The Spanish Agency of Medicines and Medical Devices (AEMPS) authorizes the start of the clinical trial of AP-2, Molefy Pharma’s therapeutic candidate for ALS 

AEMPS authorizes AP-2 clinical trial for ALS treatment led by Molefy Pharma

• The AEMPS authorizes the initiation of the Phase I clinical trial of AP-2, which will begin in April at Hospital Universitario de La Princesa with 70 healthy volunteers • AP-2, developed by Molefy Pharma based on CSIC research, targets the TDP-43 protein and has been granted orphan drug designation by the European Medicines Agency (EMA)  Molefy Pharma, a […]

A Canary Islands Company Leads the Clinical Trial of a New Drug to Treat ALS

Molefy Pharma researchers developing the AP-2 drug for ALS

Following the discovery of several molecules by a CSIC research group, Molefy Pharma will become one of the first organizations worldwide to evaluate the viability of this new therapeutic approach.  By Verónica Pavés. Santa Cruz de Tenerife. Originally published by El Día.  A company based in the Canary Islands will lead the clinical trial of a promising new treatment aimed […]

Molefy Pharma receives Orphan Drug Designation (ODD) from the European Union for its AP-2 candidate in the treatment of amyotrophic lateral sclerosis (ALS)

Scientific in laboratory

The European Medicines Agency (EMA) has granted Molefy Pharma the Orphan Drug Designation (ODD) for its candidate AP-2, an innovative therapy developed for the treatment of amyotrophic lateral sclerosis (ALS).  This designation is awarded to medicines with the potential to treat rare and severe diseases in the European Union, when they offer a significant benefit […]

ALS Association awards $1 million to Molefy Pharma to advance its clinical trial against ALS

Molefy Pharma's team

Spanish biotech company receives backing from one of the leading global organizations in the fight against amyotrophic lateral sclerosis (ALS) ARQUIMEA, Spanish technology group and co-founder of the spin-off Molefy Pharma together with researchers from the CSIC, celebrates the award of a $1 million grant from the ALS Association (ALS.org) to accelerate the development of […]

Molefy Pharma Showcased New ALS Research at ENCALS 2025 in Turin

Santa Cruz de Tenerife, 9 de junio de 2025. Molefy Pharma, a biotech company focused on developing innovative therapies for ALS and other neurodegenerative diseases, successfully presented three scientific papers at the ENCALS 2025 Meeting, held in Turin, Italy, reaffirming its commitment to advancing therapeutic innovation in Amyotrophic Lateral Sclerosis (ALS). The European Network to […]