Zeltia subsidiary Sylentis commences Phase I trials with its new compound SYL1001 to treat eye pain associated with dry eye syndrome

  • SYL1001 is a new compound arising from Sylentis’s research in ophthalmological disorders
  •  It is indicated for treating eye discomfort associated with dry eye syndrome
  •  SYL1001 is a form of interference RNA (RNAi)
  •  SYL1001 inhibits the capsaicin receptor TrpV1, which is expressed on the surface of the eye

Madrid, 6 June 2011: Sylentis, a biopharmaceutical subsidiary of Grupo Zeltia (MC: ZEL) and a pioneer in the research and development of new drugs based on gene silencing (interference RNA, RNAi), has received authorisation from the Spanish Medicines and Health products Agency to commence clinical trials with SYL1001 for treating or preventing eye discomfort.

The endpoint of the Phase I trial is to determine the compound’s safety and tolerance in healthy volunteers. This is Sylentis’s third clinical trial using RNAi technology and its second compound to enter clinical trials, evidencing the company’s commitment to developing innovative compounds to treat eye diseases. Sylentis is the first company in Spain and one of only four companies in the world with RNAi-based products in clinical trials.

The Phase I trial with SYL1001 will be performed on healthy volunteers at the Navarra University Clinic.

About SYL1001

SYL1001 DP is presented in the form of eye drops for treating or preventing eye discomfort associated with dry  eye, Sjögren’s and other syndromes, and with corneal injuries, with a view to minimising pain and improving patients’ quality of life. SYL1001 eye drops is a sterile, isotonic saline solution presented in single-dose vials, eliminating the need for antimicrobial preservatives.

About Sylentis

Sylentis was founded in 2006 as a spin-off from Grupo Zeltia subsidiary Genómica, S.A.U. In January 2011, Sylentis received authorisation from the Spanish Agency of Medicines and Medical Devices (AEMPS) as a drug manufacturing facility, strengthening its position as a pioneer in Spain in the search for new therapies based on RNAi. The company aims to design effective short interfering RNAs (siRNAs) using bioinformatic programmes such as SIRFINDER®, which optimises the design of siRNAs with pharmacological potential. Sylentis initially focused on developing therapies to treat glaucoma/ocular hypertension, conditions which are addressed by the company’s most advanced compounds at present. It also has other research lines whose compounds are in the R&D and preclinical phases.

About interference RNA (RNAi)

RNAi has arisen in recent years as a promising technology with therapeutic applications, and was recognised worldwide when its discoverers, Fire and Mello, received the Nobel Prize in 2006. Discovered in plants in the 1990s, RNAi consists of highly efficient selective and specific inhibition of gene expression. RNAi is mediated by small fragments of double-stranded RNA, consisting of 19-23 nucleotides, which promote degradation of messenger RNA (mRNA), thus inhibiting synthesis of the proteins for which they code and which are responsible for the pathology. RNAi therapy has great potential as this mechanism is used naturally by cells to regulate gene expression in a way that is both non-toxic and highly effective.

Important note

Sylentis, which is headquartered in Madrid (Spain), is a subsidiary of Grupo Zeltia (Spanish stock exchange: ZEL), which has been listed on the Spanish Stock Exchange since 1963 and on Spain’s Electronic Market since 1998. This document is a press release, not a prospectus. This document does not constitute or form part of an offering or invitation to sell or a solicitation to purchase, offer or subscribe shares of the company. Moreover, no reliance should be placed upon this document for any investment decision or contract and it does not constitute a recommendation of any type with regard to the shares of the company.

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