Ablynx announced that, together with partner Merck-Serono, it has advanced a novel Nanobody, ALX-0761, into pre-clinical development for the treatment of autoimmune diseases. Ablynx will receive a € 1m milestone payment.
In a separate press-release, the company announced that it initiated the phase I study in healthy volunteers with ALX-0171, a Nanobody that can be inhaled for the treatment of RSV infections.
Our View:
ALX-0761 is the first pre-clinical candidate coming from the co-discover/develop collaboration with Merck-Serono that was initiated in 2008, and focused on two targets in immunology and oncology. While the target of ALX-0761 has not been disclosed, we would not be surprised if it would act on the popular inflammation targets IL-12/IL-23 to which Ablynx has filed patents. Ablynx said it may eventually enter the clinic together with Merck-Serono with the drug candidate.
The phase I study of ALX-0171 will be performed in a single centre and consists of 2 parts. The first single ascending dose part (testing 6 doses) will recruit 44 subjects, and will be followed by a multiple dose part recruiting 16 subjects. The results are expected in 3Q12.
With ALX-0171, Ablynx has a product candidate in hand that can proof the differentiation advantages of the Nanobody platform, allowing administration of antibody-like products via inhalation. Delivery via inhalation is an alternative and more convenient route of administration versus other antibody drugs which usually need to be injected.
RSV (respiratory syncytial virus) is still an area of high unmet medical need, especially in infants and elderly. There are no widely available therapies for the acute treatment of RSV, except in preventing RSV infections in high-risk infants. Ablynx’ ambition is to develop ALX-0171 to become the first-in-class therapeutic for the treatment of RSV. The product is unpartnered.
Conclusion:
We welcome the milestone payment of Merck-Serono. Although financially it is rather small, it shows the speed (3 years) at which Ablynx can generate new drug candidates. Moreover, it proofs the commitment of Merck-Serono in taking Nanobodies towards the clinic.
We believe that ALX-0171 can become a key driver in showing the competitiveness of the Nanobody platform. Of course, safety and efficacy via the pulmonary route will have to be demonstrated in the next 6-9 months, but once this threshold is passed, development cycling times for viral therapeutic agents can be substantially shorter than in other disease settings.
No changes to our Accumulate rating and target price.