- PHASE I CLINICAL TRIAL INITIATED TO EVALUATE SEMA3A MAB AS POTENTIAL TREATMENT FOR ALPORT SYNDROME
- FIRST DOSING OF FIRST STUDY PARTICIPANT TRIGGERS MILESTONE PAYMENT OF € 2 M TO EVOTEC
Hamburg, Germany, 29 June 2023:
Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) announced today that it is to receive a € 2 m milestone payment from Bayer AG, which is triggered by the first patient dosed in the clinical Phase I study of a kidney disease programme stemming from the Evotec-Bayer multi-target research collaboration in kidney diseases. The drug candidate, a monoclonal antibody (“mAb”) targeting the protein Semaphorin-3A (“Sema3A”) is being developed as a potential first-to-market treatment for Alport syndrome, a rare genetic kidney disease.
The Phase I clinical evaluation of the Sema3A mAb was initiated in June 2023, including dosing of the first healthy study participant.
The programme originates from a strategic collaboration, which Evotec and Bayer entered in September 2016. Under the terms of the agreement, Evotec is eligible to receive further significant clinical and sales milestones as well as tiered royalties of net sales depending on the future progress during clinical development and potential commercialisation of a drug in the future.
Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: “We are excited that Bayer is moving ahead with the Phase I clinical development of an asset from our multi-target research alliance in kidney diseases. Novel clinical candidates that build on an improved understanding of chronic kidney diseases are urgently needed to effectively treat the broad range of disease phenotypes we see in this area. The jointly developed monoclonal antibody targeting Sema3a constitutes such novel clinical candidate that may, subject to its further clinical evaluation, potentially deliver a much-needed therapeutic option for patients living with Alport syndrome.”
Semaphorin-3A (“Sema3A”) is an extracellular guidance protein and a well-known regulator of the actin cytoskeleton. Alterations of the actin cytoskeleton, particularly of podocytes, are a key pathophysiological feature of Alport syndrome, a rare genetic kidney disease with progressive loss of filtration capacity, leading to end stage renal disease, progressive hearing loss and variable vision impairment. Sema3A is upregulated in injured human kidneys and implicated in the development and progression of acute and chronic kidney diseases. The monoclonal antibody (“mAb”) developed by Bayer in partnership with Evotec blocks Sema3A activity and offers first-to-market potential to treat Alport syndrome, aiming to delay disease progression and onset of end-stage renal disease, with a potentially positive impact on hearing loss.
About Alport Syndrome
Alport syndrome is a genetic condition characterised by kidney disease, hearing loss, and eye abnormalities. Most affected individuals experience progressive loss of kidney function, which may lead to end-stage kidney disease. People with Alport syndrome also frequently develop sensorineural hearing loss in late childhood or early adolescence. The eye abnormalities characteristic of this condition seldom lead to vision loss. In 80% of cases, Alport syndrome is inherited in an X-linked manner and is caused by genetic changes in the COL4A5 gene. In the remaining cases, it may be inherited in either an autosomal recessive, or rarely in an autosomal dominant manner. In these cases, the condition is caused by genetic changes in the COL4A3 or COL4A4 genes. Diagnosis of the condition is based on family history of the condition, clinical signs, and specific testing such as a kidney biopsy. The diagnosis can be confirmed by genetic testing.