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Details:
Under the partnership, Skyepharma will develop finished product batches meeting the GMP standards of Sarconeos (20-hydroxyecdysone), an orally administered small molecule, for severe forms of Covid-19.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Infections and Infectious Diseases Product Name: Sarconeos
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biophytis
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership September 25, 2023
Details:
The agreement aims for the production of the active compound in Sarconeos (20-hydroxyecdysone), Biophytis' main drug candidate developed for three indications, severe forms of Covid-19, sarcopenia and Duchenne muscular dystrophy.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Infections and Infectious Diseases Product Name: Sarconeos
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biophytis
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 18, 2023
Details:
BIO101 (20-hydroxyecdysone) is the first oral daily MAS receptor activator and has demonstrated metabolic effects on muscle and fat tissues. It is being evaluated for the treatment of obesity.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Nutrition and Weight Loss Product Name: BIO101
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2024
Details:
Sarconeos (BIO101) activates the MAS receptor, a key component of the protective arm of the RAS, and has been shown to significantly improve respiratory function in several preclinical models. It is being developed for treating severe forms of COVID-19.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Infections and Infectious Diseases Product Name: Sarconeos
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2023
Details:
Sarconeos (BIO101) activates the MAS receptor, a key component of the protective arm of the RAS, and has been shown to significantly improve respiratory function in several preclinical models. It is being developed for treating sarcopenia.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Musculoskeletal Product Name: Sarconeos
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 11, 2023
Details:
Sarconeos (20-hydroxyecdysone) activates the MAS receptor, a key component of the protective arm of the RAS, and has been shown to significantly improve respiratory function in several preclinical models. It is being developed for treating COVID-19.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Infections and Infectious Diseases Product Name: Sarconeos
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 20, 2023
Details:
The proceeds will fund research and development and clinical trials of its product canditates including, Sarconeos (BIO101), a small molecule in development for age-related neuromuscular (sarcopenia and Duchenne muscular dystrophy) and cardiorespiratory (Covid-19) diseases.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Infections and Infectious Diseases Product Name: Sarconeos
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $3.8 million Upfront Cash: Undisclosed
Deal Type: Public Offering July 19, 2023
Details:
Sarconeos (20-hydroxyecdysone) activates the MAS receptor, a key component of the protective arm of the RAS, and has been shown to significantly improve respiratory function in several preclinical models. It is being developed for treating sarcopenia.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Musculoskeletal Product Name: Sarconeos
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 10, 2023
Details:
Sarconeos (BIO101, 20-hydroxyecdysone), is a small molecule, administered orally, a key component of the protective arm of the RAS, has shown positive results in the treatment of adult patients with a severe form of COVID-19.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Infections and Infectious Diseases Product Name: Sarconeos
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Intsel Chimos
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2023
Details:
Sarconeos (BIO101) activates the MAS receptor, a key component of the protective arm of the RAS, involved in the regulation of smooth, cardiac and skeletal muscle metabolism and plays a key role in muscle function and mobility. It is being developed for sarcopenia.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Musculoskeletal Product Name: BIO101
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 15, 2023
Details:
The funding will be used to finance the Marketing Authorisation Applications of BIO101 (sarconeos), an orally administered small molecule, for the treatment of severe forms of COVID-19.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Infections and Infectious Diseases Product Name: BIO101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $2.5 million Upfront Cash: Undisclosed
Deal Type: Financing May 11, 2023
Details:
Sarconeos (BIO101) activates the MAS receptor, a key component of the protective arm of the RAS, and has been shown to significantly improve respiratory function in several preclinical models. It is being developed for treating severe forms of COVID-19.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Infections and Infectious Diseases Product Name: BIO101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 09, 2023
Details:
Under the terms of the agreement, Intsel Chimos will be the operating pharmaceutical company/exploitant, partner and distributor in France for the drug BIO101 (sarconeos) developed by Biophytis, requested for the treatment of severe forms of COVID-19, if approved.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Infections and Infectious Diseases Product Name: BIO101
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biophytis
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 02, 2023
Details:
Sarconeos (BIO101) activates the MAS receptor, a key component of the protective arm of the RAS, and has been shown to significantly improve respiratory function in several preclinical models. It is being developed for treating severe forms of COVID-19.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Infections and Infectious Diseases Product Name: BIO101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 27, 2023
Details:
BIO101 activates the MAS receptor, a key component of the protective arm of the RAS, and has been shown to significantly improve respiratory function in several preclinical models.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Infections and Infectious Diseases Product Name: BIO101
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 02, 2023
Details:
BIO101 (sarconeos), an orally administered small molecule, stimulates biological resilience through activation of the MAS receptor, a key component of the RAS. The RAS is a fundamental endocrine system that control fluid balance, blood pressure and cardio-vascular function.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: BIO101
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 01, 2022
Details:
In the primary analysis, Sarconeos (BIO101) reduced by 39% the risk of respiratory failure or early death at 28 days (primary endpoint) compared to placebo (15.8% vs 26.0%, adjusted difference 11.8% in favor of treatment, p=0.07).
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Infections and Infectious Diseases Product Name: BIO101
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 06, 2022
Details:
In parallel, Sarconeos (BIO101) is being evaluated in a Phase 2-3 study (COVA), in Europe, Latin America, and the US, for the treatment of non-intubated hospitalized patients with severe respiratory manifestations of COVID-19.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Infections and Infectious Diseases Product Name: BIO101
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 03, 2022
Details:
Sarconeos (BIO101) showed a very good safety profile at the doses of 175 mg bid and of 350 mg bid. Based on the SARA-INT results, Biophytis is now preparing the phase 3 program and associated regulatory agency interactions.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Musculoskeletal Product Name: BIO101
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 29, 2021
Details:
The second Interim Analysis (“IA2”) based on 155 hospitalized patients shows no futility, with efficacy results in the promising zone, indicating that BIO101 remains a candidate treatment for acute respiratory failure associated with COVID-19.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Infections and Infectious Diseases Product Name: BIO101
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2021
Details:
The COVA clinical program is a global, multicentric, double-blind, placebo-controlled, group-sequential, and adaptive design two-part Phase 2-3 study assessing Sarconeos (BIO101) in patients aged 45 and older, hospitalized with severe respiratory manifestations of COVID-19.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Infections and Infectious Diseases Product Name: BIO101
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 16, 2021
Details:
The objective of the SARA-INT Phase 2 study is to evaluate the efficacy and safety of Sarconeos (BIO101) in a randomized placebo-controlled study in patients over 65 years suffering from sarcopenia and considered at high risk of mobility disability.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Musculoskeletal Product Name: BIO101
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2021
Details:
The Company receives a favorable opinion from the DMC on the safety of Sarconeos (BIO101) in the COVA study following first interim analysis. Patient enrollment has now reached 97 of the 155 planned for the second interim analysis.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Infections and Infectious Diseases Product Name: BIO101
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2021
Details:
The global, multi-centre, double-blind, placebo-controlled, group-sequential and adaptive design two-part Phase II-III COVA study will evaluate Sarconeos in patients aged 45 years and above hospitalised with severe Covid-19 respiratory manifestations.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Infections and Infectious Diseases Product Name: BIO101
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 03, 2021
Details:
Part 1 of the COVA Study is a Phase 2 exploratory proof of concept study providing preliminary data on the safety, and tolerability and activity of Sarconeos (BIO101) in 50 hospitalized patients with severe respiratory manifestations related to COVID-19.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Infections and Infectious Diseases Product Name: BIO101
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 19, 2021
Details:
The COVA clinical study is a Phase 2/3, randomized, double-blind, placebo-controlled, adaptive and group sequential study assessing Sarconeos (BIO101) in patients aged 55 and older, infected with SARS-CoV-2.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Infections and Infectious Diseases Product Name: BIO101
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2020
Details:
Net proceeds of the private placement will be used to progress Biophytis drug development programs, including the COVA clinical study, for which Sarconeos obtained authorization to begin the Phase 2/3 clinical trial for COVID-19 in France, Brazil, Belgium, the UK and US.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Infections and Infectious Diseases Product Name: BIO101
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co
Deal Size: $11.7 million Upfront Cash: Undisclosed
Deal Type: Private Placement September 30, 2020
Details:
The COVA clinical program is a Phase 2/3, randomized, double-blind, placebo-controlled, adaptive and group sequential study assessing Sarconeos (BIO101) in patients infected with SARS-CoV-2.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Infections and Infectious Diseases Product Name: BIO101
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 01, 2020
Details:
French biotech firm Biophytis will assess its Sarconeos (BIO101) drug as a treatment for respiratory failure caused by Covid-19 after partnering with contract research organisation (CRO) SGS.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: BIO101
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biophytis
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership July 08, 2020
Details:
Net proceeds of the private placement will be used primarily to progress Biophytis drug development programs, including the COVA clinical study, To begin Sarconeos (BIO101) Phase 2/3 clinical trial as a potential treatment for respiratory failure associated with COVID-19.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: BIO101
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co., LLC
Deal Size: $6.8 million Upfront Cash: Undisclosed
Deal Type: Private Placement July 03, 2020
Details:
This pivotal, international clinical trial will be conducted in two parts, the first of which has the objective to assess treatment safety and provide an indication of activity of Sarconeos, in 50 hospitalized COVID-19 patients suffering from acute respiratory deficiency.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Infections and Infectious Diseases Product Name: BIO101
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: SGS Life Sciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2020
Details:
The COVA clinical program is designed to evaluate the efficacy and safety of Sarconeos (BIO101) as a treatment of the respiratory deterioration in COVID-19 patients with severe respiratory failure.
Lead Product(s): 20-Hydroxyecdysone
Therapeutic Area: Infections and Infectious Diseases Product Name: BIO101
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2020
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