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Clinical Trials

Date: 2014-11-06

Type of information: Presentation of results at a congress

phase: preclinical

Announcement: presentation of results at the 9th International Respiratory Syncytial Virus (RSV) Symposium, which is taking place from 9th to 13th November 2014 in Stellenbosch, South Africa

Company: Ablynx (Belgium)

Product: ALX-0171

Action mechanism:

ALX-0171 is a Nanobody product which binds to RSV and neutralizes the virus. This trivalent molecule is the first Nanobody to enter the clinic that will be administered through inhalation instead of injection. It nhibits RSV replication and neutralises RSV activity by blocking virus uptake into cells. The physical robustness of the Nanobody allows administration via inhalation directly to the site of infection, i.e. the respiratory tract including the lungs. ALX-0171 has shown a potent anti-viral effect against recent clinical RSV isolates. The Nanobody was well tolerated in multiple Phase I clinical studies in adults.

Ablynx is on track to start the first-in-infant Phase IIa study before the end of 2014.

Disease:

Respiratory Syncytial Virus (RSV) infections

Therapeutic area: Respiratory diseases - Infectious diseases

Country:

Trial details:

Latest news:

* On November 6, 2014, Ablynx announced that it will give an oral presentation on its first inhaled anti-RSV Nanobody®, ALX-0171, at the 9th International Respiratory Syncytial Virus (RSV) Symposium, which is taking place from 9th to 13th November 2014 in Stellenbosch, South Africa. The presentation will include results from the pre-clinical proof-of-concept study with ALX-0171 in a neonatal lamb model of RSV infection that is of relevance to RSV-infected infants. The results show that once-daily inhalation of ALX-0171 for three consecutive days resulted in a greater than 10,000-fold reduction of viral titres and markedly reduced lung inflammation. This treatment also rapidly alleviated various clinical signs and symptoms of the infection. These results are indicative of the encouraging potential of ALX-0171 in the treatment of RSV infection in infants - an area of high unmet medical need.

The neonatal lamb model is a highly relevant model for infant RSV infection because lambs develop comparable lower respiratory tract infections which are also associated with a decline in general well-being and specific lung pathology. In addition, lambs develop clinical symptoms that are similar to those that develop in infants, such as wheezing. In this proof-of-concept study, treatment with inhaled ALX-0171 was initiated at the peak of viral load (on the third day post-infection when the symptoms were already clearly present) in order to mimic the anticipated clinical situation with infected infants.

The presentation \"Delivery of ALX-0171 by inhalation greatly reduces disease burden in a neonatal lamb RSV infection model\" will take place on Thursday 13 November 2014.

Is general: Yes