Biophytis SA, a biotechnology company in the clinical development stage listed on Nasdaq CM (BPTS) and Euronext Growth Paris (ALBPS), specializes in the development of therapeutics aimed at slowing the degenerative processes associated with aging and improving functional outcomes for patients with age-related diseases. They have recently announced a partnership with Innovation Solutions Pharma, a company that specializes in supporting clinical development and drug registration operations in South America. The objective of this partnership is to expedite market access for Sarconeos (BIO101) in Brazil.

As part of this collaboration, Innovative Solutions Pharma will serve as a representative for Biophytis in their dealings with the Brazilian agency ANVISA to lift the suspension of the Early Access Program (EAP), which was authorized in early 2022. The EAP is designed to allow up to 80 patients with critical forms of COVID-19 to receive treatment for 28 days while under mechanical ventilation in the intensive care units of Brazilian hospitals. The aim is to provide a therapeutic option to prevent the deaths of these patients.

Given the current surge in the number of COVID-19 patients being hospitalized in Brazil and globally, there is still a lack of treatment options available for severe cases of the disease.

ANVISA's approval of an EAP is primarily based on the following criteria:

1. The product is intended for patients suffering from serious, disabling, and life-threatening diseases.
2. There are no satisfactory therapeutic alternatives among the treatments already registered in Brazil.
3. Authorization to use the product is granted upon request and falls under the responsibility of the prescribing practitioner when it is expected to bring significant benefits to the patient.

Biophytis, has expressed, "Making Sarconeos (BIO101) accessible to Brazilian patients in intensive care due to Covid-19 is a significant step toward bringing our treatment to the market. This program will allow us to treat critical patients and generate crucial new data on the safety and effectiveness of our treatment in real-world conditions. Biophytis plans to initiate this early access program in Brazil in the first quarter of 2024 and intends to further expand this program in France and other countries."

 

Source: biophytis.com

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