After Disappointing Phase 2 Data, Merck Drops Eye Disease Related Pact With NGM Biopharm – NGM Biopharmac

Ii months after NGM Biopharmaceuticals’ drug candidate for a vision-loss disorder failed its mid-phase test, partner Merck is dissociating from that program and others covered past a multi-year research brotherhood during which the pharmaceutical giant has paid virtually $600 million.

The failed drug candidate, NGM621, was in development for geographic atrophy, a disorder that initially leads to deterioration of a patient’s fundamental vision that tin eventually progress to total blindness. In a regulatory filing, NGM said Merck verbally told the company it volition not practise its option to license NGM621 and compounds related to that drug candidate.

The collaboration understanding had given the Merck the choice to license NGM621 bundled with other preclinical ophthalmology compounds, but the pharma company said it volition non exercise that option either. The detect to South San Francisco-based NGM comes i calendar month earlier the expiration date of the option.

NGM’south Merck collaboration, which began in 2015, initially spanned a wide range of therapeutic areas. The pharma giant paid $94 million up front and fabricated a $106 million disinterestedness investment in the biotech. The deal likewise called for Merck to make additional payments to cover R&D over the course of the agreement. Merck did exercise an selection to develop ane program from the alliance, the nonalcoholic steatohepatitis (NASH) drug candidate NGM313. Now renamed MK-3655, the antibody drug is currently in Stage 2 testing under Merck.

Terminal year, NGM and Merck restructured their alliance to focus on ophthalmology and cardiometabolic disorders. The restructured deal extended the research phase of the pact through the get-go quarter of 2024. The amended deal gave Merck the choice to license compounds upon the completion of a human proof-of-concept study.

Geographic atrophy is characterized by harm to the macula, which is function of the retina. In that location are no drugs for the vision-loss disorder, which is associated with excessive activity of the complement system, a office of the allowed system. NGM621 is an antibody designed to block the complement system poly peptide C3. NGM was in the mix with Apellis Pharmaceuticals and others developing drugs that block complement arrangement proteins in order to boring the progression of geographic atrophy (an FDA determination for the Apellis drug, pegcetacoplan, is expected past late February).

The 320-patient Phase ii test of NGM621 compared information technology to a sham injection. Despite failing to meet the main goal of showing a modify in the retinal lesions that class from geographic cloudburst, the biotech had noted that fewer patients in the treatment arm adult the growth of new blood vessels in the eye that contributes to vision loss. Furthermore, the company said excluding the patients who had the largest lesions at the study’south baseline showed greater reductions in lesions over the course of 52 weeks of treatment. If NGM has since found anything promising from its reanalysis of the trial data, information technology did not say. Regardless, Merck decided not to pursue anything farther with NGM621 or NGM’s other eye programs.

NGM has fallen brusk with some of its internal R&D. Its wholly owned NASH program, a drug candidate called aldafermin, failed a Phase 2 test last yr. The remainder of NGM’s pipeline is in oncology. The nigh advanced of the five cancer programs is NGM120, an antibiotic drug currently in mid-stage testing in metastatic pancreatic cancer and cachexia.

Through the end of September, Merck had paid NGM $599.viii million under the collaboration, according to the company’s 3rd quarter financial report. If the company’s geographic atrophy drug candidate has whatsoever future, NGM must find someone else to foot the bill. In the quarterly study, NGM said if Merck does not exercise its option on the program, “which information technology may make up one’s mind given that the Phase 2 CATALINA trial did not meet its primary endpoint, nosotros would need to partner the program in order to proceed with further evolution of NGM621, if any.”

The financial report lists $101.4 million in greenbacks and greenbacks equivalents, and $198.7 1000000 in short-term marketable securities. NGM said in the filing that information technology believes those funds will be enough to support the visitor for at least 12 months.

Photo: Karen Bleier/AFP, via Getty Images


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