TheraVet Announces Positive Safety and Efficacy Results for VISCO-VET in Canine Osteoarthritis

With a single VISCO-VET single intra-articular injection:

• Statistically significant improvement of dog’s mobility
• Statistically significant reduction of dog’s osteoarthritis-related pain
• Effects lasting (and increasing over) up to 3 months after injection
• Well tolerated with no adverse event reported

JUMET, Belgium--(BUSINESS WIRE)--Regulatory News:

TheraVet (Paris:ALVET) (Brussels:ALVET) (ISIN: BE0974387194 - ticker: ALVET), a pioneering company in the management of osteoarticular diseases in pets, today announces positive safety and efficacy results of its PoC (Proof-of-Concept) clinical study assessing VISCO-VET in canine osteoarthritis.

VISCO-VET: a new potential therapeutic option for canine osteoarthritis

VISCO-VET, TheraVet’s viscoregenerative gel, was assessed in a PoC prospective noncontrolled clinical study in client-owned dogs suffering from osteoarthritis (OA). Dogs were treated by a unique intra-articular injection and followed up monthly for 3 months. Twenty (20) dogs were included and sixteen (16) completed the study composing the Intention-to-treat (ITT) population. The main objectives of the study were to assess the effects of VISCO-VET on dog’s mobility by using validated owner questionnaires LOAD (Liverpool OsteoArthritis in Dogs) and on OA-related pain by using validated owner questionnaires CBPI (Canine Brief Pain Inventory)¹.

A single VISCO-VET intra-articular injection improved statistically significantly the dog’s mobility as measured by the LOAD score with a decrease of 27.4% (p<0.05) at 3 months as compared to baseline. The improvements were already observed at 1 and 2 months (respectively, -15.7% (p>0.05) and -21.8% (p<0.05)), demonstrating the increase in efficacy of VISCO-VET over time and its long-term effect on dog’s mobility.

Also, a single VISCO-VET intra-articular injection induced a statistically significant reduction of osteoarthritis-related pain in dogs. Indeed, VISCO-VET induced a decrease of the PSS as soon as 1 month (p<0.001) and was maintained up to 3 months with a decrease of 32.9% as compared to baseline (p<0.01). Similarly, VISCO-VET induced a statistically significant decrease of the PIS as soon as 1 month (p<0.01) and was maintained up to 3 months with a decrease of 29.7% (p<0.01) as compared to baseline. Moreover, Quality of Life score was unchanged or improved in 87.5% of the dogs. Similar trend on CBPI scores was observed in the PP population with but the difference was not statistically significant due to the too small sample size.

Similar levels of OA-related pain reduction were reported with the OA registered medications but these effects were limited to 28 days (approved treatment duration), while they were lasting at least for 3 months with VISCO-VET after a single intra-articular injection.

VISCO-VET was also well-tolerated with no side-effects related to the product reported during the course of the study and is therefore well positioned as compared to OA approved medications. For example, the leader OA medication is associated with 41% side-effects (mainly gastrointestinal, e.g., vomiting, soft-formed or mucous faeces, diarrhoea and inappetence).

Together, the results of this PoC study demonstrate the long lasting and statistically significant effects of VISCO-VET in improving mobility and in reducing pain in dogs with osteoarthritis for up to 3 months after a single intra-articular injection.

As compared to available OA treatments, VISCO-VET displays key differentiating characteristics that may explain its long acting effects. Besides hyaluronic acid known for its viscosupplementation properties, VISCO-VET is optimally loaded in active molecule controlling OA inflammatory process and contains canine allogeneic plasma allowing its intra-articular gelification to act as a slow release formulation.

Pr. Balligand, Principal investigator and Head of the Department of Surgery for companion animals of the Veterinary Clinic at the University of Liège (CVU, Belgium): “Many patients have undisputedly benefited from this treatment during up to 3 months, to the very satisfaction of their owner even if some patients did not favourably respond as much and long as expected by the owners. Comfort was clearly increased allowing a higher level of painfree physical activities and eventually a better life. More treated cases should allow to confirm the favourable outcome observed in this encouraging preliminary clinical trial.”

Enrico Bastianelli, Chief Executive Officer of TheraVet, concludes: “The results of VISCO-VET in such a disabling chronic disease are very promising. VISCO-VET provides to veterinarians a potential new therapeutic option to improve dog’s mobility and quality of life for up to 3 months with a positive safety profile. VISCO-VET may become a game changer in a field where current treatments are intended to control OA-related pain only for 1 month or less and may be associated to serious side effects”.

Next financial updates

• Half-year Financial Results of 2021, on September 22, 2021

About TheraVet SA

TheraVet is a veterinary biotechnology company specialising in osteoarticular treatments for animals. The Company develops targeted, safe and effective treatments to improve the quality of life of pets suffering from osteoarticular diseases. For pet owners, the health of their pets is a major concern and TheraVet’s mission is to address the need for innovative and curative treatments. TheraVet works closely with international opinion leaders in order to provide a more effective response to ever-growing needs in the field of veterinary medicine. TheraVet is listed on Euronext Growth® Paris et Brussels, its head office is in Jumet, Belgium, and it has a subsidiary in the US.
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¹ CBPI is composed of 3 score components: Pain Severity Score (PSS) and Pain Interference Score (PIS) and a score of Quality of Life (QoL)

TheraVet
Sabrina Ena
Chief Operating Officer
sabrina.ena@thera.vet
Tel: +32 (0) 71 18 32 49

Julie Winand
Chief Corporate Officer
julie.winand@thera.vet
Tel: +32 (0) 71 18 32 49

NewCap
Investor Relations and Financial Communications
Louis Tilquin / Olivier Bricaud
theravet@newcap.eu
Tel: +33 (0)1 44 71 94 94

Press Relations
Arthur Rouillé / Ambre Delval
theravet@newcap.eu
Tel: +33 (0)1 44 71 00 15