Recursion is Granted EU Orphan Drug Designation for REC-4881 for the Potential Treatment of Familial Adenomatous Polyposis

Recursion is Granted EU Orphan Drug Designation for REC-4881 for the Potential Treatment of Familial Adenomatous Polyposis

 

PR Newswire



SALT LAKE CITY


,


July 21, 2022


/PRNewswire/ —


Recursion


(NASDAQ: RXRX), the clinical-stage biotechnology company industrializing drug discovery by decoding biology, today announced that the European Commission has granted Recursion Orphan Drug Designation for REC-4881 for the potential treatment of familial adenomatous polyposis (FAP). REC-4881 is an orally bioavailable, non-ATP-competitive allosteric small molecule inhibitor of MEK1 and MEK2 being developed to reduce polyp burden and progression to adenocarcinoma in FAP patients.

Recursion discovered REC-4881 as a potential candidate for treatment of FAP by leveraging its proprietary AI-powered drug discovery platform, the Recursion OS.

“FAP is a rare tumor syndrome that affects approximately 50,000 patients in the US,

France

,

Germany

,

Italy

,

Spain

and the UK, with no approved therapies”, said

Meredith Brown-Tuttle

, Vice President of Regulatory Affairs. “Recursion is excited about this Orphan Drug Designation in the European Union as we continue to advance towards initiating a Phase 2 clinical trial.”

Within the past 10 months, the U.S. Food and Drug Administration (FDA) granted the company Orphan Drug and Fast Track designations for REC-4881 to support the development and evaluation of new treatments for FAP.

Learn more about Recursion at


https://www.recursion.com/


.


About REC-4881

REC-4881 is an orally bioavailable, non-ATP-competitive allosteric small molecule inhibitor of MEK1 and MEK2 being developed to reduce polyp burden and progression to adenocarcinoma in FAP patients. REC-4881 has been well tolerated in prior clinical studies, consistent with the intended use, and has a gut-localized PK profile that may be advantageous for FAP, and potentially other APC-driven gastrointestinal tumors. We expect to initiate a Phase 2, double-blind, randomized, placebo-controlled clinical trial of REC-4881 in FAP by the end of this quarter.


About Familial Adenomatous Polyposis

FAP is a rare tumor syndrome with no approved therapies. In the US,

France

,

Germany

,

Italy

,

Spain

and the UK alone the disease affects approximately 50,000 patients. FAP is caused by autosomal dominant inactivating mutations in the tumor suppressor gene APC. FAP patients develop polyps in the gastrointestinal tract throughout their lives. These growths have a high risk of malignant transformation and can give rise to invasive cancers of the colon, stomach, duodenum, rectum, and other tissues. Standard of care for patients with FAP is colectomy, and without surgical intervention, affected patients will progress to colorectal cancer in adulthood. Even after colectomy, patients receive endoscopic surveillance every 6-12 months to monitor disease progression. While surgical management and surveillance have improved the prognosis for FAP patients, duodenal and desmoid tumors remain major causes of death following colectomy in patients with FAP.


About Recursion



Recursion


is the clinical-stage biotechnology company industrializing drug discovery by decoding biology. Enabling its mission is the Recursion Operating System, a platform built across diverse technologies that continuously expands one of the world’s largest proprietary biological and chemical datasets, the Recursion Data Universe. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset the Recursion Map, a collection of hundreds of billions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.

The Company is headquartered in

Salt Lake City

, where it is a founding member of


BioHive


, the

Utah

life sciences industry collective. Recursion also has offices in

Toronto

, Montréal and the

San Francisco Bay Area

. Learn more at


www.Recursion.com


, or connect on


Twitter


and




LinkedIn


.


Media Contact



[email protected]


Investor Contact



[email protected]


Forward-Looking Statements

This press release contains information that includes or is based upon “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements provide our expectations or forecasts regarding future events. You can identify these statements by the fact they do not relate strictly to historical or current facts. They may use words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” and other terms of similar meaning in connection with a discussion of future operating or financial performance. In particular, forward-looking statements include statements relating to intended future actions; plans with respect to clinical trials and preclinical activities; prospective products or product approvals; future performance or results of anticipated products or technology; expenses; our ability to obtain, maintain and enforce intellectual property protections; and financial results, in addition to other topics. Any or all of our forward-looking statements here and elsewhere may turn out to be wrong. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements and from expected or historical results. Many such factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed. In particular, you should read the discussion in the “Risk Factors” section in our Prospectus filed with the U.S. Securities and Exchange Commission (SEC) on

April 16, 2021

as well as in our Form 10-K filed with the SEC on

March 23, 2022

and our other periodic filings with the SEC. Other factors besides those listed could also adversely affect the company. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future developments or otherwise, except to the extent required by applicable law. These forward-looking statements (except as may be otherwise noted) speak only as of the date of this press release. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. You are advised to consult any further disclosures we make on related subjects in our reports to the SEC.

Cision
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