The publication of the results of the Phase IIa clinical trial, evaluating ABX464 in hemorrhagic recto colitis, has been driving the stock market price of Montpellier biotech for nearly a year.
First, the results of the induction period (32 patients for two months) unveiled at the end of September 2018. That brought the Abivax action out of its torpor.
Then the first results, at nine months, of the maintenance study. Three months later, followed a capital increase of $12M exclusively subscribed by Sofinnova, via its Crossover fund.
In Phase IIb since August
Modestly described as “remarkable” in the press release, they are no less positive than the previous ones. Of the 19 patients who completed this maintenance study (out of 22), 16 accepted endoscopy. This examination revealed a clinical remission (total healing of the rectal mucosa) in 12 of them.
A consistent result with the evolution of other measures used in this autoimmune disease, including the rate of fecal calprotectin, a biomarker of intestinal inflammation, which decreased by 97% on average. This remission rate is also much higher than that observed with monoclonal antibodies usually prescribed in the late stages of the disease.
This product, a mainstay of Abivax’s portfolio, was in phase IIb since August. In a study planned for 252 patients with hemorrhagic recto colitis, intolerant or unresponsive to standard treatments. Researchers will evaluate three doses of ABX464 and the first results (two-month induction phase) will be ready by the end of 2020.
Abivax has changed significantly since its initial public offering. Back in 2015, the company became the champion of HIV (with ABX464, now dormant in this indication) and hepatitis B vaccination (with ABX203, in partnership with the Cuban IGBC, discontinued following disappointing clinical results in 2016).
But this biotech, built by the Truffle Capital investment fund, has undertaken a radical repositioning in the field of autoimmune diseases. And is now bearing fruit.
Suspended pending signature of a license agreement
In addition to hemorrhagic recto colitis, ABX 464 is in phase IIa in rheumatoid arthritis. The initial results will be ready in mid-2020. Also, soon in Crohn’s disease, where another phase IIa will begin before the end of the year.
ABX196, evaluated in phase IIa in liver cancer in combination with Opdivo, leads anti-cancer immunotherapy in the “checkpoint inhibitor” class. The first results of this test will be out in mid-2020.
Abivax remains suspended pending the signature of a licensing agreement for ABX464. It also remains in a precarious financial situation, with approximately eight months of financial autonomy.
The company had $11.6 million in net cash at the end of June, before Sofinnova’s refinancing. But it is precisely the strong support of this powerful investor that gives us hope. A solution, industrial or financial, will be found… to extend the suspense until the next clinical appointments.
The view of Kinam Hong, Partners at Sofinnova Partners
“Our Crossover I fund, dedicated to late-stage biotech, listed and unlisted, was launched in April 2018, with a €275m raise. Last July, Abivax was our 5th investment after Limflow (unlisted company), Inventiva, Gensight and Sensorion. We were impressed by the first results of ABX464 in phase IIa hemorrhagic recto colitis.
We found the results at the end of 2018. After several months of interaction with the company, investigation into the quality of science and clinical data, we decided to invest and join the Board of Directors. Today, we are opening up our privileged relationships to management at all levels: international investors, bankers and industrialists. These last results, published at the UEG Congress, would position the product as “best-in-class” in its indication.”
(Featured image by freestocks.org)
First published in Boursorama, a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.
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