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

One concern concerning the GLP-1 class of metabolic dysfunction medicine is that the burden sufferers lose contains muscle in addition to fats. BioAge Labs needs to check whether or not its experimental treatment, 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 deal with points of human getting old. 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 Part 1 assessments confirmed the drug hit its goal with a clear security profile, BioAge CEO Kristen Fortney advised MedCity Information in a 2022 interview. However as a coronary heart drug, the outcomes had 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 method of preserving muscle mass in aged folks.

In BioAge’s Part 1b research enrolling 21 contributors 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 Part 2 check enrolling intensive care unit sufferers, who can lose  greater than 15% of their muscle mass in only one week, in line with printed analysis. Final fall, BioAge introduced the Part 2 trial would go in a distinct path. 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. Underneath a collaboration settlement, Lilly will provide Zepbound for BioAge’s trial, which shall be run in collaboration with Refrain, a small impartial scientific growth group inside the pharma big.

BioAge adjusted its focus for azelaprag after the corporate’s expertise uncovered new perception concerning 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 old, Fortney stated in an electronic mail. Whereas the Part 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 functions, Fortney stated.

“Weight problems is the indication we’re specializing in given the sturdy 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 Part 2 trial sooner or later, however the research will evaluate azelaprag (recognized at BioAge as BGE-105) together with Zepbound versus Zepbound alone. The first endpoint shall be weight reduction. As well as, the corporate will monitor exploratory endpoints associated to enchancment of physique composition—the steadiness of lean mass to fats mass.

BioAge’s new capital will finance the deliberate Part 2 check, 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 embrace Longitude Capital, RA Capital Administration, Cormorant Asset Administration, RTW Investments, SV Well being Buyers, 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 take a look at different current life science trade financing exercise:

—Frontier Medicines, developer of focused medicines for oncology and immunology, closed $80 million in financing to assist 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 lively 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 Part 1/2 research, Frontier stated the brand new capital will assist different wholly owned applications 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 extra $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 option 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 primary Part 3 aim assessing ache aid in comparison with a placebo. However on a secondary aim of displaying superiority to plain of care Vicodin, the Vertex drug got here up quick.

Thousand Oaks, California-based Latigo claims its drug could possibly be greatest within the class of NaV1.8 inhibitors with speedy onset, significant efficacy, and superior security. It’s at the moment in Part 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 deal with 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 shaped the corporate. The preclinical biotech, which focuses on growing therapies for immune problems of the pores and skin, was shaped by combining six Medicxi portfolio corporations. Goal indications embrace atopic dermatitis, vitiligo, psoriasis, and mastocytosis.

—Antibody drug conjugate developer ProfoundBio closed $112 million in financing, which shall 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 Part 1/2 research is underway in ovarian most cancers. Ally Bridge Group led the Seattle-based biotech’s Collection B spherical. ProfoundBio, whose administration crew 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 International Buyers 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 Part 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 remedy 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 quick period of impact. Basking plans to start out Part 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 grow to be virtually any kind of cell. Neurona will apply the capital towards ongoing Part 1/2 testing of NRTX-1001, developed as a one-time remedy to silence epileptic seizures. Viking International Buyers 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 Part 2 testing. Chicago-based Cour needs to develop its personal drug candidates and it raised $105 million to assist applications 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 shaped with property 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 property 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 focus on and likewise has the power to penetrate into the central nervous system. The Wilmington, Delaware-based firm is testing this molecule in a Part 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.

Photograph by Eli Lilly