Positive phase 1 results announced for oral acromegaly drug
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Phase 1 findings from a proof-of-concept study suggest that an oral version of the somatostatin analogue octreotide had a bioavailability of the biologic drug that was greater than 70% when compared with the IV injection formulation, according to a press release from Rani Therapeutics.
The study achieved its primary and secondary endpoints, demonstrating the safety and tolerability of oral octreotide-RP, according to the company. The drug is used for the treatment of acromegaly and neuroendocrine tumors.
“This study brings hope for the millions of patients who have long demanded an effective, alternative to painful recurring injections,” Mir Imran, CEO and chairman of Rani Therapeutics, said in the release. “We have demonstrated that we can safely and effectively deliver biologic drugs orally using the RaniPill platform, and we are now one step closer to making recurring injections for chronic diseases a thing of the past.”
The phase 1 clinical study of octreotide-RP was conducted in Australia with 58 healthy adult volunteers aged 18 to 55 years. Within the cohort, 52 participants were treated with octreotide-RP and six participants received an IV injection of an identical dose of octreotide (controls). Results of the study demonstrated that the bioavailability of octreotide-RP was greater than 70%. There were no serious adverse events.
“Current octreotide delivery methods compel patients to choose between painful injections and living with debilitating symptoms, especially occurring at the end of injection cycles,” Shlomo Melmed, MB, ChB, FRCP, MACP, dean, executive vice president and professor of medicine at Cedars-Sinai Medical Center in Los Angeles, and an Endocrine Today Editorial Board Member, said in the release. “By providing an oral alternative like octreotide-RP, Rani Therapeutics is making therapy easier and painless for patients, a welcome change for acromegaly and neuroendocrine tumor patients.”
Disclosure: Imran is CEO and chairman of Rani Therapeutics.