great resource for the future clinical trials and commercial development. An international expert cluster have been formed around the development of the drug candidate and technology platform.

Due to the long lead times in drug development the impact has not yet reached the patients. Though the currently available devices have been mapped in the different market and care segments as well as the current global pipeline of medical products in clinical trials. With this information and the non-clinical data available cases of health economics and reimbursement models have been initiated to understand the full societal impact of the product, once approved and used.

Ilya Pharma is now in a Series A/mid-financing investment round to finance two phase II clinical trials in different wound indications as well as consequent regulatory and commercial activities. The activities in the WHILYAS project are key to the future execution plan and ability to secure financing.