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First Wave BioPharma Completes Merger Deal With ImmunogenX Adding Phase 3-Ready Candidate For Celiac Disease

First Wave BioPharma Completes Merger Deal With ImmunogenX Adding Phase 3-Ready Candidate For Celiac Disease

First Wave BioPharma完成了與ImmunoGenx的合併協議,增加了針對乳糜瀉的第三階段就緒候選藥物
Benzinga ·  03/14 18:00

First Wave BioPharma Inc (NASDAQ:FWBI) has acquired ImmunogenX in an all-stock transaction with the combined company focused on advancing a gastrointestinal (GI) pipeline.

First Wave BioPharma Inc(納斯達克股票代碼:FWBI)已通過全股交易收購了ImmunoGenX,合併後的公司專注於推進胃腸道(GI)管道。

First Wave BioPharma signed a non-binding term sheet in December to acquire ImmunogenX.

First Wave BioPharma在12月簽署了一份不具約束力的條款表,以收購ImmunoGenx。

James Sapirstein will continue to serve as Chairman and CEO of First Wave BioPharma, with Dr. Jack Syage, previously the CEO and Co-Founder of ImmunogenX, assuming the role of President and Chief Operating Officer of First Wave BioPharma.

詹姆斯·薩皮爾斯坦將繼續擔任第一浪生物製藥的董事長兼首席執行官,前ImmunoGenx首席執行官兼聯合創始人傑克·賽格博士將擔任第一浪生物製藥的總裁兼首席運營官。

First Wave BioPharma intends to license the commercial rights to latiglutenase in the U.S. and Canada to a global pharmaceutical company.

First Wave BioPharma打算將美國和加拿大的latiglutenase的商業權利許可給一家全球製藥公司。

It will also seek to secure financing commitments from a syndicate of institutional healthcare investors in the second half of 2024 to fund the ongoing development of latiglutenase.

它還將尋求在2024年下半年獲得機構醫療保健投資者集團的融資承諾,爲latiglutenase的持續開發提供資金。

"We expect to finalize these agreements prior to initiating preparatory work for the Phase 3 latiglutenase trials," Sapirstein said.

薩皮爾斯坦說:“我們希望在啓動3期拉提谷蛋白酶試驗的準備工作之前敲定這些協議。”

Latiglutenase, an oral biotherapeutic composed of two gluten-specific recombinant proteases, has demonstrated effectiveness in reducing intestinal damage and alleviating symptoms of celiac disease in two Phase 2 trials involving approximately 200 patients.

Latiglutenase是一種由兩種麩質特異性重組蛋白酶組成的口服生物療法,在涉及約200名患者的兩項2期試驗中,已證明可有效減少腸道損傷和緩解乳糜瀉症狀。

The Phase 3 clinical plan for latiglutenase has been reviewed by the GI Division of the FDA, and the trials are anticipated to begin in early 2025 compared to 2H of 2024 expected earlier.

Latiglutenase的3期臨床計劃已經過美國食品藥品管理局胃腸道部的審查,這些試驗預計將於2025年初開始,而早些時候預計的2024年下半年開始試驗。

"Completion of the acquisition of ImmunogenX and the addition of latiglutenase to our clinical pipeline is a transformative event for First Wave BioPharma as it provides our company with a Phase 3-ready asset in a multibillion-dollar GI market – celiac disease – for which no approved pharmacologic treatment currently exists," Sapirstein added.

薩皮爾斯坦補充說:“完成對ImmunoGenX的收購以及將latiglutenase添加到我們的臨床產品線中是First Wave BioPharma的變革性事件,因爲它爲我們公司提供了價值數十億美元的胃腸道市場——乳糜瀉——的三期就緒資產,該市場目前尚無經批准的藥物治療方法。”

Upon closing the acquisition, the company issued 365,162 shares of its common stock to the shareholders of ImmunogenX, equal to 19.02% of its currently issued and outstanding common stock and 11,777.418 shares of its newly issued Series G Convertible Preferred Stock.

收購完成後,該公司向ImmunogenX的股東發行了365,162股普通股,相當於其當前已發行和流通普通股的19.02%,以及其新發行的G系列可轉換優先股的11,777.418股。

In December, First Wave BioPharma entered a non-binding term sheet to sell its Niclosamide program for treating inflammatory bowel diseases.

12月,First Wave BioPharma發佈了一份不具約束力的條款表,出售其治療炎症性腸病的尼氯沙胺計劃。

Price Action: FWBI shares closed at $6.53 on Wednesday.

價格走勢:FWBI股價週三收於6.53美元。

譯文內容由第三人軟體翻譯。


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