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Thursday, September 19, 2024

Lose Fats, Not Muscle: Subsequent Check for Lilly’s Zepbound Pairs It With BioAge Drug


One concern in regards to the GLP-1 class of metabolic dysfunction medicine is that the load sufferers lose contains muscle in addition to fats. BioAge Labs desires to check whether or not its experimental medicine, dosed alongside Eli Lilly’s weight administration drug Zepbound, can protect muscle mass. The startup not too long ago closed $170 million to finance a mid-stage scientific trial.

BioAge develops medicine that tackle features of human getting older. Its lead drug candidate, azelaprag, is a small molecule designed to bind to and activate the apelin receptor, which regulates muscle metabolism, progress, and restore. This drug got here from the labs of Amgen, which initially developed it for treating coronary heart failure.

Amgen’s Section 1 checks confirmed the drug hit its goal with a clear security profile, BioAge CEO Kristen Fortney instructed MedCity Information in a 2022 interview. However as a coronary heart drug, the outcomes have been “not dramatic,” she stated. Amgen elected to shelve the molecule. Richmond, California-based BioAge licensed it from the pharma big in 2021, with the aim of testing it as a manner of preserving muscle mass in aged individuals.

In BioAge’s Section 1b research enrolling 21 individuals age 65 and older, outcomes confirmed the experimental drug led to statistically vital prevention of muscle atrophy relative to a placebo after 10 days of mattress relaxation. The corporate deliberate to proceed to bigger Section 2 take a look at enrolling intensive care unit sufferers, who can lose  greater than 15% of their muscle mass in only one week, in accordance with revealed analysis. Final fall, BioAge introduced the Section 2 trial would go in a distinct route. As an alternative of testing azelaprag in ICU sufferers, the trial will consider the drug alongside Eli Lilly’s Zepbound. The injectable drug, which prompts the GLP-1 and GIP receptors, is an incretin mimetic, a kind of drug that works by mimicking hormones discovered within the intestine.

The brand new scientific trial plan relies on preclinical analysis in overweight mice. Outcomes reported final 12 months confirmed that treating the mice with each azelaprag and Lilly’s drug led to better weight reduction than what was achieved with the Lilly drug alone. The drug pairing additionally led to enchancment in physique composition and muscle operate. Below a collaboration settlement, Lilly will provide Zepbound for BioAge’s trial, which will probably be run in collaboration with Refrain, a small impartial scientific growth group throughout the pharma big.

BioAge adjusted its focus for azelaprag after the corporate’s expertise uncovered new perception in regards to the molecule. The BioAge discovery platform, constructed on evaluation of human longevity information, recognized a hyperlink between the apelin pathway exercise and bodily operate throughout getting older, Fortney stated in an electronic mail. Whereas the Section 1b scientific trial led to outcomes displaying vital muscle and metabolic advantages in wholesome aged volunteers on mattress relaxation, the molecule’s mechanism has a number of potential purposes, Fortney stated.

“Weight problems is the indication we’re specializing in given the robust weight reduction synergy we see preclinically with incretins,” she stated. “That is an oral drug with the potential to extend weight reduction amount with a completely oral routine, in addition to to enhance weight reduction high quality.”

Fortney stated BioAge will share extra particulars on the design of the Section 2 trial sooner or later, however the research will evaluate azelaprag (identified at BioAge as BGE-105) together with Zepbound versus Zepbound alone. The first endpoint will probably be weight reduction. As well as, the corporate will monitor exploratory endpoints associated to enchancment of physique composition—the stability of lean mass to fats mass.

BioAge’s new capital will finance the deliberate Section 2 take a look at, which is on monitor to start out in mid-2024. The Collection D spherical was led by Sofinnova Investments. New buyers becoming a member of the financing embody Longitude Capital, RA Capital Administration, Cormorant Asset Administration, RTW Investments, SV Well being Traders, OrbiMed Advisors, Sands Capital, Pivotal bioVenture Companions, Osage College Companions, Lilly Ventures, and Amgen Ventures. The newest spherical additionally included participation from earlier investor Andreessen Horowitz.

Right here’s a have a look at different latest life science trade financing exercise:

—Frontier Medicines, developer of focused medicines for oncology and immunology, closed $80 million in financing to help its pipeline. The biotech’s most superior program is FMC-376, which is in growth for treating sufferers whose most cancers is optimistic for KRAS G12C. This mutation was first drugged by Lumakras from Amgen after which Krazati from Mirati Therapeutics. Each medicine lock KRAS G12C protein in an inactive state. Frontier’s drug candidate is designed to dam this cancer-driving protein in both its energetic or inactive states, doubtlessly providing an choice for sufferers who haven’t responded to the Amgen or Mirati medicine.

Along with supporting FMC-376, which not too long ago dosed the primary affected person in a Section 1/2 research, Frontier stated the brand new capital will help different wholly owned packages in its pipeline. Deerfield Administration Firm and Droia Enterprise co-led the corporate’s Collection C financing, which additionally included “vital participation” by Belgium-based drugmaker Galapagos. Frontier final raised cash in 2021, an $88.5 million Collection B spherical.

Firefly Bio revealed $94 million to finance R&D of degrader antibody conjugates, or DACs, which carry a protein degrader because the drug payload. In preclinical analysis, the biotech stated its medicine led to “vital discount of tumor quantity at very low doses.” Firefly was incubated by Versant Ventures, which co-led the startup’s Collection A financing with MPM BioImpact.

—Roche, already an investor in liquid biopsy firm Freenome, led an further $254 million financing for the corporate. South San Francisco-based Freenome will apply the money towards ongoing pivotal scientific trials evaluating its blood screening expertise in colorectal most cancers and lung most cancers. The corporate can also be conducting a research of its expertise as a strategy to detect a number of cancers. Roche final invested in Freenome two years in the past, a $290 million infusion that adopted the corporate’s $300 million Collection D financing.

—Latigo Biotherapeutics launched with $135 million to finance scientific growth of a non-opioid drug that blocks NaV1.8, a sodium channel related to ache. It’s the identical goal addressed by a Vertex Prescription drugs drug candidate that not too long ago posted information displaying it met its fundamental Section 3 aim assessing ache reduction in comparison with a placebo. However on a secondary aim of displaying superiority to straightforward of care Vicodin, the Vertex drug got here up brief.

Thousand Oaks, California-based Latigo claims its drug might be finest within the class of NaV1.8 inhibitors with speedy onset, significant efficacy, and superior security. It’s at the moment in Section 1 testing. Latigo’s Collection A financing was led by Westlake Village BioPartners, which incubated the startup.

—Most cancers immunotherapy developer NextPoint Therapeutics added $42.5 million to its Collection B financing, bringing the spherical’s whole to $122.5 million. The medicine of Cambridge, Massachusetts-based NextPoint goal the HHLA2 pathway. NextPoint first introduced its Collection B spherical final 12 months.

—Sudo Biosciences expanded its Collection B financing by $31 million, bringing the spherical’s whole to $147 million. The brand new buyers are Dementia Discovery Fund, Leaps by Bayer, and UPMC Enterprises. Carmel, Indiana-based Sudo emerged from stealth in 2022 to develop small molecule medicine that tackle TYK2, an autoimmune illness goal first hit by the Bristol Myers Squibb drug Sotyktu.

—Alys Prescription drugs launched with $100 million from Medicxi, the funding agency that fashioned the corporate. The preclinical biotech, which focuses on creating remedies for immune problems of the pores and skin, was fashioned by combining six Medicxi portfolio corporations. Goal indications embody atopic dermatitis, vitiligo, psoriasis, and mastocytosis.

—Antibody drug conjugate developer ProfoundBio closed $112 million in financing, which will probably be utilized to scientific growth of its pipeline. Lead program rinatbart sesuctecan, or Rina-S, targets folate receptor alpha, a validated most cancers goal. A pivotal Section 1/2 research is underway in ovarian most cancers. Ally Bridge Group led the Seattle-based biotech’s Collection B spherical. ProfoundBio, whose administration group brings expertise from ADC specialist Seagen, emerged in 2021 backed by a $55 million Collection A financing.

—Areteia Therapeutics expanded its Collection A spherical by $75 million with the addition of latest buyers Viking World Traders and Marshall Wace. The Chapel Hill, North Carolina-based biotech’s Collection A financing was introduced at $350 million in 2022. Lead drug candidate dexpramipexole comes from the labs of Knopp Biosciences. Areteia is at the moment testing the molecule in three Section 3 scientific trials enrolling sufferers with eosinophilic bronchial asthma, a extreme type of bronchial asthma.

—Basking Biosciences raised $55 million in a financing led by Arch Enterprise Companions. Columbus, Ohio-based Basking will use the capital to proceed scientific growth of BB-031, a possible therapy for acute ischemic stroke. The Basking drug is a reversible RNA aptamer designed to focus on von Willebrand issue, a clotting protein. BB-031 is engineered for each speedy onset and brief period of impact. Basking plans to start out Section 2 testing later this 12 months.

—Neurona Therapeutics, developer of regenerative medicines for neurological problems, closed $120 million in financing. The San Francisco-based biotech makes cell therapies from human pluripotent stem cells, which have the power to turn into virtually any kind of cell. Neurona will apply the capital towards ongoing Section 1/2 testing of NRTX-1001, developed as a one-time therapy to silence epileptic seizures. Viking World Traders and Cormorant Asset Administration co-led Neurona’s Collection E spherical.

—Cour Prescription drugs has already out-licensed a celiac illness therapeutic candidate to Takeda Prescription drugs, which has superior the nanoparticle-based remedy to Section 2 testing. Chicago-based Cour desires to develop its personal drug candidates and it raised $105 million to help packages in kind 1 diabetes and myasthenia gravis. Lumira Ventures and Alpha Wave Ventures co-led the Collection A financing, which included participation from three large pharma corporations.

—Eyconis, a brand new firm fashioned with belongings from Ascendis Pharma, launched with a $150 million financing dedication from an investor syndicate that features Frazier Life Sciences, RA Capital Administration, venBio, and HealthQuest Capital. Eyconis, which is able to function from Redwood Metropolis, California, has ophthalmology belongings developed from Ascendis’s Transcon platform. Ascendis, which has an fairness stake in Eyconis, granted the biotech rights to develop and commercialize Transcon ophthalmology merchandise globally.

—Synnovation Therapeutics, based and led by veterans of Incyte, launched with $102 million for small molecule medicine addressing validated most cancers targets. Lead program SNV1521 is a PARP1 inhibitor that’s extremely selective to that concentrate on and in addition has the power to penetrate into the central nervous system. The Wilmington, Delaware-based firm is testing this molecule in a Section 1 scientific trial. Third Rock Ventures led Synnovation’s Collection A financing, which included participation from Nextech, Lilly Asia Ventures, Sirona Capital, and Cormorant Asset Administration.

Picture by Eli Lilly

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